1

Conventional vs. Religious Cognitive Processing Therapy for Soldiers

and U.S. Veterans with Post-Traumatic Stress Disorder

Having resilient and fit active duty soldiers who make up our armed forces and mentally

healthy veterans who return from combat zones is critical to our success in preserving the

freedom of our citizens and people throughout the world. In 2008, a RAND Corporation

report estimated that nearly 20% of members of the U.S. armed forces (about 300,000

individuals) returning from Iraq and Afghanistan reported symptoms of post-traumatic

stress disorder (PTSD) or major depression.1 PTSD is one of the most prevalent and

disabling psychiatric disorders in military populations2 and is a major risk factor for

suicide.3 PTSD is also the most common mental disorder among Iraq and Afghanistan

veterans presenting for treatment at Veterans Affairs (VA) facilities.4 Only 20-30% of

those with PTSD experience improvement that could be characterized as remission.5

Religious beliefs are important to many soldiers and veterans, often used to cope with the

stress of war and trauma, and predict faster recovery in those with PTSD. In contrast,

religious struggles and moral injury are associated with prolonged recovery and

continued need for mental health services. A therapy that utilizes military personnel’s

religious resources and addresses religious struggles and moral injury may be more

effective than one that ignores them.

Duke University Medical Center, in collaboration with Eisenhower Army Medical

Center (EAMC), Charlie Norwood VA Medical Center (CN-VAMC), and Womack

Army Medical Center (WAMC), proposes a randomized clinical trial of CPT vs. RCPT

for active duty soldiers and veterans with PTSD who have co-morbid combat-related

physical injuries or illness and sleep problems. Soldiers/veterans will be enrolled if they

(a) are at least somewhat religious, (b) have PTSD diagnosed with the SCID5

(subthreshold PTSD, PTSD without complications, PTSD with complications), (c) score

27 or higher on the PCL-5, (d) have at least one co-morbid physical injury/illness, and (e)

have sleep problems. Participants will be randomized to twelve 50-min sessions over 6

wks of either standard Cognitive Processing Therapy (CPT) or religiously-integrated CPT

(RCPT), and randomly assigned to master’s level counselors trained to deliver both

treatments. Participants will be assessed blind to treatment group at baseline, 3, 6, 12,

and 24-weeks using PCL-5, Pittsburgh Sleep Quality Index, Hospital Anxiety/Depression

Scale, the ASSIST (substance abuse symptoms), and Moral Injury Scale, along with

standard multi-item measures of religiosity, hope, purpose and meaning, optimism, self-

esteem, post-traumatic growth, guilt & shame, and spiritual struggles. Christian, Jewish,

Hindu, Buddhist, and Muslim versions of RCPT will be developed to match the soldiers’

or veteran’s faith tradition and preference. Six master’s level counselors, two at each

site, will be trained to deliver both CPT and RCPT, to whom participants will be

randomly assigned. Power analyses indicate that a sample size of 300 is needed to have

80% power to detect a small to moderate difference in treatment effect (d=0.38) at

p=0.05 (2-tailed test) for the primary study aim.

A majority of psychotherapy clients (55% to 74%) have expressed a desire to

discuss religious/spiritual issues during therapy,6,7

and we anticipate that this will be true

for many soldiers and veterans frustrated that their symptoms are not responding to

traditional treatments (only 20-30% of those with PTSD experience improvement that

could be characterized as remission8). If the efficacy of RCPT is established, the plan is

2

to train military chaplains on how to administer RCPT, both in the treatment and the

prevention of PTSD. The significance of this research program is that it may help

soldiers use their existing religious or spiritual resources to recover from (or avoid)

psychological trauma from war and provide a transformative experience resulting in

greater resilience while on active duty (for soldiers) and throughout the rest of their lives

(soldiers & veterans).

Background

The lifetime prevalence of PTSD in the general community, according to the U.S.

National Comorbidity Survey, is 7.8%.9 Rates of PTSD and associated comorbidities,

however, are much higher among veteran and active military personnel. The lifetime

prevalence of PTSD has been reported to be 15% in studies of Vietnam veterans, with

one-month prevalence rates ranging from 2-15% and up to 36% in those exposed to high

war zone stress.10,11

A recent meta-analysis of studies examining active military

personnel (Canadian, US, and UK forces) following deployment to Iraq and Afghanistan

reported that PTSD was highest in those involved in combat (10.9-13.4%) and those

returning from Iraq (11.3-14.4%), compared to those deployed to Afghanistan (4.6-

9.6%).12

PTSD Spectrum

The target of this proposal is soldiers and U.S. veterans with subthreshold PTSD,

uncomplicated classic PTSD, and complicated PTSD with co-morbid mental illness, all

who also have co-occuring physical health problems. PTSD has long been known to

exist on a spectrum from adjustment disorder (with significant sub-threshold PTSD

symptoms), to standard uncomplicated PTSD, and to severe PTSD complicated with

multiple co-morbidities.13

In a recent WHO report on structured psychiatric interviews

conducted on 23,936 persons (non-military) in 13 countries experiencing some type of

traumatic event, researchers found a prevalence of 3.0% for DSM-5 PTSD and 3.6% for

those who met two or three of DSM-5 criteria B-E (subthreshold PTSD).14

Similar to

those with standard PTSD, individuals with subthreshold PTSD had significantly

elevated scores on distress-impairment, suicidality, comorbidity, and symptom duration.

Studies in U.S. veterans likewise report high rates of subthreshold PTSD associated with

significant mental and physical comorbidity. For example, in a random sample of 815

U.S. veterans seen in four VA primary care clinics in South Carolina evaluated with a

DSM-IV structured psychiatric interview (CAPS), 12.5% met criteria for classic PTSD

and an additional 4.0%-9.7% met subthreshold criteria depending on diagnostic

method.15

When compared to those without PTSD, veterans with subthreshold PTSD

had significantly greater PTSD symptom severity, poorer mental health overall, and

poorer physical health (based on SF-36) (all p<0.001, regardless of how subthreshold

PTSD was diagnosed).

Psychiatric comorbidity

PTSD also seldom exists as a pure disorder. The reality is that more than 80% of

persons with PTSD lasting 3 months or longer have one or more co-morbid psychiatric

disorders.16

The most common psychiatric disorders comorbid with PTSD are mood

disorders, anxiety disorders, and substance abuse. The National Comorbidity Survey

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found that even when PTSD was diagnosed in non-military community settings, the

lifetime prevalence of comorbid major depression and dysthymia were 47.9% and 21.4%,

respectively, and alcohol and drug abuse/dependence in 51.9% and 34.5%, respectively.17

Other studies have reported that major depression alone is present in 29.9% to 53.0% of

those with PTSD.18,19

Psychiatric comorbidity is even higher in veterans and active military with PTSD.

One study of 2,490 Vietnam veterans found that among those with PTSD, 66% met

criteria for a depressive or anxiety disorder and 39% for alcohol abuse or dependence.20

In a study of 3,016 Vietnam veterans, once considered the most comprehensive

epidemiological study of veterans’ psychological adjustment, 98.9% of males with PTSD

met criteria for another psychiatric disorder at some point in their lives.21

Psychiatric comorbidity is especially high in veterans with both PTSD and

physical health problems. Depression is not only widely prevalent but increases with

time in medically ill veterans with PTSD.22

Likewise, substance abuse/dependence has

been documented in 64% to 74% of veterans hospitalized for PTSD, and in up to 84% of

those seeking outpatient treatment for PTSD.23

When psychiatric comorbidity24

is combined with physical illness/injury,25

the

risk of suicide among military personnel with PTSD increases dramatically,26

especially

in those with TBI.27

Suicide rates in active duty US soldiers increased by over 50% from

10.3-11.3 per 100,000 in 2005 to 16.3 per 100,000 in 2008, and since 2009, suicide rates

in the military have stabilized at approximately 18 per 100,000.28

Risk is especially

higher in those with PTSD. Among soldiers who screen positive for PTSD using the

PCL, the risk of completed suicide is nearly 80% higher than among soldiers who score

below PCL cutoff scores.29

Cognitive therapies have been shown to reduce suicidal

behaviors30

and may be an effective way to reduce suicide in active duty soldiers and

veterans with PTSD.31

Insomnia

Likewise, sleep problems are widely prevalent among soldiers/veterans,

especially those with PTSD. One study found that 72% of active duty soldiers sleep less

than 6 hours per night (considered “short sleep duration”)32

and nearly half of U.S.

veterans meet criteria for insomnia.33,34

Insomnia is the most commonly reported

symptom and predicts other symptoms of post-traumatic stress disorder in U.S. service

members returning from military deployments .35

The same is true for veterans, and sleep

problem are thought to be likewise related to PTSD.36

Research indicates that 70-91% of

persons with PTSD have difficulty falling or staying asleep,37

including active duty

soldiers38

and veterans39

(and have been shown to be effectively treated with cognitive-

behavioral intervention).40

Physical Comorbidity

In addition to co-morbid psychiatric disorders, as noted above, many soldiers and

veterans will have traumatic war injuries or other health problems that cause physical

disability. Burns, fractures, soft tissue injuries, and traumatic brain injury are the most

common physical injuries that result from conventional warfare.41,42

When physical

health problems are present the risk of PTSD is much higher, and in fact, increases over

time. In a study of troops following return from deployment to Afghanistan or Iraq, rates

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of PTSD ranged from 12.2% to 12.9%. In those with direct combat exposure and minor

wounds or injury, however, the prevalence of PTSD was over three times higher.43

In a

survey of 2,863 soldiers 1 year after deployment to Iraq, among those who were wounded

or injured one or more times, 31.8% (150 of 471) met PTSD criteria, compared to only

13.6% (311 of 2,287) of those without injuries (OR=2.97, 95% CI=2.36–3.73).44

In a

study of 613 U.S. soldiers hospitalized at Walter Reed Army Medical Center following

serious combat injury (amputations, fractures, closed-head trauma, open cranial trauma,

chest trauma, ocular injury, spinal cord injury, and muscle, nerve, and vascular injuries

caused by shrapnel or gunshot wounds), researchers found at 1 month that only 4.2% of

the soldiers had probable PTSD; by 4 to 7 months later, however, the figure nearly tripled

to 12%.45

In another study of over 13,000 soldiers returning from deployment to Iraq,

rates of PTSD and depression after returning from combat ranged from 9% to 31%

depending on the level of physical disability reported.46

Chronic pain and cardiovascular

disease are likewise common in active duty soldiers and veterans with PTSD.47,48

Moral Injury

Since the 1980’s, war-time experiences such as violence, direct or indirect killing

of enemy combatants and non-combatants (innocents), observing the death of fellow

soldiers, and surviving when others have died, have been known to cause internal ethical

conflict, guilt, and persistent distress.49

Only within the past 5-10 years, however, has the

concept of “moral injury” received serious attention or been connected with PTSD, partly

because of the resistance of PTSD to current treatments.50,51,52

Those with moral injury

view themselves as immoral, irredeemable, and un-repairable, or believe that they live in

an immoral world, making PTSD more difficult to treat unless this issue is addressed in

therapy.53

Soldiers and veterans who are religious, have a religious background, or have

been raised in a religious environment may be particularly vulnerable to moral conflict.54

Psychological Therapies for PTSD

A recent review of psychological therapies for the treatment of PTSD found that

the use of cognitive processing therapy (CPT) and prolonged exposure therapy (PE),

which itself is based on CPT,55,56

are the primary evidence-based treatments used today.57

The effect sizes in clinical trials have generally been larger for these therapies than for

those achieved by medication.58

CPT in particular has received increasing attention for

the treatment of PTSD in soldiers and veterans.59,60,61,62,63,64,65,66

Both CPT and PE are

manualized cognitive-behavioral interventions typically delivered in 12 sessions over 6-

12 weeks.67,68

More than 2,300 VA clinicians have been trained in CPT and 1500 in PE,

testifying to the effectiveness of these treatments.69,70

In fact, the VA has mandated that

veterans with PTSD receive either CPT or PE.71

Unfortunately, these treatments seldom

address the issue of moral injury and loss of faith, and despite the mandate, less than 10%

of veterans with PTSD have completed a course in either CPT or PE.72,73,74

Religiously-Integrated Psychotherapy

While there are many reasons why soldiers and veterans with PTSD are failing to

complete CPT, one reason may be that those with strong religious beliefs might perceive

these therapies as conflicting with their religious beliefs. Indeed, religious individuals

often shy away from psychological therapies that are viewed as conflicting with their

5

beliefs systems. The long history of discord between religion and mental health care

began nearly a century ago with Freud’s description of religion as “the universal

obsessional neurosis.”75

A systematic review of the religious content of DSM-III-R

found that nearly one-quarter of all cases of mental illness included religious

descriptions.76

More recent publications by mental health professionals continue to

reinforce the lack of concern for patients’ religious beliefs,77,78

and a recent national

survey of U.S. psychiatrists found that 56% never, rarely, or only sometimes inquire

about religious/spiritual issues in patients with depression or anxiety.79

Based on this generally neglectful (and sometimes disparaging) attitude of many

mental health professionals toward religion, religious professionals are often reluctant to

refer members of their congregation to mental health professionals, especially for

psychotherapy that seeks to alter religious beliefs and attitudes. Given that clergy

represent a major first line treatment for depression in the community,80

the failure of

clergy to refer may prevent many patients from receiving adequate treatment, including

soldiers after discharge from the army. Furthermore, for military personnel who do

participate in therapy and are members of a faith community, if their religious community

does not support (or counteracts) the gains made in psychotherapy, then those gains may

not last or treatment may be prematurely discontinued.

Thus, an evidence-based psychotherapy for PTSD that utilizes soldiers’ and

veterans’ religious beliefs as part of the therapy may open the door for many military

personnel with PTSD in need of treatment. A religious form of CPT that targets moral

injury may be particularly effective, as religious struggles and even loss of faith are often

present in those with combat-related PTSD.81,82,83,84

For example, in a collaborative

effort between the VA National Center for PTSD and Yale University, researchers

examined 1,385 veterans from Vietnam and WW-II or Korea to determine predictors of

continued use of VA mental health services.85

Loss of religious faith as a result of killing

others or failing to prevent the death of fellow soldiers was one factor measured.

Interestingly, loss of faith was one of the most powerful predictors of VA mental health

service use, more powerful than baseline severity of PTSD symptoms or deficits in social

functioning. Researchers concluded that: “This possibility raises the broader issue of

whether spirituality should be more central to the treatment of PTSD, either in the form

of a greater role for pastoral counseling or of a wider inclusion of spiritual issues in

traditional psychotherapy for PTSD” (p 579).

Rationale for Addressing Religious Beliefs in Therapy

Research indicates that greater religiosity predicts a faster resolution of depressive

symptoms over time in those with physical illness (increasing speed of remission by 50 to

70 percent).86,87,88

This research includes medically ill U.S. veterans.89

Likewise, in a

study of 600 veterans discharged from a substance abuse program, religious involvement

predicted a 34% lower likelihood of being re-hospitalized during follow-up (RR=0.66,

95% CI 0.39-0.92).90

Furthermore, religious involvement (private religious activity and

religious attendance) has been shown to distinguish resilient from non-resilient veterans

in the National Health and Resilience in Veterans Study. 91

Religious involvement did so

by increasing emotional stability, serving as a protective psychosocial factor, and

increasing social connectedness.

6

Veterans with PTSD serving in Iraq/Afghanistan have more religious struggles

and lower self-rated religiosity compared to a matched sample of younger adults from the

General Social Survey. The finding caused researchers to conclude that “the empirical

and clinical information presented here highlights the need for expanded bio-

psychosocial-spiritual models of trauma that can account for both the adaptive role of

religion/spirituality and address spiritual struggles in the recovery process.”92

Studying a

population of veterans returning from Iraq/Afghanistan, Ogden and colleagues likewise

found that PTSD symptoms were significantly and positively associated with alienation

from God, religious rifts, religious fear, and religious guilt.93

In contrast, post-traumatic

growth (PTG) was significantly and positively associated with religious coping and

prayer.

Studies reported within the past 12 months reinforce these findings. For example,

religiosity/spirituality (R/S) has also recently been associated with PTG in a population-

based survey of U.S. veterans.94

In that study, researchers in the Department of Veterans

Affairs and in the Department of Psychiatry at Yale University analyzed data from the

National Health and Resilience in Veterans Study that surveyed a nationally

representative sample of 3,157 veterans in late 2011. The measures administered

included a Trauma History Screen, the 17-item PTSD Checklist (PCL-S), and a 10-item

Post-Traumatic Growth (PTG) Inventory-Short Form. In multivariate analyses that

controlled for other risk factors, R/S was significantly and positively related to every

aspect of PTG, including growth in intimate relationships (p<0.001), growth in new

possibilities (p<0.001), growth in personal strength (p<0.001), spiritual growth

(p<0.001), and growth in appreciation for life (p<0.001). In fact, of the 21 predictors

that were examined, R/S was the second strongest predictor of overall PTG, and stronger

than any psychological or social measure.

Military personnel with religious or spiritual resources have better outcomes than

non-religious personnel in response to inpatient treatment programs for severe PTSD.

For example, researchers from the National Center for PTSD at the Stanford University-

Palo Alto VA examined baseline R/S as a predictor of PTSD outcomes in 532 veterans

completing a 60-90 day residential treatment program for combat-related PTSD.95

R/S

was assessed during the first week of the program and then again at discharge. PTSD

severity was measured using the PCL-M at baseline and follow-up. Researchers were

particularly interested in the cross-lagged effects (R/S predicting PTSD severity vs.

PTSD severity predicting R/S) in order to determine “direct of effect.” Results indicated

that baseline spirituality predicted significantly lower PTSD severity at discharge,

independent of baseline PTSD severity. The cross-lagged effect of baseline R/S

predicting discharge PTSD severity (p<0.05) was stronger than the cross-lagged effect of

baseline PTSD severity predicting discharge R/S (p=ns), a finding that held up after

controlling for confounders. R/S struggles, in contrast, were associated with worse PTSD

outcomes, as many other studies have reported.96,97,98

R/S struggles could also serve as a

target for a religiously-integrated CPT that focuses on strengthening spiritual and

psychological resiliency.

Religious and Spiritual Therapies

Spiritual therapies have been effective in treating PTSD symptoms in military

populations. For example, Bormann and colleagues examined the effectiveness of a

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spiritual intervention (meditating using a sacred word/phrase) in reducing anxiety

symptoms in veterans with PTSD.99

Subjects were randomly assigned to the spiritual

intervention (n = 14) or delayed-treatment control (n = 15). Measures were PTSD

symptoms, psychological distress, quality of life, and patient satisfaction. The spiritual

intervention produced large effect sizes for reducing PTSD severity (d =–.72),

psychological distress (d =–.73), and increasing quality of life (d =.70). Mindfulness

meditation, a Buddhist form of contemplative prayer, has also received increasing

attention as a treatment for PTSD.100,101,102

In related research, religiously-integrated CBT has been shown to increase the

speed of remission in depressed religious patients above and beyond that achieved by

conventional CBT.103,104

Likewise, a number of studies that have utilized patients’

religious beliefs in psychotherapy have reported results superior to secular treatments or

usual care, especially in religious patients.105,106,107,108,109

Religiously-integrated CBT has

been shown to effectively treat major depression in persons with chronic medical illness,

especially in more religious clients. 110

A religious form of psychotherapy for the

treatment of soldiers and veterans with PTSD, however, has yet to be developed or tested.

Will Soldiers and Veterans Be Receptive?

Religious involvement is important to many in the general U.S. population, from

which soldiers and veterans are drawn.111

A January 2009 Gallup Poll reported that 65%

of Americans said that religion is an important part of their daily life, a figure which

increased to over 75% in the southeastern U.S. (where the present study is planned).112

This is especially true for people with physical disability, who often turn to religious

beliefs to cope with health problems. In some areas of the U.S., nearly 90% of persons

with physical illness use religion to cope and of those, nearly half (45%) report that

religion is the most important factor that keeps them going.113

High rates of religious

coping have likewise been documented in veterans with physical illness.114,115

Although

not yet studied in military populations, research indicates that 55% to 74% of

psychotherapy clients express a desire to discuss religious/spiritual issues during

therapy.116,117

What do we know about the religious interests of active duty soldiers? In 2011 a

survey of 34,416 military personnel in the Department of Defense (i.e., Army, Navy, Marine

Corps, Air Force) and 5,461 personnel in the Coast Guard found that nearly two-thirds

(63.6%) classified themselves as medium (35.3%) or high (28.3%) on religiosity/spirituality

(R/S), whereas 14.0% indicate low and 22.4% indicated not applicable.118 Soldiers reporting

high R/S experienced less heavy alcohol use (4.8% vs. 8.4%), less cigarette smoking (15.9%

vs. 24.0%), less drinking and driving (4.0%), and less negative affect (6.7% vs. 9.6%)

compared to those reporting lower levels of R/S. According to the most recent survey in

2013, 74% of active duty Army personnel (n=528,070) indicated a religious affiliation,

and in an additional 8%, religious affiliation was unknown (some of whom may also have

been religiously affiliated).119

Of those with a religious affiliation, 97% were Christian

(53.1% Protestant, 18.9% Catholic, 0.1% Orthodox). Only 0.6% described themselves

as atheist.

Bear in mind that these figures are for active duty soldiers in general, and are not

specific to soldiers returning from war zones or injured during combat. Because religion

is often used to cope with distress, religious involvement may be even higher in military

personnel with PTSD, as research has suggested.120

Furthermore, consistent with

8

culturally competent therapy, a religiously-integrated CPT may be particularly attractive

to and appreciated by soldiers and veterans from minority populations (Blacks,

Hispanics, etc.) who tend to be much more religious than Caucasians, a pattern that is

also seen in the general population.121,122

For many active duty soldiers and U.S.

veterans, then, we estimate that receptivity will be high to a religiously-integrated form of

psychotherapy for PTSD. This would be particularly true if religiously-integrated CPT

addressed religion/spirituality as both a coping resource and a potential source of moral

conflict and pain (i.e., spiritual struggles).

Summary

PTSD and its associated mental comorbidities, particularly insomnia, and physical

health problems (1) are widespread among U.S. soldiers and veterans who have been

deployed to combat zones, (2) cause tremendous emotional and physical disability, and

(3) may be influenced both in their development and course by religious involvement.

War time experiences can also affect soldiers’ and veterans’ religious beliefs and cause

moral injury and religious struggles, reducing resiliency and adversely affect ability to

cope with stress and deal with sleep problems.123,124

While a recent review of

psychological therapies for PTSD in the military indicated that “the vast majority of

articles focus on cognitive-behavioral approaches to treatment, and this area of the

literature present strong evidence for these approaches,” researchers acknowledged that

further randomized clinical trials are necessary since PTSD is often a challenging and

treatment-resistant condition.125

Religious beliefs are prevalent among soldiers and

veterans, and these are often used to cope with stressors related to war-time experiences,

injuries and disabling health problems. Moreover, religious beliefs and involvement has

been associated with faster recovery from PTSD in observational studies.126,127

A

psychological therapy that takes advantage of soldiers’ and veterans’ religious resources

and addresses spiritual struggles and moral injuries, then, has the potential to improve

PTSD and its associated comorbidities more quickly than one that ignores them. The

goal of religiously-integrated CPT is to heal and increase the resiliency of military

personnel with PTSD and co-morbid conditions, and counter the high rate of suicide

associated with this disorder. Resilient soldiers will make better soldiers, and resilient

veterans will be more productive citizens and family members.

Specific Aims

Specific Aim #1. Determine if RCPT is more effective than CPT in the treatment of

soldiers and veterans with PTSD and physical health problems.

Hypothesis #1.1: RCPT will be more effective than CPT in reducing severity of PTSD

symptoms by the end of treatment (6 weeks from baseline).

Hypothesis #1.2: The superiority of RCPT over CPT will persist for at least 18 weeks

after treatment has ended (24 weeks from baseline).

Specific Aim #2. Examine the effectiveness of RCPT vs. CPT on co-morbid mental

disorders and sleep problems.

Hypothesis #2: RCPT will be more effective than CPT in decreasing depressive

symptoms, anxiety symptoms, substance use, and sleep problems; differences in

9

treatment effects will be present by 6 weeks from baseline (at the completion of therapy)

and will persist for at least 18 weeks afterwards (24 weeks).

Specific Aim #3. Identify psychological and social mechanisms by which RCPT has its

effects.

Hypothesis #3: RCPT will be more effective than CPT in increasing hope, purpose and

meaning in life, optimism, self-esteem, and post-traumatic growth, increasing social

support, and reducing shame, guilt, and negative religious coping, which will mediate and

at least partially explain the superiority of RCPT over CPT in relieving PTSD symptoms.

Specific Aim #4. Examine the effectiveness of RCPT vs. CPT on moral injury, a known

factor that may lead to treatment resistance.

Hypothesis #4: RCPT will be more effective than CPT in reducing moral injury;

differences in treatment effects will be present by 6 weeks from baseline (at the

completion of therapy) and will persist for at least 18 weeks afterwards (24 weeks).

Specific Aim #5. Religiosity will moderate the effect of RCPT on PTSD symptom

severity, co-morbid mental disorders, and sleep problems.

Hypothesis #5: RCPT will be especially effective in those who are more religious at

baseline (i.e., score ½ standard deviation or more above the mean on our multi-

dimensional religiosity scale). This moderating effect of religiosity will be observed at 6

weeks from baseline (at the completion of therapy) and will persist for at least 18 weeks

afterwards (24 weeks).

METHODS

We propose a head-to-head randomized clinical trial involving 300 eligible soldiers and

veterans recruited from two army medical centers and a VA medical center (including

both outpatient and inpatients). A total of 100 active duty army soldiers will be recruited

from EAMC, 100 from WAMC, and 100 veterans from CN-VAMC.

Inclusion/Exclusion Criteria

Inclusion criteria are (1) a diagnosis of PTSD or subthreshold PTSD on the SCID-

5; (2) a score of 27 or higher on the PCL-5 (equivalent to 40 or higher on PCL-S); (3) any

comorbid physical illness resulting from combat injury or other medical illness lasting at

least one month or longer; (4) problems falling or staying asleep; (5) religion is self-rated

as at least somewhat important; (6) English-speaking; and (7) willingness to provide

written informed consent, and complete follow-up interviews. Exclusion criteria are (1)

cognitive dysfunction as indicated by a score of 13 or lower on the 18-item abbreviated

Mini-Mental State Exam; (2) receipt of CPT within the past 4 weeks; and (3) active

suicidal ideation with significant risk. Participants will be allowed to have other co-

morbid psychiatric disorders (depressive disorder, bipolar disorder, anxiety disorder,

substance abuse) that will be documented at baseline using the SCID-5. Participants will

be allowed to take medication for psychiatric symptoms, including antidepressants

(SSRIs) as recommended by the DOD-VA Clinical Practice Guidelines, although the

regimen should be stable or unchanged within the past month.128

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Feasibility

Eisenhower Army Medical Center. Clinicians at this facility see 10 new and 40-

50 ongoing cases of PTSD per month (75% with comorbid psychiatric or medical

disorders). During a 24-month recruitment period, this means that 240 new cases of

PTSD and over 1,000 soldiers being followed for PTSD will come through the doors. If

50% have co-morbid physical problems, there will be over 600 soldiers from which 100

participants will need to be enrolled.

This does not include the large number of soldiers with PTSD symptoms at Fort

Gordon returning from deployment to war zones who are not currently being treated but

who may be eligible to participate in this study and could be identified by advertising,

word of mouth, or screening. Note that in a recent study (November 2013) of 1,707

soldiers of an infantry brigade that participated in the Walter Reed Army Institute of

Research Land Combat Study, 16% scored 28 or higher on the PCL-5 and among the 937

returning from Iraq or Afghanistan, 24% scored 27 or higher.129

Surveys indicate that

only about 23% to 40% of soldiers with PTSD and other disorders seek help for their

symptoms,130

meaning that many soldiers at Fort Gordon with significant symptoms may

not be receiving treatment.

Womack Army Medical Center. Clinicians see 40 new and 200 ongoing cases of

PTSD per mo, four times the number seen at EAMC. During a 24-month period, then,

close to 1000 soldiers with new PTSD will be assessed and at least 2,000 with ongoing

PTSD will be followed. Again, this number does not include soldiers with subthreshold

PTSD or those with PTSD who have not sought help for their symptoms (identified by

screening or advertisements) who would be eligible for the study.

Charlie Norwood VA Medical Center. Clinicians at CN-VAMC see 90 new

veterans with PTSD per month and follow 150-200 veterans with PTSD. Therefore,

during a 24-month recruitment period, clinicians will see 2,160 new cases of PTSD and

follow up at least 1,500-2,000 veterans with PTSD. Again, if 50% have co-morbid

physical health problems, there will be over 2,000 veterans from which 101 veterans will

need to be enrolled. If there are problems meeting the recruitment goal at the other sites,

we believe that at least 150 veterans could be enrolled from the CN-VAMC site.

As with EAMC and WAMC, there may also be many veterans receiving

treatment at CN-VAMC for other psychiatric disorders or for medical problems, veterans

who have PTSD symptoms but have not received treatment for these symptoms and so

may be eligible to participate in this study (and, as at Fort Gordon, could be identified by

advertising, word of mouth, or screening). In one survey of over 103,000 veterans from

Iraq or Afghanistan receiving VA outpatient services, 13% had a diagnosis of PTSD

documented in their medical records (not counting those who were not assessed for

PTSD).131

An additional 4-10% of veterans are likely to have subthreshold PTSD that is

associated with considerable mental and physical co-morbidity.132

In conclusion, there should be adequate numbers of soldiers and veterans with

PTSD or subthreshold PTSD at the three sites above who could be enrolled into the study

to meet recruitment goals.

11

Procedure Potential participants will be screened in-person or by telephone to determine if

they meet the initial eligibility criteria based on inclusion/exclusion criteria. This initial

screening can quickly determine the presence of (a) a prior diagnosis of PTSD or PTSD-

like symptoms resulting from war-time experiences or sexual assault, (b) one or more co-

morbid physical health problems, (c) if participant is at least somewhat religious, (d)

willing to participate in study and go through the follow-up assessments, and (e) absence

of CPT in the past 4 weeks. At EAMC and WAMC, research coordinators (RC) may

invoke/use a partial HIPPA waiver, which will enable them to go through the medical

records to identify soldiers who are potentially eligible for the study, and then cold-call

them (without separate approval from treating clinicians). This may also be possible at

the Augusta VAMC. In addition, flyers for the study will be posted, posters developed,

and staffers/chaplains encouraged to identify potential participants and direct them to the

RC.

After screening the participant by telephone, a visit will be arranged when in-

person informed consent will be obtained and further screening conducted to ensure that

all inclusion/exclusion criteria are met. Participants who meet eligibility criteria will then

complete a baseline evaluation, be provided with a description of the two treatment

options (CPT and RCPT), be asked to choose their preferred religion (should they be

randomized to the RCBT condition), and then randomized to RCPT or CPT. A separate

Clinical Trials Control Center (CTCC) will randomize participants to treatment group

using a 4-person block design to ensure similar numbers in each group, as well as

randomize them to therapist. The assignment will be provided by the RC to the

participant in a sealed envelope that contains the treatment arm and therapist to which the

participant is assigned. This assures that the RCs (interviewers) remain blind to treatment

group. The CTCC will then connect participants with their therapists for an initial

meeting, and will schedule and track treatment sessions and follow-up assessments at 3

weeks, 6 weeks, 12 weeks and 24 weeks from baseline. We will obtain approval from

the Institutional Review Boards at DUMC, EAMC, WAMC, and CN-VAMC to conduct

the study.

Interventions

Conventional CPT. CPT is an established and proven treatment for PTSD, and is

recommended as one of the primary evidence-based trauma-focused psychotherapies for

PTSD according to the DOD-VA Clinical Practice Guidelines.133

CPT differs from PE in

that the former is more heavily based in the social cognitive theory of PTSD, which

emphasizes how certain emotional responses (e.g., shame, guilt, anger, humiliation) result

from erroneous interpretations of the trauma.134

CPT will be carried out by therapists

guided by the standard CPT manual, with workbooks for therapist and patient.

More specifically, when an individual has faced a traumatic event, he/she will

cognitively try to reconcile the information about the event with previous schemas. As a

result, he/she will go through one of three cognitive processes: 1) assimilation, i.e., alter

the incoming information to match prior beliefs; 2) accommodation, i.e., alter beliefs

enough to incorporate the new information; and 3) over-accommodation, i.e., alter beliefs

about oneself and world to an extreme degree in order to feel safer and in more control.

CCPT helps the individual accommodate or alter beliefs associated with the trauma to

12

incorporate new information and allow the individual to be able to fully process the

trauma affectively. During the process of accommodation, as beliefs associated with the

trauma are challenged, it is expected that secondary emotions and intrusive reminders

will dissolve.

The main aspects of CCPT include (a) educating the individual about PTSD and

the efficacy of treatment; (b) helping him/her to become aware of the connection between

cognitions and emotions associated with the trauma; (c) utilizing cognitive restructuring

and Socratic questioning to challenge maladaptive thinking patterns, particularly those

related to blame and guilt; and (d) addressing topics such as safety, trust, power/control,

esteem, and intimacy that may have been disrupted as a result of the trauma.135

Religiously-integrated CPT. The CPT manual used for the CPT group will be

adapted to create a religiously-integrated form of CPT. This procedure will follow that

used in our previous work developing religiously-integrated CBT (cognitive behavioral

therapy).136

The latter has been shown to effectively treat clients with major depressive

disorder in the setting of chronic health problems, especially in clients who are more

religious.137

As with our RCBT intervention, RCPT will be manual-based and

workbooks for therapist and patient will be developed for Christian, Jewish, Muslim,

Buddhist, and Hindu faith traditions.

RCPT targets erroneous interpretations of trauma by focusing on cognitive

restructuring using clients’ religious resources (i.e., religious beliefs, practices, scriptures,

values, and motivations) to challenge maladaptive thinking patterns. Religious concepts

of mercy, grace, repentance, forgiveness, spiritual surrender, prayer/contemplation,

divine justice, hope, and divine affirmations are discussed as means to reverse negative

emotional responses, such as shame, guilt, anger, and humiliation. These are

supplemented by powerful religious confession and forgiveness rituals, song, and

emersion within a faith community. Moral injury and spiritual struggles are specifically

addressed. Many great religious figures engaged in battle and killed – including

Abraham, Moses, Joshua, David (author of the Psalms), the Prophet Mohammad, and

Lord Krishnan. These individuals are presented as role models that soldiers/veterans may

identify with.

Prior to randomization, participants will have the five types of RCPT explained to

them and they will choose which type they wish to receive should they be randomized to

the RCPT arm. Our religious CBT intervention has been standardized, field-tested, and is

available on the Duke University website (therapy manuals, therapist workbook, and

client workbook for the conventional CBT and for each of the five religiously-integrated

CBT treatments).138

Numerous publications from our recent multi-center trial using these

interventions are either in print, in press, or in

submission.139,140,141,142,143,144,145,146,147,148,149,150

CPT and RCPT Session Outline (Christian version here; to be adapted for Jews, Muslims, Buddhists, Hindus)

CCPT Session 1: Focuses on rapport building, education on PTSD symptomatology,

providing the rationale for cognitive processing treatment of PTSD, explaining the course

of treatment, and eliciting treatment compliance. During this session, the therapist and

patient define the most traumatic event to be targeted first in treatment. For homework,

13

patients write a trauma statement describing the impact the trauma has had on their

beliefs about self, others, and the world.

RCPT Session 1: Focuses on rapport building, education on PTSD, depression, and

moral injury as a major cause/maintaining factor of PTSD (i.e., shame and guilt for not

acting in accord with their morals, values, and religious beliefs), the rationale for

Christian based cognitive processing treatment of PTSD (can use language such as,

Christ as our Commander in Chief, spiritual armor rather than physical armor, part of a

new, eternal army/family of God to provide the closeness/intimacy/brotherhood they had

in the military and have now lost), explaining the course of treatment, and eliciting

treatment compliance. During the session, the therapist and patient define the most

traumatic event to be targeted first in treatment. For homework, patients write a trauma

statement describing the impact the trauma has had on their beliefs about God, self,

others, the world, and their religious beliefs and practices and spiritual well-being.

Patients are given verse to inspire/set intention of hope (Ecclesiastes 1:1-11).

CCPT Session 2: Targets the meaning of the traumatic event. Patients are encouraged

to read the impact statement in session to elicit an affective response and reduce trauma-

related avoidance. The meaning of the impact statement is discussed. The patient is

further socialized to the CPT model by reviewing symptoms of PTSD and the theory of

PTSD treatment. The relationship between thoughts, feelings, and behavior, particularly

as they relate to the trauma, are introduced using the A-B-C worksheet. For homework,

patients complete an A-B-C worksheet daily to help identify connections between

thoughts, emotions, behavior, and trauma.

RCPT Session 2: Targets the meaning of the traumatic event, particularly as it relates to

moral injury and changes in their religious beliefs and practices. Patients are encouraged

to read the impact statement in session to elicit an affective response and reduce trauma-

related avoidance. The meaning of the impact statement is discussed and examples of

how symptoms of PTSD, moral injury, and spiritual struggles are exemplified in Biblical

stories. The relationship between thoughts, feelings, and behavior, particularly as they

relate to the trauma, are introduced using the A-B-C worksheet. Biblical example of

David and Bathsheba used for A-B-C example (war example; God as both just and

merciful; consequences for our actions, but also complete forgiveness and right-standing

before God). For homework, patients meditate on a scripture related to the session

material (David’s plea for forgiveness in Psalms) and complete an A-B-C worksheet

daily to help identify connections between thoughts, emotions, behavior, and trauma.

CCPT Session 3: Begins with review of the A-B-C worksheets completed for

homework. The therapist identifies emotional and/or cognitive themes from the

worksheets and helps patients revise any misidentified cognitions and emotions. Stuck

points, the concepts of assimilation versus (over) accommodation, self-blame, and guilt

are discussed and gently challenged through Socratic questioning. For homework,

patients write a detailed account of the trauma to include sensory details (sights, sounds,

and smells, etc.) as well as additional thoughts and emotions that are recalled about the

traumatic event. Patients also continue to complete A-B-C worksheets.

RCPT Session 3: Begins with a review of the A-B-C worksheets completed for

homework. The therapist identifies emotional and/or cognitive themes from the

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worksheets and helps patients revise any misidentified cognitions and emotions. Stuck

points are discussed, particularly as they relate to moral injury, self-blame, and spiritual

struggles. The concepts of repentance and confession are introduced as healing religious

resources. For homework, patients will write a detailed account of the trauma/moral

injury to include sensory details (sights, sounds, smells, etc.), as well as additional

thoughts and emotions that are recalled about the traumatic event/moral injury. They will

then read this statement and confess the moral injury/wrongdoing aloud daily. Patients

will be provided another scripture to meditate on (verse on confession) and will continue

to complete A-B-C worksheets.

CCPT Session 4: Begins with the reading of the trauma account. As patients read the

account, the therapist helps to identify thoughts and feelings associated with the traumatic

event. This exercise allows patients to engage in affective expression and both the

therapist and patient to identify stuck/missing points in the narrative. For homework,

patients rewrite the trauma account, providing more sensory details, thoughts, and

feelings experienced during the incident. Patients then read the trauma account every

day until the next session, as well as continue to complete the A-B-C worksheets.

RCPT Session 4: Begins with the reading of the trauma/moral injury account and

confession. As patients read the account, the therapist helps to identify thoughts and

feelings associated with the moral injury and traumatic event. This exercise allows

patients to engage in affective expression and both the therapist and patient to identify

stuck/missing points in the narrative. The therapist listens for ways patients’ religious

faith may be serving as a resource and/or a source of struggle. The concepts of grace,

mercy, divine love, and divine justice are introduced (use story of Prodigal son—father

waiting, running out to meet him; we are fully known by God and fully loved—the

ultimate desire of our hearts). For homework, patients rewrite the trauma account/moral

injury confession, providing more sensory details, thoughts, and feelings experienced

during the incident. Patients then confess the moral injury out loud daily and meditate on

relevant scriptures daily (verse on mercy/grace), as well as continue to complete A-B-C

worksheets.

CCPT Session 5: Begins with reviewing the newest version of the trauma account.

Patients are asked to identify similarities and differences between how they felt during

the incident and while writing the account. Further, patients are asked to delineate

differences between the first and second trauma account. The expectation is a lessening

of emotional intensity with the second account if they are allowed affective expression to

occur in the first account. The Challenging Questions worksheet is introduced, a tool to

assist patients in challenging their maladaptive trauma-related beliefs and stuck points,

particularly those associated with self-blame. For homework, patients use the

Challenging Questions and A-B-C worksheets to challenge one maladaptive belief daily.

If necessary, patients will also complete unfinished written trauma accounts.

RCPT Session 5: Begins by reviewing the newest version of the trauma account/moral

injury confession. Patients are asked to delineate differences between the first and

second trauma account/moral injury confession. Forgiveness and penance (praying for

those they hurt or their enemies; verbally blessing them) are introduced as ways to deal

with moral injury and self-blame. For homework, patients pray prayers requesting,

15

granting, and receiving forgiveness (or asking for the desire/willingness to forgive if they

are not ready to do so. They will also pray and say statements of blessing daily for the

people they wronged and for their enemies Patients will be encouraged to meditate on a

relevant scripture passage (verse on forgiveness).

CCPT Session 6: Begins with reviewing the challenging questions worksheets and

assisting patients in examining and working through their maladaptive beliefs. Patients

begin to take on more of an active role in therapy while the therapist takes on a more

supportive and consultative role. The Patterns of Problematic Thinking worksheet is

introduced, a tool to assist patients in identifying counterproductive thinking patterns

instead of a single thought. For homework, patients identify problematic thinking patterns

related to the traumatic event and how their reactions to the event may have been affected

by the problematic thinking patterns. If patients continue to experience intense emotions

associated with the trauma, then daily reading of the trauma account should continue.

RCPT Session 6: Begins with reviewing the forgiveness and penance exercise. The

Patterns of Problematic Thinking worksheet, with theological reflections for each pattern

of thinking, is introduced, a tool to assist patients in identifying counterproductive

thinking patterns instead of a single thought. Communion/The Eucharist is discussed as a

ritual for purification. For homework, patients identify problematic thinking patterns

related to the traumatic event, how their reactions may have been affected by the

problematic thinking patterns, and how their religious teachings (theological reflection)

help to challenge this type of thinking. Patients will also be asked to participate in

Communion/The Eucharist, pray and bless those they hurt (now referred to as penance),

meditate on a relevant scripture passage (verse on renewing the mind). They will also be

encouraged to continue the steps toward forgiveness, if there are others they need to

forgive or things they need to be forgiven for.

CCPT Session 7: Begins with reviewing the Patterns of Problematic Thinking

worksheet. Patients then learn how to replace automatic maladaptive cognitions with

more adaptive beliefs. The Challenging Beliefs worksheet is introduced on which patients

rate the strength of the emotion and the problematic thinking pattern associated with the

maladaptive thought. The Challenging Questions and Patterns of Problematic Thinking

worksheets are then used to generate a more balanced and evidenced based statement.

Finally, the topic of safety is discussed. Specifically, how previous beliefs regarding

safety might have been disrupted or seemingly confirmed by the traumatic event. For

homework, patients read the safety module in the patient workbook and complete at least

one Challenging Beliefs worksheet on a maladaptive belief associated with safety related

to self and others. If safety is not an issue for patients, then they will be encouraged to

complete worksheets on other maladaptive beliefs and recent- distressing trauma related

events.

RCPT Session 7: Begins with reviewing the Problematic Thinking worksheet. Patients

then learn how to replace automatic maladaptive cognitions with more adaptive beliefs

using their religious resources. The Challenging Beliefs and Challenging Questions

worksheet will be introduced on which participants rate the strength of the emotion and

the problematic thinking pattern associated with the maladaptive thought. The

Challenging Questions and Patterns of Problematic Thinking worksheets, along with

16

religious resources (e.g., scriptures, religious teachings, religious practices), are then used

to generate a more balanced and evidenced based statement. Finally, the topics of

spiritual grief, trusting in God, and feeling betrayed or abandoned by God are discussed.

Specifically, how these struggles and beliefs undermine their ability to trust and feel

secure. For homework, patients read the module on Divine love and meditate on

scriptures about the unconditional love and unchanging nature of God. Patients complete

at least one Challenging Beliefs worksheet on a maladaptive belief associated with

spiritual struggles, trust, and/or security. They will continue to engage in penance and

confess verses on forgiveness.

CCPT Session 8: Begins with review of Safety or Challenging Beliefs worksheets. The

therapist helps patients to challenge problematic beliefs that they were unable to

successfully complete on their own. The topic of trust is introduced and the module on

trust in the patient workbook is reviewed. For homework, patients complete at least one

worksheet that confronts maladaptive cognitions associated with trust related to self or

other, if this is an area of concern. Otherwise, patients will continue to complete

worksheets on safety or will challenge other trauma-related maladaptive beliefs.

RCPT Session 8: Begins with review of the Divine love module and Challenging Beliefs

worksheets. The therapist helps patients to challenge problematic beliefs that they were

unable to successfully complete on their own. The topic of healing (emotional, physical,

and spiritual) and scriptures associated with healing (e.g., story of Jesus by healing pool

when he asks the paralyzed man “Will you be made well?” are introduced and the

module on healing in the patient workbook is reviewed. A discussion on how God is not

bound by time or space and as such healing for traumatic memories is possible. Patients

are led through a guided imagery/prayer on finding God/Christ in the traumatic memory.

For homework, patients mentally revisit the revised memory daily, engage in penance,

and confess verses on healing.

CCPT Session 9: Begins with a review of the homework exercises. The theme of the

session is power and control and how these schemas have been affected (confirmed or

disrupted) by the trauma. For homework, patients read the power/control module in the

patient workbook and complete the worksheets on this topic related to self and others, as

well as on safety and/or trust if necessary. The challenging beliefs worksheets can also be

used to address ongoing maladaptive beliefs.

RCPT Session 9: Begins with a review of the homework. The theme of the session is

power and control and how these schemas have been affected (confirmed or disrupted) by

the trauma and moral injury. The concepts of God’s sovereignty and a discrepancy

between God’s character and one’s lived experience are introduced. Also discussed are

the limits to one’s moral agency, power, and responsibility. Active surrender is

introduced as a tool that can be used to help resolve or accept potential discrepancies and

inflated or distorted beliefs in this area. Scriptures on power/control are also shared with

patients (verse on only God being God). For homework, patients read the power/control

module in the patient workbook and complete worksheets on this topic related to God,

self, and others. They will also continue to engage in penance and confess verses on

God’s power and control/surrendering to God.

17

CCPT Session 10: Begins with a review of the Power/Control worksheets. The topic of

esteem (self-esteem and regard for others) is introduced, followed by a discussion on how

esteem can be disrupted by traumatic events. For homework, patients read the esteem

module and complete worksheets on this topic related to self and others. Patients are also

asked to practice giving and receiving compliments during the week and doing at least

one nice thing for themselves each day.

RCPT Session 10: Begins with a review of the Power/Control worksheets. The topic of

self-empathy and other-focused empathy inspired by God’s love is introduced, followed

by a discussion on how empathy can be disrupted by traumatic events. Post traumatic

growth, including spiritual growth, is introduced from a religious perspective. Biblical

examples of people who grew through trauma and challenges are provided and discussed.

For homework, patients read the empathy module and complete worksheets on this topic

related to God, self, and others. Patients are given scriptures based on God’s love and

affirmations to meditate upon. They will also be asked to practice giving and receiving

compliments during the week and identifying at least one positive way they have grown

through this experience. They will also continue to engage in penance.

CCPT Session 11: Begins with a review of the homework. The topic of intimacy is

introduced and how relationships may have been impacted by the traumatic incident is

discussed. For homework, patients complete worksheets on intimacy related to self and

others, and continue to work on stuck points from previous topics that remain

problematic. Finally, patients are asked to rewrite the impact statement from session one.

RCPT Session 11: Begins with a review of the homework. The topic of intimacy is

introduced and discussed is how relationships, including a relationship with God, may

have been impacted by the traumatic incident. The account of Judas and Peter’s moral

injury and subsequent actions will be contrasted. Also discussed are ways to move toward

God and others in the patients’ religious community (e.g., through altruism, compassion,

prayer, social support). For homework, patients complete worksheets on intimacy related

to God, self, and others. Patients will also be provided scriptures related to intimacy to

meditate upon, will engage in penance, and will take one step toward greater intimacy

with someone in their religious community. Finally, patients are asked to write a

statement in which they look for positive growth and how they intend to live going

forward transformed rather than deformed by the moral injury and God’s healing power.

CCPT Session 12: Begins by reviewing the homework. Patients are asked to read the

new impact statement and then compare it to the original impact statement. Changes and

growth are discussed. The rest of the session is spent reviewing the course of treatment,

identifying any remaining issues that need further attention, and setting future goals.

RCPT Session 12: Begins by reviewing the homework. Patients are asked to read the

new impact statement and compare it to the original impact statement. Changes and

growth are discussed, particularly as they relate to trauma/moral injury and spiritual well-

being. Patients are encouraged to create a “Clean Monday,” which is the day after Lent in

which people fly kites to celebrate the resurrection and new life. The rest of the session

is spent reviewing the course of treatment, identifying any remaining issues that need

further attention, discussing hope, and setting future goals.

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Interfaith Panel

Faculty psychotherapists (PhD or MD) experienced with cognitive therapy and

with integrating religious beliefs into therapy from Christian, Jewish, Muslim, Buddhist,

and Hindu perspectives will form an interfaith panel. They will assist in the development

of the four non-Christian versions of the religiously-integrated CPT manual and

workbooks, and will help to supervise therapists if a subject from their faith tradition is

enrolled into the study.

Therapists

Licensed counselors (at the master’s degree level) will administer twelve 50 min

sessions of CPT in-person over 6 weeks.1 We have compressed the sessions which are

usually provided over 12 weeks to 6 weeks, since our previous clinical trial found that

most improvement occurs within the first 4 weeks of treatment.151

Six community-based

counselors will be hired from outside the military by Duke to administer the interventions

(two therapists for each site). CPT and RCPT therapists will be trained onsite for the trial

and supervised by telephone throughout the trial by Duke Faculty skilled in CPT

(O’Garo) and religious CBT (Pearce).

To qualify as a study therapist, a score of 40 or higher based on ratings by

supervising faculty on recordings of therapy delivered will be required on the Cognitive

Therapy Rating Scale (CTRS), a measure of therapy competence that we will adapt for

CPT.152,153

Treatment adherence will be assessed using an adapted version of the

Adherence Rating Scale (ARS), which assesses adherence to session structure (range 0-

15), development of the therapeutic relationship (range 0-6), adherence to the manual

(range 0-8), therapist competence (range 1-4), and flexibility (range 1-4).154

A 10%

random sample of sessions will be tape recorded (n=300), of which 50% will be

randomly selected (n=150 or 25 per therapist), transcribed, and rated by trained and

supervised raters otherwise not directly involved in the study. The tape recorded sessions

will be weighted towards the beginning of the study so that corrective actions may be

taken early on if there are problems with adherence.

Therapists will be paid $75 for each 50-minute session completed and receive a

flat fee of $1,000 at the end of the study for time spent during training and supervision

sessions.

Treatment Attrition

Dropout rates prior to completing the full course of religiously-integrated

therapies (and control therapies) have been reported to range from less than 10% to up to

40%.155,156

We are projecting a dropout rate of 25% for the present study, which is

reasonable given this military population with multiple comorbidities including substance

abuse.

MEASURES

1 At first thought to include PhD/PsyD as therapists. However, think it might be better to use master’s level

counselors for the clinical trial to determine treatment efficacy (RCPT superior over CCPT). However, the

ultimate plan is to train master’s level military chaplains and VA chaplains to administer religiously-

integrated CPT in their respective settings, given their background, expertise, and responsibility in

addressing moral injury and religious struggles. Currently, chaplains do not provide CPT.

19

Demographic Factors

Demographics assessed will be age, gender, race/ethnicity, education, marital

status, living situation, and number of children. Information about current and past

military service will also be collected, including branch of service, time in the military,

current status (active duty vs. retired veteran), type and length of previous deployments,

time since last deployment, and time since primary traumatic experience (Criterion A).

PTSD Diagnosis and Severity

PTSD Diagnosis. The diagnosis of PTSD will be made using the latest version of

the Structured Clinical Interview for DSM-5 Disorders - Clinical Trials version (SCID5-

CT) that assesses the current criteria for the diagnosis of PTSD.157

In DSM-IV, Criterion

A required that the person be exposed to a traumatic event in which (1) the person

experienced, witnessed, or was confronted with an event or events that involved actual or

threatened death or serious injury, or a threat to the physical integrity of self or others,

and (2) the person’s response involved intense fear, helplessness, or horror.158

With DSM-5, the diagnostic criteria for PTSD underwent substantial revision,

including criterion A.159

PTSD was moved out of the category of anxiety disorders and

into a new chapter dedicated to Trauma- and Stressor-Related Disorders (one that now

includes adjustment disorder). Criterion A was revised, three additional symptoms were

added (increasing the number from 17 to 20), and the avoidance cluster was divided into

avoidance and negative alterations in cognitions and mood. Criterion A now requires that

the person be exposed to death, threatened death, actual or threatened serious injury, or

actual or threatened sexual violence, as follows (one required): (1) direct exposure; (2)

witnessing, in person; (3) indirectly, by learning that a close relative or close friend was

exposed to trauma, where if the event involved actual or threatened death, it must be

violent or accidental; or (4) repeated or extreme indirect exposure to aversive details of

the events(s), usually in the course of professional duties (not including indirect non-

professional exposure through electronic media, television, movies, or pictures).

In DSM-5, “subthreshold PTSD” is included in a section titled Other Specified

Trauma/Stressor-Related Disorder (309.89), which includes adjustment disorders due to

trauma/stress with a duration of more than 6 months without a prolonged duration

stressor. As noted above, subthreshold disorders are more common than full PTSD and

these symptoms are associated with substantial clinical impairment.160

In a recent WHO

study of subthreshold PTSD, investigators recommended that subthreshold DSM-5 PTSD

is most usefully defined as meeting two or three of DSM-5 criteria B-E (along with

criterion A).161

These criteria will be used in the present study.

To limit the length of assessment, only the PTSD, mood disorders, anxiety

disorders, and substance abuse disorders sections of the SCID-5 will be administered.1

PTSD Symptom Severity. The severity of PTSD symptoms among members of

the military has historically been assessed using the 17-item National Center for PTSD

Checklist of the Department of Veterans Affairs (PCL).162,163,164,165

The PTSD Checklist

1 An alternative measure for documenting PTSD is the CAPS (Clinician Assessment of PTSD Symptoms),

which can be administered by trained lay interviewers. The downside is that we also need a diagnostic

measure for psychiatric co-morbidity, i.e., depressive disorder, anxiety disorder, substance abuse disorder,

which CAPS does not assess. So, it may simply be easier to use a single diagnostic instrument, the SCID-

5.

20

assesses the symptoms of PTSD as required for a diagnosis of PTSD in DSM-IV-TR.

Participants are asked, “How much have you been bothered by each problem in the past

month.” Possible response options are 1 (“not at all”), 2 (“a little bit”), 3 (“moderately”),

4 (“quite a bit”), and 5 (“extremely”). Responses are summed to create a PTSD severity

scale that ranges from 17 to 85. A PCL cutoff of 50 or higher is usually used and

considered a sensitive and specific indicator of PTSD.166,167

However, recent work

suggests that a cutoff of 44 displays good specificity (96%) while maintaining acceptable

sensitivity (72%) for PTSD in an active military population and decreasing the cutoff to

40 does not have a major impact on sensitivity and specificity.168

The PCL-5 (based on DSM-5) is the latest revision of the PCL-S (stressor

version) that is based on the new criteria.169,170

In the latest research, the 20-item PCL-5

has been found to have high agreement with the 17-item PCL-S (kappa=0.67), and both

measures show identical reliabilities and nearly identical associations with combat

exposure, major depression, generalized anxiety disorder, alcohol abuse, and functional

impairment in soldiers.171

In that study, which involved 1707 active duty U.S. soldiers,172

a cutoff on the PCL-5 of > 15 yielded a prevalence of 30% for PTSD. At a cutoff of >28,

the prevalence was 16%. At a cutoff of >32, prevalence was 14%. And at a cutoff of

>38, the prevalence was 10%. A cutoff of > 38 is equivalent to cutoff of >50 on PCL-S

(old criteria). As noted above, using a cutoff of 15 on the PCL-5, 30% met criteria for

PTSD (24% of the sample met both DSM-IV-TR and DSM-5 criteria, 5% met only

DSM-IV-TR and 5% met only DSM-5 criteria). At a cutoff of 32 on the PCL-5, 14%

met criteria for PTSD (11% met both DSM-IV-TR and DSM-5 criteria, 3% met only

DSM-IV-TR and 3% met only DSM-5 criteria). Among soldiers deployed to Afganistan

or Iraq, 24% scored 27 or higher on the PCL-5, which is equivalent to a PCL-S score of

40 or higher (kappa=0.73); 19% met both DSM-IV-TR and DSM-5 criteria, 5% met

DSM-IV-TR only, and 5% met DSM-5 criteria only.173

Given that we would like to include soldiers and veterans with subthreshold

PTSD, we will use the PCL-5 cutoff of 27 or higher (equivalent to a PCL-S cutoff of 40

or higher) to identify soldiers and veterans for entry into the study. This means that if

estimates of PTSD are similar to those found by Hoge and colleagues above, then 16% of

all soldiers and 24% of all deployed soldiers would meet PCL-5 or DSM-5 criteria for

PTSD. Unfortunately, comparable data for veterans is not yet available.

Exposure to Trauma

The Combat Experiences Scale (CES) will be administered at baseline to gauge

soldiers’/veterans’ exposure to combat-related activities, such as taking fire, firing

weapons, and perceived threat of injury or death.174

This 7-item measure is widely used

to assess combat stressors. Each item is scored on a 5-point scale from 1 (never) to 5

(many times), with higher scores indicating greater exposure to combat-related stressors.

The CES will be compared between treatment groups at baseline and if differences are

found, will be controlled for in statistical analyses.

Co-morbid Physical Illness

Physical and Cognitive Functioning. Baseline physical functioning will be

measured using the 10-item subscale from the SF-36 (possible score range 10-30, with

higher scores indicating better functioning).175

Since a major aspect of the treatment in

21

the proposed study involves “cognitive therapy” and much of the data gathered is by self-

report, measurement of cognitive function is vital. The Brief Mini-Mental State Exam

(BMMSE)176

is an 18-item version of the standard 30-item cognitive screening

instrument. Patients scoring 13 or lower on the BMMSE are considered significantly

cognitively impaired (an exclusion criterion).

Medical Co-Morbidity. The Charlson Comorbidity Index identifies, classifies,

and assigns comorbidity scores to 31 medical illnesses based on ICD-9 criteria.177

This

measure will be supplemented by asking about the presence of other physical health

conditions lasting or projected to last 3 months or longer including chronic pain,

amputations, fractures, closed-head trauma (TBI), open cranial trauma, chest trauma,

ocular injury, spinal cord injury, and muscle, nerve, vascular injuries caused by shrapnel

or gunshot wounds, cardiovascular disorder, or any other physical health condition

related to trauma resulting from serving in a combat or war theatre (including short-term

and long-term health consequences). This expanded measure will also be used to

determine whether a physical illness is co-mobid with PTSD (an inclusion criterion).

Co-morbid Psychiatric Symptoms

Depression and Anxiety. The SCID-5 will be used to diagnose depression and

anxiety disorders at baseline. Because of its brevity, the Hospital Anxiety and

Depression Scale (HADS) will be used to assess depression and anxiety symptoms on

follow-up.178

This 14-item scale includes 7 items that assess anxiety and 7 items that

assess depression. The scale is widely used in persons with physical health problems,

and focuses more on cognitive symptoms rather than biological ones. Patients with

somatic complaints can spuriously inflate scores on depression measures - despite not

being depressed or anxious, per se. The psychometric properties of the scale indicate

high internal reliability (Cronbach’s alpha 0.85 for anxiety subscale and 0.84 for

depression subscale, overall 0.89), and reveal a 2-factor solution as predicted based on

theoretical grounds.179

Substance Abuse. Substance use and abuse will be assessed at baseline by the

SCID-5, and symptoms will be tracked over time using the Alcohol, Smoking, and

Substance Involvement Screening Test (ASSIST).180

The ASSIST is an 8-section

questionnaire developed by an international group of substance abuse researchers for the

World Health Organization. The ASSIST provides information about: (1) the substances

people have ever used in their lifetime; (2) the substances they have used in the past three

months; (3) urge to use substances; (4 and 5) problems related to substance use; (6 and 7)

level of dependence; and (8) injecting drug use. There are 10 questions per sections 1-7

and 1 question per section 8 for a total of 10 to 71 questions, depending on responses.

Substances addressed include: tobacco, alcohol, cannabis, cocaine, amphetamine type

stimulants, sedatives, hallucinogens, inhalants, opioids, and other drugs. The ASSIST

has been used in many studies to assess degree of substance use and its psychometric

properties are well-established.181,182

Since we are primarily interested in current use,

questions will be modified to assess use within the past 4 weeks.

Most CPT treatment protocols recommend that substance abuse is treated prior to

implementing CPT; however, since this treatment protocol is translational in nature, and

seeking to determine effects in “real world” situations (an effectiveness study), active

substance abuse is not an exclusion criterion although will be carefully measured.

22

Sleep Quality

Sleep quality will be assessed at baseline and follow-up with the 19-item

Pittsburgh Sleep Quality Index (PSQI).183

The PSQI is a self-rated measure of sleep

quality and disturbances over the past month. Responses to items on the scale generate

seven “component” scores: subjective sleep quality, sleep latency, sleep duration,

habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime

dysfunction. The seven component scores are summed to yield a global score of sleep

quality with a range from 0-21 (individual component scores range from 0-3). The

Cronbach’s alpha is 0.83 and the test-retest reliability is r=0.85. A cutoff score of >5 has

a 90% sensitivity and 87% specificity in distinguishing poor sleepers from good sleepers

(kappa=0.75).

Guilt and Shame

Guilt and shame are known to be key factors that drive PTSD symptoms and may

underlie moral injury. The 16-item Guilt and Shame proneness Scale (GASP) will be

used to assess these personality characteristics.184

The GASP has four 4-item subscales:

guilt negative behavior evaluation, guilt repair, shame negative self-evaluation, and

shame withdraw. Items are rated on a 7-point Likert scale from very unlikely (1) to very

likely (7), and have a total score for guilt and for shame of 7-56 each. Coefficient alphas

range from 0.61 to 0.71 for the four subscales.

Moral Injury

The Moral Injury Questionnaire (MIQ) assesses the negative consequences

associated with war-zone stressors that conflict with military veterans’ deeply held values

and beliefs.185,186,187

This 20-item scale focuses on (1) acts of betrayal by peers,

leadership, civilians or self; (2) acts of disproportionate violence inflicted on others; (3)

incidents involving death or harm to civilians; (4) violence within military ranks; (5)

inability to prevent death or suffering; and (6) ethical dilemmas or moral conflicts.

Overall scale score is highly correlated with PTSD symptoms.188

Negative Religious Coping Religious and spiritual struggles often accompany PTSD, as discussed earlier.

Religious or spiritual struggles will be measured using the 7-item negative religious

coping subscale of the Brief RCOPE.189

Each item is assessed on a range from 0 (not at

all) to 3 (a great deal) (with a total scale range from 0 to 21). This measure has been

frequently associated with higher PTSD severity scores,190,191,192

and will be a target of

religiously-integrated CPT in the proposed study, along with guilt and shame, and moral

injury.

Past Psychiatric History & Treatments

Personal & Family Psychiatric History. Prior psychiatric history, history of

depression, and family psychiatric history will be gathered using an adapted version of

the Duke Depression Evaluation Schedule.193

First, participants will be asked if they ever

in the past experienced an episode of two weeks or longer of depression or loss of interest

(yes vs. no). Second, patients will be asked if they have ever experienced a mental or

23

nervous condition that required some form of treatment (yes vs. no). Third, family

psychiatric history will be assessed by asking if any first degree relative (parents,

siblings, children, grandchildren) ever had a mental or nervous condition, ever saw a

psychiatrist or therapist, was ever admitted to a psychiatric hospital, ever took nerve

medicine for three months or more, made a suicide attempt or committed suicide, or had

a problem with drugs or alcohol (yes vs. no).

Current and past treatments for psychiatric disorder. Current and past treatments

for psychiatric disorders will be examined. The participant will be asked if he or she (1)

currently takes medication for any emotional or mental health condition (antidepressant,

anti-anxiety, anti-psychotic, other), (2) has ever taken any medication of this nature in the

past (antidepressant, anti-anxiety, anti-psychotic, other), (3) is currently receiving

counseling or psychotherapy (type of therapy and when last treatment session was

received), and (4) ever received counseling or psychotherapy in the past (and how long

ago).

Religiosity/Spirituality

Besides denomination, single items assessing self-rated religiosity (1- not at all

religious, 2-somewhat religious, 3-moderately religious, 4- very religious), self-rated

spirituality (1- not at all spiritual, 2-somewhat spiritual, 3-moderately spiritual, 4- very

spiritual), private religious practices,194

and religious attendance195

will be administered,

along with multi-item measures of daily spiritual experiences (16 iems),196

intrinsic

religiosity (10 items),197

and religious commitment (10 items).198

Each of these measures

have established psychometric properties including solid reliability and validity

indicators. Single items and multi-item scales will be combined to form a 40-item global

religiosity/spirituality measure that will be used in statistical analyses.

Positive Emotions The benefits of addressing religious beliefs in therapy may stem partly from

redirecting attention from a focus on trauma, loss and preoccupation with self to

cognitions that focus on hope, purpose and meaning in life, optimism, and post-traumatic

growth, which have been shown to predict better mental health and fewer clinical

symptoms.199,200,201,202,203

Validated scales will be used to assess each of these positive

emotions both at baseline and during follow-up evaluations to assess change over time in

response to treatment and their relationship with PTSD symptom severity.

Hope. The 6-item State Hope Scale (SHS) will be used to assess this construct.204

The SHS has a two-factor structure (agency and pathway) with each factor consisting of

three items; and the factor structure has been confirmed in a separate study.205

The

internal consistency of the SHS is high (alpha=0.93), as well as the test-retest reliability

(range 0.48-0.93). Hope has been shown to mediate the effects of CPT on PTSD.206

Purpose in Life. The 20-item Purpose in Life (PIL) Scale assesses PIL based on

theories about positive psychological health and lifespan development.207

Each item is

rated on a 7-point scale and the total PIL score ranges from 20 to 140.208

High scores on

the PIL scale indicate that participants have goals and a sense of direction in life, feel that

there is meaning to their lives both currently and in the past, hold beliefs that give life

purpose, and have aims and objectives for living; low scores reflect lack of meaning or

direction in life, few goals, and inability to see purpose in past events.209

The reliability

24

and validity of the PIL scale has been established in numerous studies. 210,211,212

The

measure has been shown to have good split-half and test-retest reliability.213,214

The PIL

scale had a Cronbach’s alpha of 0.91 in the original study,215

and there is evidence for

both convergent and discriminant validity.216

Optimism. The Life Orientation Test-Revised (LOT-R) is a 10-item measure of

dispositional optimism developed in 1985 by Scheier and Carver217

and revised in

1994.218

This measure is the most common instrument used to assess optimism, and has

been administered extensively in psychological research over the past 30 years.219

The

LOT-R predicts medical outcomes in persons with physical illness, independent of

depression and personality traits.220

The 10 items are scored on a scale from strongly

disagree (0) to strongly agree (4) (overall range 0-40).

Self-esteem. Self-esteem is being measured using the 10-item Rosenberg Self-

Esteem Scale (SES), which is the standard measure in the field.221

The SES measures

global self-worth by assessing both positive and negative feelings about the self. All

items are answered on a 4-point scale from strongly agree (1) to strongly disagree (4).

Score range is 10-40. In the validation study involving a community sample of 503

adults, reliability (Cronbach’s alpha) was 0.91.222

Post-Traumatic Growth. PTG will be assessed using the 10-item PTGI-SF

scale,223

which assesses positive psychological changes as a result of struggling with life

stressors. After designating their “worst” stressful event respondents are asked to rate

items such as “I changed my priorities about what is important in life” on a scale from 0

(did not experience) to 5 (a very great degree). Scores range from 0 to 50 and higher

scores indicate the degree of positive psychological change as a result of the negative life

event. Internal consistency of overall scale is high (α= 0.95), and consists of five

subscales that also have high reliability alphas: development of more intimate

relationships (α= 0.84), recognition of new possibilities or paths for one’s life (α=0.85),

greater sense of personal strength (α= 0.89), greater spiritual development (α=0.92),

greater appreciation of life (α=0.80).

Social Support

Perceptions of social support and degree of social engagement are known to be

affected by PTSD and influence recovery from PTSD. Social support will be measured

with the social interaction and subjective support subscales of the Duke Social Support

Index.224

This 11-item brief version of the DSSI asks about time spent interacting with

friends, neighbors, and family, both in person and on the telephone, and also assesses the

subject’s satisfaction with social interactions and support received. The brief DSSI has

been validated in adults with chronic health problems, and has a score range of 11 to

33.225

Assessments and Procedures

Screening, baseline assessment and follow-up assessments are described below.

Screening Assessment. The screening evaluation, which will usually take place

by telephone, will include an initial explanation of the study and determination of

whether initial eligibility criteria are met (15 min).

Is an active duty soldier or veteran

Has or had a diagnosis or symptoms of PTSD

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Has comorbid physical illness or injury

Has sleep problems

Religion at least somewhat important

English-speaking

Willing to participate in a psychotherapy study involving 12 treatment sessions

twice weekly over 6 weeks and completing assessments at 3, 6, 12 and 24 months

No severe cognitive impairment

No Cognitive Processing Therapy within past 4 weeks

If initial telephone screen is passed, participants will be scheduled for an in-person

screening evaluation. At that time, the study will be more fully explained and written

consent to participate will be obtained. The screening process will be completed at this

time. The in-person screening evaluation will consist of the following (30-45 min):

Review responses to initial telephone screen to ensure initial eligibility

Brief Mini-Mental State Exam (12 items)

PCL-5 (20 items)

SCID-5 (PTSD, mood disorders, anxiety disorders, substance abuse sections only)

Self-rated religiosity and spirituality (2 items)

Charlson Comorbidity Scale (31 items)

Baseline Evaluation. If participant is eligible, study personnel will explain the study

again to the participant and what is expected, and will then perform the baseline

evaluation (45-60 min):

Demographics (12 items)

Combat Experiences Scale (7 items)

Physical functioning from SF-36 (10 items)

Hospital Anxiety and Depression Scale (14 items)

ASSIST (10 to 71 items, depending on response)

Pittsburgh Sleep Quality Index (19 items)

GASP (guilt and shame) (16 items)

Moral Injury Questionnaire (20 items)

Negative religious coping (7 items)

Personal/family psychiatric history (3 items)

Current/past treatments for psychiatric disorder (10 items)

Religiosity/spirituality (40 items)

State Hope Scale (6 items)

Purpose in Life Test (20 items)

Life Orientation Test (optimism) (10 items)

Self-esteem (10 items)

Post-traumatic Growth (10 items)

Brief Duke Social Support Index (11 items)

26

Follow-up Evaluations. Participants will be reassessed by research coordinators

(blind to treatment group) at 3 weeks, 6 weeks, 12 weeks, and 24 weeks after the baseline

evaluation either in-person or by telephone (60 min):

PCL-5 (20 items)

Hospital Depression and Anxiety Scale (14 items)

ASSIST (10 to 71 items, depending on response)

Pittsburgh Sleep Quality Index (19 items)

Current treatments (only at 6 weeks and 24 weeks) (2 items)

Physical functioning from SF-36 (10 items)

Religious commitment (10 items)

Moral Injury Questionnaire (20 items)

Negative religious coping scale (7 items)

State Hope Scale (6 items)

Purpose in Life Test (20 items)

Life Orientation Test (10 items)

Brief Duke Social Support Index (11 items)

Post-traumatic Growth (10 items)

GASP (guilt and shame) (16 items)

Self-esteem (10 items)

Response Burden and Subject Payments

We anticipate that the initial interview may last as long as 90 minutes and follow-

up interviews as long as 60 minutes. In order to minimize response burden, we have

limited the number of measures and use abbreviated measures of constructs whenever

possible. Our research coordinators will have to be carefully selected so that they can

keep the participant’s attention and manage the participant’s frustration level during the

assessments.

We will pay participants $25 for in-person screening/baseline evaluation and $25

per follow-up assessment after they complete the study ($125 total). Active military

personnel can only be paid if the activity takes place outside of normal work hours

(7:30A-4:30P on weekdays); veterans can be paid regardless of when the interview is

done.

Statistical Analyses

Both primary and secondary endpoints will be analyzed using the intention-to-

treat (ITT) principle, except for per-protocol analyses (see below). Power analyses

indicate that a sample size of 300 participants will be adequate to identify a significant

difference between treatment groups in order to test our primary hypothesis (1.1).

Anticipating a 25% dropout rate, a final sample of 226 soldiers/veterans, 113 in each

intervention arm, will produce a greater than 80% power to detect a small to moderate

difference between groups (Cohen’s d=0.38) at a p value of 0.05 (2-tailed test) for the

primary outcome (PTSD symptom severity on the PCL-5) assessed at 6-weeks from

baseline at the end of treatment. For descriptive purposes only, we will compare PCL-5

scores between treatment groups at baseline, 3 weeks, 6 weeks, 12 weeks, and 24 weeks

27

to determine visually whether there are any differences in effects of RCPT vs. CPT on

PTSD symptom severity.

Primary Analysis: To test Hypothesis #1.1, we will use growth curve analyses

using random intercept and slope to examine trajectories of change in PCL-5 scores

between the two treatment arms through 6 weeks (taking into account PCL-5 scores at 0,

3, and 6 weeks) (Model 1).1 This will allow participants with data for at least one time

point to be included in the analysis and help to address the problem of missing data. The

model will include the fixed effects of treatment group, time, time squared (if

significant), and the interaction of treatment group with time. Military type (active duty

soldiers vs. veterans), PTSD type (subthreshold vs. standard PTSD), and psychiatric co-

morbidity (present vs. absent) will be examined in these models to determine their effects

on treatment outcome (if there are baseline differences not addressed by randomization).

Secondary Analyses: To test Hypothesis #1.2 (persistence of effects), we will

compare the effects of RCPT vs. CPT through 24 weeks by including PCL-5 severity

score at 24 weeks in Model 1 (Model 2). To test Hypothesis #2, we will develop growth

curve models comparable to Models 1 and 2 with depressive symptoms, anxiety

symptoms, substance use, and sleep quality as primary outcomes. To test Hypothesis #3,

we will include hope, purpose in life, optimism, post-traumatic growth, self-esteem,

social support, guilt/shame, and negative religious coping scores one at a time and then

all together in growth curve Models 1 and 2 to determine if these factors explain the

benefit of RCPT over CPT on PTSD severity and co-morbid mental and sleep problems

(if there is a benefit). Hypothesis #4 will be tested by developing growth curve models

comparable to Models 1 and 2 with moral injury as the outcome, rather than PTSD

symptoms, mental, or sleep quality. To test Hypothesis #5 (moderating effects of

religiosity, where moderation refers to a change in slope in one group but not the other),

we will examine the interaction between treatment group and overall religiosity. This

will be done by entering the summed measure of religiosity into the growth curve models

(Model 1 and Model 2) along with the interaction between religiosity and treatment

group. If the interaction is significant, then we will examine the effect of RCPT vs. CPT

on PTSD severity in those with high vs. low religiosity. The summed religiosity variable

will be dichotomized into those scoring one-half standard deviation above the mean or

higher (high religiosity) vs. others (low religiosity), and models run in each category.

Secondary analyses will include repeating the above analyses per-protocol, i.e., including

only participants who have completed at least 6 of the 12 treatment sessions.

Effect sizes (Cohen’s d) will be determined using t-statistic values and degrees of

freedom from growth curve models. All statistical analyses will be done using SAS

(version 9.3; SAS Institute Inc., Cary, North Carolina). The significance level will be set

at p=0.05 for testing the primary hypothesis above (1.1) and at p=0.01 for secondary

analyses, a more conservative value given the multiple statistical tests performed (but

short of the too conservative Bonferroni correction for these exploratory analyses).

1 We considered using repeated measures ANOVA or ANCOVA, with between and within subject

comparisons and if significant, post-hoc t-tests, although this would require adjusting the analysis of the

primary hypothesis for multiple tests. This was a primary reason for deciding on a single growth curve

model.

28

HUMAN SUBJECTS CONSIDERATIONS

We will obtain full IRB approval for the study from Eisenhower Army Medical

Center (EAMC) as the primary site, which will be handled by Scott Mooney, the site PI

there. We will then seek a Memorandum of Understanding for Womack Army Medical

Center (WAMC), with WAMC recognizing EAMC as parent IRB of record and WAMC as

a sister site. Afterwards, WAMC will complete an abbreviated site-specific addendum

showing how the parent protocol will be carried out there. WAMC will complete an

abbreviated site-specific addendum showing how the parent protocol will be carried out

there. Full IRB approval is likely to be necessary at the VAMC in Augusta and Duke as

well.

This human subjects’ research meets the definition of ‘Clinical Research’. The risks

associated with this study are the risks involved the loss of confidentiality and the possible

worsening PTSD with adverse psychological consequences that may follow. All records

will be kept confidential to the extent permitted by law. Patient identifying information will

not be transmitted to or databased in RedCap (i.e., it will be de-identified). Access to such

information will be allowed only to certain authorized members of the research team,

institutional staff, and regulatory agencies. In reporting the results, privacy will be protected

by using a coding system that does not reveal the identity of individuals, and by reporting

group results.

Recruitment and Consent Procedures

The recruitment procedures for our study will include a thorough explanation of

the study, time commitment, possible risks and benefits, and alternatives for treatment.

Participants will be informed about the purposes of the research study. Specifically, they

will be informed about the diagnosis of PTSD and its treatment. Through a combination

of written materials and the consent form, they will be told that this is a treatment study,

and each of the two study arms will be described. They will be informed that there is an

equal chance (random assignment) to be assigned to one or the other of the two study

arms. Details of the study will be explained, as well as the differences between early

termination and dropping out and the consequences of each. They will be further

informed that their identity will be kept confidential through the use of a confidential

code number that will allow all information to be entered into the database in an

anonymous fashion, such that information cannot be linked or traced to any person

outside of the immediate investigative team. Aside from treatment planning, all

information will be used only for group statistical analyses. All study participants will be

told the expected duration of the study and informed that subjects' consent can be

withdrawn at any time, at no risk to having other treatment in their clinical setting

withheld. Alternatives to participation will also be noted in the consent form.

Risks to Subjects

This investigation will be conducted with prior approval from DUMC, EAMC,

CN-VAMC, and WAMC Institutional Review Boards (IRBs). Details of how potential

subjects will be ascertained and recruited for study participation, and how their rights and

welfare will be protected, will be provided to these IRB’s.

Risk to Confidentiality. Personal identifying information, such as name, address,

driver’s permit, Social Security Number, etc., will not be entered into the database.

29

However, other identifying data fields, including date of birth, treatment group, and

questionnaire data will be recorded on the case report forms and entered directly into

RedCap, the secure database used for all Duke University studies. The control of access

to the database will be managed centrally by the CTCC through user passwords linked to

appropriate access privileges. This protects forms from unauthorized view and

modification and from inadvertent loss or damage. Database servers are secured by a

firewall as well as through controlled physical access.

Miscellaneous Risks. If at any time a study interviewer or study therapist believes

that there is a significant risk of harm with a subject who is participating in the study (i.e.,

getting upset, expressing suicidal thoughts, etc.), he or she will consult with the study site

PI (a psychologist or psychiatrist). This person will then assess the patient. If they

believe there is a significant risk, then they will immediately do whatever is necessary to

ensure the safety of the subject.

Potential Benefits to Participants and Others

The benefits to participants in this study are that they will receive free psychotherapy

for their PTSD from licensed therapists trained in CPT and supervised by Duke faculty

experienced in delivering CPT. The benefits to others will result from our learning whether

integrating patients’ religious beliefs/practices into CPT will result in faster and more

complete remission of PTSD than that achieved with conventional CPT that does not

typically utilize patients’ religious resources in therapy.

Premature Withdrawal, End-of-Study Debriefing, and Referral Options

All prematurely terminating subjects will be asked to complete the full assessment

batteries. Some patients may exhibit transient worsening at an assessment point, but in

the judgment of the therapist and supervisor (and study psychologist, as necessary)

warrant continuation in the study. Should severe worsening occur, then subjects will be

withdrawn from the study. There are no procedures for maintenance of treatment

following premature withdrawal from the study or at the end of the 12 treatment sessions.

Hence, ethical principles require that at study withdrawal or end of the treatment period,

all participants be given recommendations for any indicated further treatment and

appropriate referrals. To standardize this process across therapists, we will use a

standardized debriefing script. Briefly, this script will a) provide the subject a chance to

state any concerns or questions they have; b) provide a summary of progress using

clinical indicators; c) outline the possible available treatments; and d) make

recommendations about appropriate continuing treatment. All subjects needing or

requesting further treatment will be given a list of possible providers for the

recommended treatment and will be told that a clinical report could be sent with the

subject’s authorization to any new treatment provider(s).

Subject Safety and Adverse Events Reporting

An adverse event (AE) is any untoward, undesired, or unplanned event in the

form of signs, symptoms, disease, or laboratory or physiologic observations occurring in

a person in a research study. The event does not need to be causally related to the

research study. Site PIs will record all AEs and serious adverse events (SAE) on source

documents and data forms, as well as complete appropriate adverse event reporting forms

30

and forward to the Clinical Trials Control Center (CTCC) within the required time frame

for reporting, but in no case beyond these time frames. SAEs will be reported to the

CTCC within 24 hours of occurrence via fax or e-mail with a written report submitted

within seven (7) calendar days. The site PIs will follow up on all AEs and SAEs until the

events have subsided or until the condition has stabilized. The CTCC will maintain

detailed records of all AEs and SAEs reported by the site PI’s in accordance with good

clinical practice and applicable regulations (with oversight by Dr. Koenig).

Regular Teleconferences

Uncertainties regarding how to administer the protocols are certain to arise.

Members of the Steering Committee will engage in monthly teleconferences. Using the

teleconference mechanism, a set of precedents will be established regarding how best to

manage situations that call for screening and enrollment of subjects, and flexible

administration of the CPT protocols. In turn, this set of precedents will contribute to the

development of a common culture, which will insure that screening procedures and

assessments are administered in the same fashion by therapists, and CPT supervisor/s are

training and supervising therapists in a similar fashion.

Timeline

Considering a startup and training period of 3 months, a recruitment phase of 24-

30 months, and 3-9 months to clean the data and write the papers at the end of the trial,

we anticipate a 3-year project (ideally, January 1, 2016-December 31, 2018).

Budget and Budget Justification

Personnel: Duke University Medical Center

Harold G. Koenig, M.D. Dr. Koenig will serve as the Lead/Coordinating

Principal Investigator (Lead PI), will draft the protocol(s), identify team members, assist

with the hiring of interviewers, assist with the training of interviewers and therapists,

preside over steering committee meetings, monitor recruitment at each of the three sites,

ensure that study goals are met, assist with statistical analyses, and provide first drafts of

papers coming from this project. These responsibilities will require 35% effort (FTE)

over the 3 years of the project; of this, he will match 10% and request 25% per year from

the grant: $118,278 x 25% x 3 = $88,789.

Keisha-Gaye N. O'Garo, Psy.D., ABPP. Dr. O’Garo (co-investigator) is a skilled

practitioner of Cognitive Processing Therapy (CPT), is on the faculty at DUMC in

psychology, and has worked for years treating soldiers with PTSD at Womack Army

Medical Center (WAMC), Fort Bragg. She will assist Dr. Pearce in developing

religiously-integrated CPT, including the treatment manuals for the 5 religious faiths and

the treatment workbooks for therapists and patients. She will also lead the training of the

6 therapists for the study and serve as supervisor during the trial, along with Dr. Pearce.

She will serve as the primary monitor of recruitment at the WAMC site, will form the

research team there, including identification of a local/site PI, site coordinator

(recruiter/interviewer), and therapists. She will also serve on the steering committee and

assist in the writing of the papers from the study. These duties will take 30% effort

(FTE) over the 3 years of the project, which we are requesting: $150,000 x 30% x 3 =

$135,000.

31

Michelle Pearce, Ph.D. Dr. Pearce (co-investigator) is a skilled practitioner of

Cognitive Behavioral Therapy (CBT), developed the religiously-integrated CBT

intervention used in our recent clinical trial, and trained and supervised the therapists who

delivered it. She has extensive experience in cognitive therapies. Previously on the

faculty at Duke in medical psychology, she is now an adjunct professor at Duke and

professor at the University of Maryland School of Medicine. She will work with Dr.

O’Garo to develop the religiously-integrated CPT, and train, supervise, and help identify

the study therapists. She will also serve on the steering committee and assist in the

writing of the papers from the study. These duties will take 20% effort (FTE) over 3

years of the project, which we are requesting: $150,000 x 20% x 3 = $90,000.

Clinical Trials Coordinator (TBD). This person (master’s degree of higher) will

be in charge of the Clinical Trials Control Center (CTCC), and be responsible for

randomizing subjects to treatment groups and therapists, connecting subjects to their

therapists, working with each of the three research coordinators to schedule and track

baseline and follow-up assessments, working with each of the six therapists to schedule

and track therapy visits, and dealing with any database (Redcap) issues related to

acquiring data from the site research coordinators. This person will also arrange to have

150 therapist sessions randomly identified and those sessions recorded and transcribed,

and then entered into the Redcap system. This person will need extensive experience as a

clinical trials coordinator. These responsibilities will take 50% effort FTE, and we are

requesting: $80,000 x 50% x 3=$120,000.

Interfaith Panel. The interfaith panel consists of mental health professionals (at

MD or PhD level) who are experts on integrating religion into psychotherapy from

Jewish, Hindu, Buddhist, and Muslim perspectives. They will assist in the development

of the non-Christian CPT manuals and workbooks, and in the supervision of therapists

who provide treatment to subjects from those traditions when enrolled in the study. We

are requesting $3,000 for each member of the panel, or $12,000 total.

Business Office (Judi Miller). This individual will be in charge of preparing the

paperwork for the grant submission, developing contracts with the funding agencies,

developing subcontracts with the three recruitment sites, arranging payment of all

personnel outside of Duke, and monitoring the budget and expenses. These duties will

take 25% effort (FTE) over 3 years of the project, which we are requesting: $60,000 x

25% x 3 = $45,000.

Statistician (TBD). Will oversee data management and will perform with Dr.

Koenig all of the statistical analyses for this project and participate in the papers that

result. These duties will take 10% effort (FTE) over 3 years of the project, which we are

requesting: $150,000 x 10% x 3 = $45,000.

Data Management (TBD). Will be in charge of data management, including all

information collected at the three sites. This includes monitoring data collection

throughout the trial to ensure that data is complete, and after the trial is completed,

preparing the data for statistical analyses. These duties will take 10% effort (FTE) over 3

years of the project, which we are requesting: $75,000 x 10% x 3 = $22,500.

Therapist Payments. Therapists will be paid $75 per 50-min session, and $1000

each for time involved in initial training and supervision throughout the trial. If 300

participants complete all 12 sessions, then therapist will need to deliver 3,600 therapy

sessions during the trial. The total cost for the therapy is estimated to be $75 x 3,600 or

32

$270,000. The cost of time for training and supervision will be $1000 x 6=$6,000. Total

amount requested=$276,000.

Subject Payments. Participants will receive $25 for the screening/baseline

evaluation whether or not they qualify, and then $25 for each of the 4 follow-up

assessments (total $125). If 300 subjects participate in the trial, the cost will be 300 x

$125=$37,500; assuming 25% x 300 do not qualify during in-person screening (n=75),

this adds $1,875, for a total cost of $39,375, which is what we are requesting.

Transcript Rater. To read through and rate a transcribed 50-min therapy session

should take 1 hour each. Given that the rater (PhD level) will have to do this for 150

transcripts, this should take 150 hours at $100/hour =$15,000, which we are requesting.

Henry Jackson Foundation Administrative Costs. Since grants (or subcontracts)

cannot be accepted by military or VA institutions, the HJF will be engaged to hire

contractors (Research Coordinators and Data Technicians) to work at EAMC, WAMC,

and the Augusta VAMC. For hiring and managing these personnel, we estimate a charge

of $135,000 (15% of salary and fringe for hired personnel).

Non-Personnel Costs

Supplies. Supplies include paper, Xeroxing, computer supplies, conference call

charges, open access journal fees, and so forth. $1500 per year for the Duke site (which

will be paying for conference calls for monthly steering committee meetings and for 1-4

times/mo supervision of therapists by their supervisors at all three recruitment sites) is

requested ($4,500 total).

Licensing costs. Wherever possible, from a cost containment standpoint, public

domain/free access tools were selected as outcome measures in the study. However, all

measures were the best available from a scientific standpoint, and some of these tools do

have a site license fee, including the SCID-5-RV, PCL-5, and several of the other

measures. The licensing fee for the SCID-5-RV from American Psychiatric Publishing is

$3,860. Other scales to be used in the study also have licensing fees and we anticipate

that $5,000 will cover the SCID-5-RV and others.

Recording and transcription costs. To assess therapist adherence to the manual

will require the recording of 150 sessions lasting 50-min each, which will then need to be

transcribed. Each of the 6 therapists will need a quality tape recorder and disks and

batteries for the recorder. We estimate the costs of these recorders and supplies will be

$200 each x 6 therapists=$1,200. Assuming each session takes 2 hours to transcribe x

150 at $35/hour=$10,500. The total cost requested, then, is $11,700.

RedCap Database. RedCap is the protected database that all information from

assessments will be entered into (via Internet), stored, and transformed into a SAS or

SPSS dataset for analysis. For programming the questionnaires into RedCap, the cost is

estimated to be $3,000.

Travel (O’Garo and Koenig). Dr. O’Garo will be traveling by car from Durham

to the WAMC in Fayetteville, NC (180 mile roundtrip), on a twice monthly basis to

monitor, train, and supervise therapists at that site, and will be flying to conduct the

training and re-training at the other two sites. Twice monthly car expenses x 30 months x

180 x 0.60/mi (projected 2016 IRS rate)=$6,480. Travel expenses for onsite visits each

year to the EAMC and CN-VAMC site (both in Augusta, GA) for both Dr. O’Garo and

Dr. Koenig will incur the following costs: flight ($400) plus 1 night hotel ($100) and 2

33

day food expenses ($100)=$600 x 2 people x 3 years = $3,600. Total requested:

$10,080.

Eisenhower Army Medical Center

Scott Mooney, Ph.D., ABPP-CN, DAC. Dr. Mooney (co-investigator) is

Researcher & Lead Neuropsychologist in Dept. of Orthopedics, Neurosciences, &

Rehabilitation at EAMC. He will serve as site PI at EAMC. His responsibilities will

include helping to draft the IRB proposal, hire and supervise the EAMC research

coordinator (interviewer/recruiter) and data technician, identify and participate in the

training of therapists for that site, and monitoring recruitment and therapist activities. He

will serve on the steering committee, and will assist with the drafting of papers that result

from the study. He will also be responsible for dealing with any administrative hurdles at

the EAMC site, including preparing the EAMC IRB proposal and WAMC site-specific

addendums (with Dr. Koenig’s assistance) and ensuring cooperation by personnel in the

PTSD outpatient and inpatient settings at EAMC and Fort Gordon where recruitment will

take place. He will also make efforts to ensure the safety of any subjects whose

emotional state deteriorates during screening or while in the study. These duties will take

20% effort (FTE) over 3 years of the project, which will be provided as matching funds

($180,000 x 20% x 3 = $108,000).

Research Coordinator (TBD). This individual (master’s degree level) will be in

charge of recruitment (screening, explaining study and administering consent), in-person

baseline and all follow-up assessments, as well as working with the Data Technician (see

below) to ensure that the data collected are accurately entered into the RedCap database.

This person will also be responsible for advertising the study, contacting potential

participants, and ensuring that recruitment stays on schedule, enrolling a minimum of 1-2

participants per week throughout the 24-month recruitment period. Given the effort

necessary to identify and recruit subjects at this site, and conduct follow-up assessments

at 3, 6, 12, and 24 weeks, this will require 100% effort (FTE) over 3 years, including

training and a buffer time towards the end of the study to ensure that recruitment goals

are met. Thus, we are requesting $75,000 x 100% x 3 = $225,000.

Data Technician (TBD). A data technician (DT) will be needed to (a) enter all

data collected into the RedCap database, and re-enter a second time for double-checking

to ensure that no data entry errors were made during the first entry; (b) help the Research

Coordinator to identify potential subjects through advertising, reviewing medical records

or other lists under the direction of the local/site PI; (c) work with the CTCC to schedule

follow-up assessments and therapist treatment sessions; (d) assist preparation of forms for

IRB submission and renewal; (e) assist the site PI with any paperwork regarding the

study and related secretarial duties; and (f) assist participants and therapists in whatever

needs they may have during the course of the study. These responsibilities will require

50% effort (FTE) over 3 years. Thus, we are requesting $50,000 x 50% x 3 = $75,000.

Miscellaneous costs. The IRB at EAMC charges a one-time fee of $3,000. To set

up an office with computer and phone setup is $2,500 and $1000/year for maintenance of

computer/phone/supplies for the project coordinator ($5,500) and $1,250 and $500/year

for maintenance of computer/phone/supplies for the data technician ($2,750). This

comes out to a total cost of $3,000 + $5,500 + $2,750 =$11,250 over 3 years, which we

are requesting.

34

Charlie Norwood VA Medical Center

Nagy Youssef, M.D. Dr. Youssef (co-investigator) is Medical Director, Acute

Inpatient Psychiatric Services at Charlie Norwood VA Medical Center in Augusta GA

(CN-VAMC), and is Clinical Assistant Professor Department of Psychiatry and Health

Behavior at the Medical College of Georgia at Georgia Regents University. He is a

physician scientist and will serve as site Co-PI at CN-VAMC. His responsibilities will

include helping to draft the proposal, hire and supervise the CN-VAMC research

coordinator (interviewer/recruiter) and data technician, identify and participate in the

training of therapists for that site, and monitoring recruitment and therapist activities. He

will serve on the steering committee, and will assist with the drafting of papers that result

from the study. He will also be responsible for dealing with any administrative hurdles at

the CN-VAMC site, including preparing the CN-VAMC IRB proposal (with Dr.

Koenig’s assistance) and ensuring cooperation by personnel in the PTSD outpatient and

inpatient settings at CN-VAMC where recruitment will take place. He will also make

efforts to ensure the safety of any subjects whose emotional state deteriorates during

screening or while in the study. These duties will take 20% effort (FTE) over 3 years of

the project, which will be $185,000 x 20% x 3 = $111,000 [salary will be divided with

other site Co-PI].

Research Coordinator (TBD). This individual (master’s degree level) will be in

charge of recruitment (screening, explaining study and administering consent), in-person

baseline and all follow-up assessments, as well as working with the Data Technician (see

below) to ensure that the data collected are accurately entered into the RedCap database.

This person will also be responsible for advertising the study, contacting potential

participants, and ensuring that recruitment stays on schedule, enrolling a minimum of 1-2

participants per week throughout the 24-month recruitment period. Given the effort

necessary to identify and recruit subjects at this site, and conduct follow-up assessments

at 3, 6, 12, and 24 weeks, this will require 100% effort (FTE) over 3 years, including

training and a buffer time towards the end of the study to ensure that recruitment goals

are met. Thus, we are requesting $75,000 x 100% x 3 = $225,000.

Data Technician (TBD). A data technician (DT) will be needed to (a) enter all

data collected into the RedCap database, and re-enter a second time for double-checking

to ensure that no data entry errors were made during the first entry; (b) help the Research

Coordinator to identify potential subjects through advertising, reviewing medical records

or other lists under the direction of the local/site PI; (c) work with the CTCC to schedule

follow-up assessments and therapist treatment sessions; (d) assist preparation of forms for

IRB submission and renewal; (e) assist the site PI with any paperwork regarding the

study and related secretarial duties; and (f) assist participants and therapists in whatever

needs they may have during the course of the study. These responsibilities will require

50% effort (FTE) over 3 years. Thus, we are requesting $50,000 x 50% x 3 = $75,000.

Miscellaneous costs. The IRB at the Augusta VA charges a one-time fee of

$3,000. For the project coordinator, to set up an office with computer and phone setup is

$2,500 and $1000/year for maintenance of computer/phone/supplies ($5,500). For the

half-time data technician, these costs will be $1,250 and $500/year for maintenance of

computer/phone/supplies ($2,750). We are also requesting miscellaneous supplies

35

(paper, Xeroxing, etc.) at $500/year. This comes out to a total cost of $3,000 + $5,500 +

$2,750 + $1500 =$12,750 total over 3 years, which we are requesting.

Womack Army Medical Center

Jay E. Earles, PsyD, ABPP. Dr. Earles is Chief of Behavioral Health at WAMC.

His responsibilities will include helping to draft the proposal, hiring and supervising the

WAMC research coordinator (interviewer/recruiter) and data technician, identifying and

participating in the training of therapists for that site, and monitoring recruitment and

therapist activities. He will serve on the steering committee, and will assist with the

drafting of papers that result from the study. He will also be responsible for dealing with

any administrative hurdles at the WAMC site, including preparing the IRB proposal (with

Dr. Koenig’s assistance) and ensuring cooperation by personnel in the PTSD outpatient

and inpatient settings at WAMC and Fort Bragg where recruitment will take place. He

will also make efforts to ensure the safety of any subjects whose emotional state

deteriorates during screening or while in the study. These duties will take 20% effort

(FTE) over 3 years of the project, which will be provided as matching funds ($180,000 x

20% x 3 = $108,000).

Research Coordinator (TBD). This individual (master’s degree level) will be in

charge of recruitment (screening, explaining study and administering consent), in-person

baseline and all follow-up assessments, as well as working with the Data Technician (see

below) to ensure that the data collected are accurately entered into the RedCap database.

This person will also be responsible for advertising the study, contacting potential

participants, and ensuring that recruitment stays on schedule, enrolling a minimum of 1-2

participants per week throughout the 24-month recruitment period. Given the effort

necessary to identify and recruit subjects at this site, and conduct follow-up assessments

at 3, 6, 12, and 24 weeks, this will require 100% effort (FTE) over 3 years, including

training and a buffer time towards the end of the study to ensure that recruitment goals

are met. Thus, we are requesting $75,000 x 100% x 3 = $225,000.

Data Technician (TBD). A data technician (DT) will be needed to (a) enter all

data collected into the RedCap database, and re-enter a second time for double-checking

to ensure that no data entry errors were made during the first entry; (b) help the Research

Coordinator to identify potential subjects through advertising, reviewing medical records

or other lists under the direction of the local/site PI; (c) work with the CTCC to schedule

follow-up assessments and therapist treatment sessions; (d) assist preparation of forms for

IRB submission and renewal; (e) assist the site PI with any paperwork regarding the

study and related secretarial duties; and (f) assist participants and therapists in whatever

needs they may have during the course of the study. These responsibilities will require

50% effort (FTE) over 3 years. Thus, we are requesting $50,000 x 50% x 3 = $75,000.

Miscellaneous costs. The IRB at WAMC charges a one-time fee of $3,000. For

the project coordinator, to set up an office with computer and phone setup is $2,500 and

$1000/year for maintenance of computer/phone/supplies ($5,500). For the half-time data

technician, these costs will be $1,250 and $500/year for maintenance of

computer/phone/supplies ($2,750). We are also requesting miscellaneous supplies

(paper, Xeroxing, etc.) at $500/year. This comes out to a total cost of $3,000 + $5,500 +

$2,750 + $1500 =$12,750 total over 3 years, which we are requesting.

36

Budget Requested:

Direct Costs: 2,125,730 (+ 252,000 salary matching)

Indirect costs (15% Duke): 318,860

Total 2,444,590 for individual donations

37

References 1 Tanielian T, Jaycox LH, eds (2008). Invisible Wounds of War: Psychological and

Cognitive Injuries, their Consequences, and Services to Assist Recovery. Santa Monica,

CA: RAND Corporation. Available at http://www.rand.org/pubs/monographs/

2008/RAND_MG720.pdf, accessed March 24, 2015. 2 Yehuda R (1998). Psychological Trauma. Washington, DC: American Psychiatric Press

3 T.A. Bullman, H.K. Kang (1994). Posttraumatic stress disorder and the risk of

traumatic deaths among Vietnam veterans. Journal of Nervous and Mental Disease 182:

604–610 4 Kang, H. (2009). Analysis of VA Health Care Utilization Among US Global War on

Terrorism (GWOT) Veterans: Unpublished report. Washington DC: VHA Office of

Public Health and Environmental Hazards. 5 Stein, M. B., Kline, N. A., & Matloff, J. L. (2002). Adjunctive olanzapine for SSRI-

resistant combat-related PTSD: a double-blind, placebo-controlled study. American

Journal of Psychiatry 159:1777–1779 6 Rose EM, Westefeld JS, Ansely TN (2001). Spiritual issues in counseling: Clients'

beliefs and preferences. Journal of Counseling Psychology 48:61–71 7 Stanley MA, Bush AL, Camp ME, Jameson JP, Phillips LL, Barber CR, Zeno D,

Lomax JW, Cully JA (2011). Older adults’ preferences for religion/spirituality in

treatment of anxiety and depression. Aging and Mental Health, 15(3):334-343 8 Stein, M. B., Kline, N. A., & Matloff, J. L. (2002). Adjunctive olanzapine for SSRI-

resistant combat-related PTSD: a double-blind, placebo-controlled study. American

Journal of Psychiatry 159:1777–1779 9 Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB (1995). Posttraumatic stress

disorder in the National Coborbidity Survey. Archives of General Psychiatry 52:1048–60 10

Centers for Disease Control. (1988). Health status of Vietnam veterans.

Journal of the American Medical Association 259: 2701 -2724. 11

Kulka, R. A., Schlenger, W. E., Fairbank, J. A., Hough, R. L., Jordan, B. K.,

Marmar, C. R., & Weiss, D. S. (1988). National Vietnam Veterans Readjustment

Study (NVVRS): Description, Current Status, and Initial PTSD Prevalence Estimates.

Final Report. Washington, DC: Veterans Administration. 12

Hines, L. A., Sundin, J., Rona, R. J., Wessely, S., & Fear, N. T. (2014). Posttraumatic

stress disorder post Iraq and Afghanistan: Prevalence among military subgroups.

Canadian Journal of Psychiatry 59(9): 468-479. 13

Moreau C1, Zisook S (2002). Rationale for a posttraumatic stress spectrum disorder.

Psychiatric Clinics of North America 25(4):775-790. 14

McLaughlin KA, Koenen KC, Friedman MJ, Ruscio AM, Karam EG, Shahly V, Stein

DJ, Hill ED, Petukhova M, Alonso J8, Andrade LH, Angermeyer MC, Borges G, de

Girolamo G, de Graaf R, Demyttenaere K, Florescu SE, Mladenova M, Posada-Villa J,

Scott KM, Takeshima T, Kessler RC (2015). Subthreshold posttraumatic stress disorder

in the world health organization world mental health surveys. Biological Psychiatry

77(4):375-384 15

Kasckow J, Yeager DE, Magruder K (2015). Levels of symptom severity and

functioning in four different definitions of subthreshold posttraumatic stress disorder in

primary care veterans. Journal of Nervous and Mental Disease 203(1):43-47

38

16

Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB (1995). Posttraumatic stress

disorder in the National Coborbidity Survey. Archives of General Psychiatry 52:1048–60. 17

Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB (1995). Posttraumatic stress

disorder in the National Coborbidity Survey. Archives of General Psychiatry 52:1048–60 18

Davidson JRT, Hughes D, Blazer D, et al (1991). Posttraumatic stress disorder in the

community: an epidemiological study. Psychological Medicine 21:1–9. 19

Green, B. L., Lindy, J. D., Grace, M. C., & Leonard, A. C. (1992). Chronic

posttraumatic stress disorder and diagnostic comorbidity in a disaster sample. The

Journal of Nervous and Mental Disease 180(12): 760-766. 20

Centers for Disease Control. (1988). Health status of Vietnam veterans.

Journal of the American Medical Association 259: 2701 -2724. 21

Kulka, R. A., Schlenger, W. E., Fairbank, J. A., Hough, R. L., Jordan, B. K.,

Marmar, C. R., & Weiss, D. S. (1988). National Vietnam veterans readjustment

study (NVVRS): Description, Current Status, and Initial PTSD

Prevalence Estimates. Final Report. Washington, DC: Veterans Administration. 22

Kramer, T. L., Booth, B. M., Han, X., & Williams, D. K. (2003). Service utilization

and outcomes in medically ill veterans with posttraumatic stress and depressive disorders.

Journal of Traumatic Stress 16(3): 211-219. 23

Keane, T. M., & Wolfe, J. (1990). Comorbidity In Post‐Traumatic Stress Disorder An

Analysis of Community and Clinical Studies1. Journal of Applied Social Psychology,

20(21), 1776-1788. 24

Sayer N, C.E. Chiros, B. Sigford, S. Scott, M.S. Clothier, T. Pickett, H.L. Lew (2008).

Characteristics and rehabilitation outcomes among patients with blast and other injuries

sustained during the Global War on Terror. Archives of Physical Medicine and

Rehabilitation 89:163–170 25

Kaplan MS, Huguet N, McFarland BH, Newson JT (2007). Suicide among male

veterans: A prospective population-based study. Journal of Epidemiology and

Community Health 61: 619–624 26

Silver JM, R. Kramer, S. Greenwald, M. Weissman (2001). The association between

head injuries and psychiatric disorders: Findings from the New Haven NIMH

epidemiologic catchments area study. Brain Injury 15:935–945 27

Gutierrez PM, L.A. Brenner, J.A. Huggins (2008). A preliminary investigation of

suicidality in psychiatrically hospitalized veterans with traumatic brain injury. Archives

of Suicide Research 12: 336–343 28

Ramchand R, Acosta J, Burns RM, Jaycox LH, Pernin CG. The War Within:

Preventing Suicide in the US Military. Santa Monica, CA: RAND Corporation; 2011. 29

LeardMann, Cynthia A., Teresa M. Powell, Tyler C. Smith, Michael R. Bell, Besa

Smith, Edward J. Boyko, Tomoko I. Hooper, Gary D. Gackstetter, Mark Ghamsary, and

Charles W. Hoge (2013). Risk factors associated with suicide in current and former US

military personnel. JAMA 310 (5): 496-506. 30

N. Tarrier, K. Taylor, P.A. Gooding (2008). Cognitive-behavioral interventions to

reduce suicide behavior: A systematic review and meta-analysis. Behavior Modification

32: 77–108 31

Jakupcak, M., & Varra, E. M. (2011). Treating Iraq and Afghanistan war veterans with

PTSD who are at high risk for suicide. Cognitive and Behavioral Practice 18(1): 85-97.

39

32

Luxton, D. D., Greenburg, D., Ryan, J., Niven, A., Wheeler, G., & Mysliwiec, V.

(2011). Prevalence and impact of short sleep duration in redeployed OIF soldiers. Sleep

34(9): 1189-1195 33

Mustafa, M., Erokwu, N., Ebose, I., & Strohl, K. (2005). Sleep problems and the risk

for sleep disorders in an outpatient veteran population. Sleep and Breathing 9(2): 57-63. 34

Matsuwaka, S., Martin, J., & Alessi, C. (2013). Insomnia in Older Veterans:

Prevalence, Self-Rated Health, and Talking to a Doctor About Sleep Problems. Hawai'i

Journal of Medicine & Public Health 72(9 Suppl 4): 63. 35

McLay RN, Klam WP, Volkert SL (2010). Insomnia is the most commonly reported

symptom and predicts other symptoms of post-traumatic stress disorder in U.S. service

members returning from military deployments. Military Medicine 175:759-62. 36

Lewis V, Creamer M, Failla S (2009). Is poor sleep in veterans a function of

posttraumatic stress disorder? Military Medicine 174:948-951. 37

Maher, M. J., Rego, S. A., & Asnis, G. M. (2006). Sleep disturbances in patients with

post-traumatic stress disorder: epidemiology, impact and approaches to management.

CNS drugs 20:567-590. 38

Hoge, C. W., Terhakopian, A., Castro, C. A., Messer, S. C., & Engel, C. C. (2007).

Association of posttraumatic stress disorder with somatic symptoms, health care visits,

and absenteeism among Iraq war veterans. American Journal of Psychiatry 164(1): 150-

153. 39

Inman, D. J., Silver, S. M., & Doghramji, K. (1990). Sleep disturbance in post-

traumatic stress disorder: a comparison with non-PTSD insomnia. Journal of Traumatic

Stress 3(3):429-437. 40

Ulmer, C. S., Edinger, J. D., & Calhoun, P. S. (2011). A multi-component cognitive-

behavioral intervention for sleep disturbance in veterans with PTSD: a pilot study.

Journal of Clinical Sleep Medicine 7(1): 57-68. 41

Bellamy, R. F. (1992). The medical effects of conventional weapons. World Journal of

Surgery 16(5): 888-892. 42

Warden, D. (2006). Military TBI during the Iraq and Afghanistan wars. Journal of

Head Trauma Rehabilitation 21(5): 398-402. 43

Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL (2004).

Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. New

England Journal of Medicine 351:13–22 44

Hoge, C. W., Terhakopian, A., Castro, C. A., Messer, S. C., & Engel, C. C. (2007).

Association of posttraumatic stress disorder with somatic symptoms, health care visits,

and absenteeism among Iraq war veterans. American Journal of Psychiatry 164(1): 150-

153. 45

Grieger, Thomas A., Stephen J. Cozza, Robert J. Ursano, Charles Hoge, Patricia E.

Martinez, Charles C. Engel, and Harold J. Wain (2006). Posttraumatic stress disorder and

depression in battle-injured soldiers. American Journal of Psychiatry 163(10) :1777-

1783. 46

Thomas JL, Wilk JE, Riviere LA, McGurk D, Castro CA, Hoge CW (2010).

Prevalence of mental health problems and functional impairment among active

component and National Guard soldiers 3 and 12 months following combat in Iraq.

Archives of General Psychiatry 67(6):614-623.

40

47

Frayne SM, Chiu VY, Iqbal S, et al (2011). Medical care needs of returning veterans

with PTSD: their other burden. Journal of General Internal Medicine 26:33–39. 48

Coughlin S (2011). Post-traumatic stress disorder and cardiovascular disease. Open

Cardiovascular Medical Journal 5:164–170. 49

Friedman, M. J. (1981). Post-Vietnam syndrome: Recognition and management.

Psychosomatics 22: 931−943. 50

Fontana, A., & Rosenheck, R. (2004). Trauma, change in strength of religious faith,

and mental health service use among veterans treated for PTSD. Journal of Nervous and

Mental Disease 192(9): 579-584. 51

Litz, B. T., Stein, N., Delaney, E., Lebowitz, L., Nash, W. P., Silva, C., & Maguen, S.

(2009). Moral injury and moral repair in war veterans: A preliminary model and

intervention strategy. Clinical Psychology Review 29(8): 695-706. 52

Drescher, K. D., Foy, D. W., Kelly, C., Leshner, A., Schutz, K., & Litz, B. (2011). An

exploration of the viability and usefulness of the construct of moral injury in war

veterans. Traumatology 17(1): 8-13. 53 Litz, B. T., Stein, N., Delaney, E., Lebowitz, L., Nash, W. P., Silva, C., & Maguen, S.

(2009). Moral injury and moral repair in war veterans: A preliminary model and

intervention strategy. Clinical Psychology Review 29(8): 695-706. 54

Worthington Jr, E. L., & Langberg, D. (2012). Religious considerations and self-

forgiveness in treating complex trauma and moral injury in present and former soldiers.

Journal of Psychology and Theology 40(4): 274-288. 55

Foa EB, Kozak MJ. 1986. Emotional processing of fear: exposure to corrective

information. Psychologica. Bulletin 99:20–35 56

Resick PA, Nishith P, Weaver TL, et al. 2002. A comparison of cognitive-processing

therapy with prolonged exposure and a waiting condition for the treatment of chronic

posttraumatic stress disorder in female rape victims. Journal of Consulting & Clinical

Psychology 70:867–79 57

Difede, J., Olden, M., & Cukor, J. (2014). Evidence-based treatment of post-traumatic

stress disorder. Annual Review of Medicine, 65, 319-332. 58

Watts BV, Schnurr PP, Mayo L, et al (2013). Meta-analysis of the efficacy of

treatments for posttraumatic stress disorder. Journal of Clinical Psychiatry 74(6):e541-

e550 59

Holliday, R., Link-Malcolm, J., Morris, E. E., & Surís, A. (2014). Effects of cognitive

processing therapy on PTSD-related negative cognitions in veterans with military sexual

trauma. Military Medicine 179(10):1077-1082. 60

Mullen, K., Holliday, R., Morris, E., Raja, A., & Surís, A. (2014). Cognitive

processing therapy for male veterans with military sexual trauma-related posttraumatic

stress disorder. Journal of Anxiety Disorders, 28(8), 761-764. 61

Surís, A., Link‐Malcolm, J., Chard, K., Ahn, C., & North, C. (2013). A randomized

clinical trial of cognitive processing therapy for veterans with PTSD related to military

sexual trauma. Journal of Traumatic Stress, 26(1), 28-37. 62

Walter, K. H., Dickstein, B. D., Barnes, S. M., & Chard, K. M. (2014). Comparing

Effectiveness of CPT to CPT‐C Among US Veterans in an Interdisciplinary Residential

PTSD/TBI Treatment Program. Journal of Traumatic Stress, 27(4), 438-445.

41

63

Chard, K. M., Schumm, J. A., Owens, G. P., & Cottingham, S. M. (2010). A

comparison of OEF and OIF veterans and Vietnam veterans receiving cognitive

processing therapy. Journal of Traumatic Stress, 23(1), 25-32 64

Walter, Kristen H., Ruth L. Varkovitzky, Gina P. Owens, Jennifer Lewis, Kathleen M.

Chard, K. H. Walter, R. L. Varkovitzky, G. P. Owens, J. Lewis, and K. M. Chard.

Cognitive Processing Therapy for Veterans With Posttraumatic Stress Disorder: A

Comparison Between Outpatient and Residential Treatment . Journal of Consulting and

Clinical Psychology. Journal of Consulting and Clinical Psychology 82, no. 4 (2014):

551-561. 65

Alvarez J, McLean C, Harris AH, Rosen CS, Ruzek JI, Kimerling R (2011). The

comparative effectiveness of cognitive processing therapy for male veterans treated in a

VHA posttraumatic stress disorder residential rehabilitation program. Journal of

Consulting and Clinical Psychology 79(5):590-9 66

Monson CM, Schnurr PP, Resick PA, et al. 2006. Cognitive processing therapy for

veterans with military related posttraumatic stress disorder. Journal of Consulting and

Clinical Psychology 74:898–907 67

Foa, E. B., Hembree, E. A., & Rothbaum, B. O. (2007). Prolonged Exposure Therapy

for PTSD: Emotional processing of traumatic experiences. New York, NY: Oxford

University Press. 68

Resick, P. A., Monson, C. M., & Chard, K. M. (2008). Cognitive Processing Therapy:

Veteran/Military Version.Washington, DC: Department of Veterans Affairs. Retrieved

from http://www.greenbookee.com/cognitive-processing-therapy-manual-8-08/ (3-24-15) 69

Karlin, B. E., Ruzek, J. I., Chard, K. M., Eftekhari, A., Monson, C. M., Hembree, E.

A., Foa, E. B. (2010). Dissemination of evidence-based psychological treatments for

posttraumatic stress disorder in the Veterans Health Administration. Journal of

Traumatic Stress, 23, 663–673. 70

Eftekhari, A., Ruzek, J. I., Crowley, J. J., Rosen, C. S., Greenbaum, M. A., & Karlin,

B. E. (2013). Effectiveness of national implementation of prolonged exposure therapy in

Veterans Affairs care. JAMA Psychiatry, 70, 949–955. 71

McHugh, R. K., & Barlow, D. H. (2010). The dissemination and implementation of

evidence-based psychological treatments: A review of current efforts. American

Psychologist, 65, 73–84. 72

Mott, J. M., Hundt, N. E., Sansgiry, S., Mignogna, J., & Cully, J. A. (2014). Changes

in psychotherapy use among veterans with depression, anxiety, and PTSD. Psychiatric

Services, 65, 106–112 73

Seal, K. H., Maguen, S., Cohen, B., Gima, K. S., Metzler, T. J Ren L, Bertenthal D,

Marmar CR (2010). VA mental health services utilization in Iraq and Afghanistan

veterans in the first year of receiving new mental health diagnoses. Journal of Traumatic

Stress, 23, 5–16. 74

Shiner, B., D’Avolio, L. W., Nguyen, T. M., Zayed MH, Young-Xu Y, Desai RA,

Schnurr PP, Fiore LD, Watts BV (2012). Measuring use of evidence based psychotherapy

for posttraumatic stress disorder. Administration and Policy in Mental Health and Mental

Health Services Research 40: 311–318. 75

Freud, S. (1927). Future of an Illusion. In Strachey J (editor and translator), Standard

Edition of the Complete Psychological Works of Sigmund Freud. London: Hogarth Press,

1962, p 43

42

76

Larson, D.B., Thielman, S.B., Greenwold, M.A., Lyons, J.S., Post, S.G., Sherrill, K.A.,

Wood, G.G., & Larson, S.S. (1993). Religious content in the DSM-III-R glossary of

technical terms. American Journal of Psychiatry 150, 1884-1885. 77

Watters, W. (1992). Deadly Doctrine: Health, Illness, and Christian God-Talk.

Buffalo, New York: Prometheus Books 78

Jones HE (2007). Religion: The Etiology of Mental Illness. Mental Health Education

Press 79

Curlin FA, Lawrence RE, Odell S, Chin MH, Lantos JD, Koenig HG, Meador KG

(2007). Religion, spirituality, and medicine: Psychiatrists’ and other physicians’ differing

observations, interpretations, and clinical approaches. American Journal of Psychiatry

164, 1825-1831 80

Weaver, AJ (1995). Has there been a failure to prepare and support.-based clergy in

their role as front-line community mental health workers?: A review. The Journal of

Pastoral Care, 49,129-149 81

Currier, J. M., Holland, J. M., Drescher, K., & Foy, D. (2013). Initial Psychometric

Evaluation of the Moral Injury Questionnaire—Military Version. Clinical psychology &

psychotherapy. 82

Witvliet, C. V. O., Phillips, K. A., Feldman, M. E., & Beckham, J. C. (2004).

Posttraumatic mental and physical health correlates of forgiveness and religious coping in

military veterans. Journal of Traumatic Stress, 17, 269–273. 83

Currier, J. M., Drescher, K. D., & Harris, J. I. (2014). Spiritual functioning among

veterans seeking residential treatment for PTSD: A matched control group study.

Spirituality in Clinical Practice 1(1): 3-15. 84

Fontana A, Rosenheck R (2004). Trauma, change in strength of religious faith, and

mental health service use among veterans treated for PTSD. Journal of Nervous &

Mental Disease 192(9):579-584. 85

Fontana A, Rosenheck R (2004). Trauma, change in strength of religious faith, and

mental health service use among veterans treated for PTSD. Journal of Nervous &

Mental Disease 192(9):579-584. 86

Pressman, P., Lyons, J.S., Larson, D.B., & Strain, J.J. (1990). Religious belief,

depression, and ambulation status in elderly women with broken hips. American Journal

of Psychiatry, 147, 758-759. 87

Koenig HG (2007). Religion and remission of depression in medical inpatients with

heart failure/pulmonary disease. Journal of Nervous and Mental Disease 195:389-395 88

Koenig HG, George LK, Peterson BL (1998). Religiosity and remission of depression

in medically ill older patients. American Journal of Psychiatry 155, 536-542. 89

Koenig, H.G., Cohen, H.J., Blazer, D.G., Pieper, C., & Meador, K.G., Shelp, F., Goli,

V., & DiPasquale, R. (1992). Religious coping and depression in elderly hospitalized

medically ill men. American Journal of Psychiatry, 149, 1693-1700. 90

Benda, B. B. (2002). Factors associated with rehospitalization among veterans in a

substance abuse treatment program. Psychiatric Services 53(9):1176-1178 91

Pietrzak, R. H., & Cook, J. M. (2013). Psychological resilience in older US veterans:

results from the National Health and Resilience in Veterans Study. Depression and

Anxiety 30(5): 432-443.

43

92

Currier, J. M., Drescher, K. D., & Harris, J. I. (2014). Spiritual functioning among

veterans seeking residential treatment for PTSD: A matched control group study.

Spirituality in Clinical Practice 1(1): 3-15. 93

Ogden, H., Harris, J. I., Erbes, C., Engdahl, B., Olson, R.,Winskowski, A. M., &

McMahill J. (2011). Religious functioning and trauma outcomes among combat veterans.

Counselling and Spirituality, 30, 71–89. 94

Tsai J, El-Gabalawy, Sledge WH, Southwick SM, Pietrzak RH (2015). Post-traumatic

growth among veterans in the USA: Results from the National Health and Resilience in

Veterans Study. Psychological Medicine 45:165-179 95

Currier JM, Holland JM, Drescher KD (2015). Spirituality factors in the prediction of

outcomes of PTSD treatment for U.S. military veterans. Journal of Traumatic Stress

28(1):57-64 96

Witvliet, C. V. O., Phillips, K. A., Feldman, M. E., & Beckham, J. C. (2004).

Posttraumatic mental and physical health correlates of forgiveness and religious coping in

military veterans. Journal of Traumatic Stress, 17, 269–273. 97

Currier, J. M., Drescher, K. D., & Harris, J. I. (2014). Spiritual functioning among

veterans seeking residential treatment for PTSD: A matched control group study.

Spirituality in Clinical Practice 1(1): 3-15. 98

Ogden, H., Harris, J. I., Erbes, C., Engdahl, B., Olson, R.,Winskowski, A. M., &

McMahill J. (2011). Religious functioning and trauma outcomes among combat veterans.

Counselling and Spirituality, 30, 71–89. 99

Bormann, J. E., Thorp, S., Wetherell, J. L., & Golshan, S. (2008). A spiritually based

group intervention for combat veterans with posttraumatic stress disorder: feasibility

study. Journal of Holistic Nursing, 26(2), 109-116 100

Kearney, D. J., McDermott, K., Malte, C., Martinez, M., & Simpson, T. L. (2012).

Association of participation in a mindfulness program with measures of PTSD,

depression and quality of life in a veteran sample. Journal of Clinical Psychology 68(1):

101-116. 101

Vujanovic, A. A., Niles, B., Pietrefesa, A., Schmertz, S. K., & Potter, C. M. (2013).

Mindfulness in the treatment of posttraumatic stress disorder among military veterans.

Spirituality in Clinical Practice 1:15-25 102

Rutledge, T., Nidich, S., Schneider, R. H., Mills, P. J., Salerno, J., Heppner, P., ... &

Rainforth, M. (2014). Design and rationale of a comparative effectiveness trial evaluating

transcendental meditation against established therapies for PTSD. Contemporary clinical

trials, 39(1), 50-56. 103

Propst, L.R. (1980). The comparative efficacy of religious and nonreligious imagery

for the treatment of mild depression in religious individuals. Cognitive Therapy and

Research, 4, 167-178 104

Propst, L.R., Ostrom, R., Watkins, P., Dean, T., & Mashburn, D. (1992). Comparative

efficacy of religious and nonreligious cognitive-behavior therapy for the treatment of

clinical depression in religious individuals. Journal of Consulting and Clinical

Psychology, 60, 94-103. 105

Azhar, M.Z., Varma, S.L., & Dharap, A.S. (1994). Religious psychotherapy in

anxiety disorder patients. Acta Psychiatrica Scandinavica 90: 1-3. 106

Azhar, M. Z., & Varma, SL (1995). Religious psychotherapy in depressive patients.

Psychotherapy & Psychosomatics 63:165-173.

44

107

Azhar, M. Z., & Varma, SL (1995). Religious psychotherapy as management of

bereavement. Acta Psychiatrica Scandinavica 91:233-235 108

Razali, S. M., Hasanah, CI, Aminah, K., Subramaniam, M. (1998). Religious--

sociocultural psychotherapy in patients with anxiety and depression. Australian & New

Zealand Journal of Psychiatry 32: 867-872. 109

Xiao, S., Young, D., Zhang, H. (1998). Taoistic cognitive psychotherapy for neurotic

patients: a preliminary clinical trial. Psychiatry & Clinical Neurosciences 52

(supplement): S238-241. 110

Koenig HG, Pearce MJ, Nelson B, Shaw SF, Robins CJ, Daher N, Cohen HJ, Berk

LS, Belinger D, Pargament KI, Rosmarin DH, Vasegh S, Kristeller J, Juthani N, Nies D,

King MB (2015). Religious vs. conventional cognitive-behavioral therapy for major

depression in persons with chronic medical illness. Journal of Nervous and Mental

Disease 203(4): 243-251 111

Pew Forum (2007). U.S. religious landscape survey. See website:

http://religions.pewforum.org/ 112

The Gallup Poll (2009). State of the States: Importance of Religion. See website:

http://www.gallup.com/poll/114022/state-states-importance-religion.aspx 113

Koenig HG (1998). Religious beliefs and practices of hospitalized medically ill older

adults. International Journal of Geriatric Psychiatry, 13, 213-224 114

Koenig HG (1994): Aging and God: Spiritual Paths to Mental Health in Midlife and

Later Years. NY: Haworth Press 115

Koenig HG, Pargament KI, Nielsen J (1998). Religious coping and health outcomes in

medically ill hospitalized older adults. Journal of Nervous and Mental Disorder 186: 513-

521 116

Rose EM, Westefeld JS, Ansely TN (2001). Spiritual issues in counseling: Clients'

beliefs and preferences. Journal of Counseling Psychology 48:61–71 117

Stanley MA, Bush AL, Camp ME, Jameson JP, Phillips LL, Barber CR, Zeno D,

Lomax JW, Cully JA (2011). Older adults’ preferences for religion/spirituality in

treatment of anxiety and depression. Aging and Mental Health, 15(3):334-343 118

Barlas FM, Higgins WB, Pflieger JC, Diecker K (2013). 2011 Health Related

Behaviors Survey of Active Duty Military Personnel: Executive Summary (Department of

Defense). Contract No. GS-23F-8182H. 119

Maxfield B (2014). FY13 Army religious affiliations. Source: Chief, Office of Army

Demographics (DMDC West) 120

Witvliet, C. V. O., Phillips, K. A., Feldman, M. E., & Beckham, J. C. (2004).

Posttraumatic mental and physical health correlates of forgiveness and religious coping in

military veterans. Journal of Traumatic Stress, 17, 269–273. 121

Johnson, G. D., Matre, M., & Armbrecht, G. (1991). Race and religiosity: An

empirical evaluation of a causal model. Review of Religious Research, 252-266. 122 Koenig HG, King DE, Carson VB (2012). Handbook of Religion and Health, 2

nd ed.

NY, NY: Oxford University Press 123

Litz, B. T., Stein, N., Delaney, E., Lebowitz, L., Nash, W. P., Silva, C., & Maguen, S.

(2009). Moral injury and moral repair in war veterans: A preliminary model and

intervention strategy. Clinical Psychology Review 29(8): 695-706. 124

Kopacz, M. S., & Connery, A. L. (2015). The veteran spiritual struggle. Spirituality in

Clinical Practice 2(1): 61-67

45

125

Rose, S., Aiken, A., & McColl, M. A. (2014). A Scoping Review of Psychological

Interventions for PTSD in Military Personnel and Veterans. Military Behavioral Health,

2(3), 264-282. 126

Currier JM, Holland JM, Drescher KD (2015). Spirituality factors in the prediction of

outcomes of PTSD treatment for U.S. military veterans. Journal of Traumatic Stress

28(1):57-64 127

Currier, J. M., Drescher, K. D., Holland, J. M., Lisman, R., & Foy, D. W. (2015).

Spirituality, forgiveness, and quality of life: Testing a mediational model with military

veterans with PTSD. International Journal for the Psychology of Religion, in press 128

The Management of Post-Traumatic Stress Working Group (October 2010).

DOD-VA Clinical Practice Guideline: Management of Post-Traumatic Stress.

Washington DC: Department of Veterans Affairs and Department of Defense, p 149 129

Hoge, C. W., Riviere, L. A., Wilk, J. E., Herrell, R. K., & Weathers, F. W. (2014). The

prevalence of post-traumatic stress disorder (PTSD) in US combat soldiers: a head-to-

head comparison of DSM-5 versus DSM-IV-TR symptom criteria with the PTSD

checklist. Lancet Psychiatry 1(4): 269-277. 130

Hoge, C. W., Castro, C. A., Messer, S. C., McGurk, D., Cotting, D. I., & Koffman, R.

L. (2004). Combat duty in Iraq and Afghanistan, mental health problems, and barriers to

care. New England Journal of Medicine 351(1): 13-22. 131

Seal, K. H., Bertenthal, D., Miner, C. R., Sen, S., & Marmar, C. (2007). Bringing the

war back home: Mental health disorders among 103 788 US veterans returning from Iraq

and Afghanistan seen at Department of Veterans Affairs Facilities. Archives of Internal

Medicine 167(5):476-482. 132

Kasckow J, Yeager DE, Magruder K (2015). Levels of symptom severity and

functioning in four different definitions of subthreshold posttraumatic stress disorder in

primary care veterans. Journal of Nervous and Mental Disease 203(1):43-47 133

The Management of Post-Traumatic Stress Working Group (October 2010).

DOD-VA Clinical Practice Guideline: Management of Post-Traumatic Stress.

Washington DC: Department of Veterans Affairs and Department of Defense, pp 115,

117, 120, 122, 194 134

Gallagher, M. W., Thompson-Hollands, J., Bourgeois, M. L., & Bentley, K. H. (2015).

Cognitive Behavioral Treatments for Adult Posttraumatic Stress Disorder: Current Status

and Future Directions. Journal of Contemporary Psychotherapy, E-pub ahead of print

(DOI: 10.1007/s10879-015-9303-6). 135

Resick, P. A., Nishith, P., Weaver, T. L., Astin, M. C., & Feuer, C. A. (2006).

Cognitive Processing Therapy: Veteran/Military Version. Clinical Psychology 74:898-

907. 136

Pearce MJ, Koenig HG, Robins CJ, Nelson B, Shaw SF, Cohen HJ, King MB (2015).

Religiously-integrated cognitive behavioral therapy: A new method of treatment for

major depression in patients with chronic medical illness. Psychotherapy 52(1):56-66 137

Koenig HG, Pearce MJ, Nelson B, Shaw SF, Robins CJ, Daher N, Cohen HJ, Berk LS,

Belinger D, Pargament KI, Rosmarin DH, Vasegh S, Kristeller J, Juthani N, Nies D, King

MB (2015). Religious vs. conventional cognitive-behavioral therapy for major

depression in persons with chronic medical illness. Journal of Nervous and Mental

Disease 203(4): 243-251

46

138

Center for Spirituality, Theology and Health (2014). Manuals. Durham, NC: Duke

University Medical Center. See website:

http://www.spiritualityandhealth.duke.edu/index.php/religious-cbt-study/therapy-manuals 139

Koenig HG (2012). Religious vs. conventional psychotherapy for major depression in

patients with chronic medical illness: Rationale, methods, and preliminary results.

Depression Research andTreatment 2012 article ID 460419, doi:10.1155/2012/460419 140

Koenig HG, Berk LS, Daher N, Pearce MJ, Belinger D, Robins CJ, Nelson B, Shaw

SF, Cohen HJ, King MB (2014). Religious involvement, depressive symptoms, and

positive emotions in the setting of chronic medical illness and major depression. Journal

of Psychosomatic Research 77:135-43 141

Bellinger DL, Berk LS, Koenig HG, Daher N, Pearce MJ, Robins CJ, Nelson B, Shaw

SF, Cohen HJ, King MB (2014). Religious involvement, inflammatory markers and

stress hormones in major depression and chronic medical illness. Open Journal of

Psychiatry 4(4):335-352 142

Koenig HG, Pearce MJ, Nelson B, Shaw SF, Robins CJ, Daher N, Cohen HJ, Berk

LS, Belinger D, Pargament KI, Rosmarin DH, Vasegh S, Kristeller J, Juthani N, Nies D,

King MB (2015). Religious vs. conventional cognitive-behavioral therapy for major

depression in persons with chronic medical illness. Journal of Nervous and Mental

Disease 203(4): 243-251 143

Koenig HG, Pearce MJ, Nelson B, Shaw SF, Robins CJ, Daher N, Cohen HJ, King

MB (2015). Effects of religious vs. conventional cognitive behavioral therapy on

therapeutic alliance: A randomized clinical trial. Psychotherapy Research, in press 144

Koenig HG, Gutierrez B, Cervilla J, Pearce MJ, Daher N, Nelson B, Shaw SF, Cohen

HJ, King MB (2015). Genetic polymorphisms, religious involvement, and response to

religious vs. conventional psychotherapy in a randomized clinical trial. Austin Journal of

Psychiatry & Behavioral Sciences, in submission 145

Berk LS, Bellinger DL, Koenig HG, Daher N, Pearce MJ, Robins CJ, Nelson B, Shaw

SF, Cohen HJ, King MB (2015). Effects of religious vs. conventional cognitive-

behavioral therapy on inflammatory markers and stress hormones in major depression

and chronic medical illness: A randomized clinical trial. Open Journal of Psychiatry, in

submission 146

Pearce MJ, Koenig HG, Robins CJ, Daher N, Shaw SF, Nelson B, Berk LS, Belinger

D, Cohen HJ, King MB (2015). Effects of religious vs. conventional cognitive-

behavioral therapy on gratefulness in major depression chronic medical illness: A

randomized clinical trial. Mental Health, Religion and Culture, in submission 147

Daher N, Koenig HG, Pearce MJ, Nelson B, Shaw SF, Berk LS, Belinger D, Robins

CJ, Cohen HJ, King MB (2015). Effects of religious vs. conventional cognitive-

behavioral therapy on purpose in life in the setting of major depression and chronic

illness. Journal of Positive Psychology, in submission 148

Koenig HG, Pearce MJ, Nelson B, Daher N (2015). Effects of religious vs.

conventional cognitive-behavioral therapy on optimism in persons with major depression

and chronic medical illness: A randomized clinical trial. Depression and Anxiety, in

submission 149

Pearce MJ, Koenig HG, Robins CJ, Daher N, Shaw SF, Nelson B, Berk LS, Belinger

D, Cohen HJ, King MB (2015). Effects of religious vs. conventional cognitive-

47

behavioral therapy on generosity in major depression chronic medical illness: A

randomized clinical trial. Spirituality in Clinical Practice, in submission 150

Pearce MJ, Koenig (2015). Effects of religious vs. conventional cognitive-behavioral

therapy on spiritual struggles in major depression and chronic medical illness: A

randomized clinical trial. International Journal of the Psychology of Religion, in

submission 151 Koenig HG, Pearce MJ, Nelson B, Shaw SF, Robins CJ, Daher N, Cohen HJ, Berk

LS, Belinger D, Pargament KI, Rosmarin DH, Vasegh S, Kristeller J, Juthani N, Nies D,

King MB (2015). Religious vs. conventional cognitive-behavioral therapy for major

depression in persons with chronic medical illness. Journal of Nervous and Mental

Disease 203(4): 243-251 152

Vallis TM, Shaw BG, Dobson KS (1986). The Cognitive Therapy Scale:

psychometric properties. Journal of Consulting and Clinical Psychology 54, 381-385 153

Young J, Beck A (1980). Cognitive Therapy Scale: Rating Manual. Unpublished

manuscript. Philadelphia, PA: Center for Cognitive Therapy 154

Waltz J, Addis ME, Koerner K, Jacobson NS (1993). Testing the integrity of a

psychotherapy protocol: assessment of adherence and competence. Journal of

Consulting and Clinical Psychology 61, 620-630 155

Koenig HG, Pearce MJ, Nelson B, Shaw SF, Robins CJ, Daher N, Cohen HJ, Berk

LS, Belinger D, Pargament KI, Rosmarin DH, Vasegh S, Kristeller J, Juthani N, Nies D,

King MB (2015). Religious vs. conventional cognitive-behavioral therapy for major

depression in persons with chronic medical illness. Journal of Nervous and Mental

Disease 203(4): 243-251 156

Anderson N, Heywood-Everett S, Siddiqi N, Wright J, Meredith J, McMillan D

(2015). Faith-adapted psychological therapies for depression and anxiety: Systematic

review and meta-analysis. Journal of Affective Disorders 176:183-196 157

SCID-5-CT: Structured Clinical Interview for DSM-5 Disorders Clinical Trials

Version. Arlington, VA: American Psychiatric Publishing (see website:

http://www.appi.org/pages/scid-5.aspx) 158

American Psychiatric Association. Diagnostic and Statistical Manual of Mental

Disorders, Fourth Edition, DSM-4. Washington DC: American Psychiatric Association,

1994 159

American Psychiatric Association. Diagnostic and Statistical Manual of Mental

Disorders, Fifth Edition, DSM-5. Washington DC: American Psychiatric Association,

2013. 160

Thorp SR, Sones HM, Cook JM: Posttraumatic stress disorder among older adults, in

Cognitive Behavior Therapy With Older Adults: Innovations Across Care Settings.

Edited by Sorocco KH, Lauderdale S. New York, Springer, 2011, pp 189–217 161

McLaughlin KA, Koenen KC, Friedman MJ, Ruscio AM, Karam EG, Shahly V, Stein

DJ, Hill ED, Petukhova M, Alonso J8, Andrade LH, Angermeyer MC, Borges G, de

Girolamo G, de Graaf R, Demyttenaere K, Florescu SE, Mladenova M, Posada-Villa J,

Scott KM, Takeshima T, Kessler RC (2015). Subthreshold posttraumatic stress disorder

in the world health organization world mental health surveys. Biological Psychiatry

77(4):375-384 162

Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA: Psychometric properties

of the PTSD Checklist (PCL). Behav Res Ther 1996; 34:669–673

48

163

Dobie DJ, Kivlahan DR, Maynard C, Bush KR, McFall M, Epler AJ, Bradley KA:

Screening for post-traumatic stress disorder in female Veteran’s Affairs patients:

validation of the PTSD Checklist. Gen Hosp Psychiatry 2002; 24:367–374 164

Forbes D, Creamer M, Biddle D: The validity of the PTSD Checklist as a measure of

symptomatic change in combat-related PTSD. Behav Res Ther 2001; 39:977–986 165

Karstoft, K. I., Andersen, S. B., Bertelsen, M., & Madsen, T. (2014). Diagnostic

accuracy of the Posttraumatic Stress Disorder Checklist–Civilian Version in a

representative military sample. Psychological Assessment, 26(1), 321. 166

Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL: Combat duty

in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med

2004; 351:13–22 167

Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA: Psychometric properties

of the PTSD Checklist (PCL). Behav Res Ther 1996; 34:669–673 168

Karstoft, K. I., Andersen, S. B., Bertelsen, M., & Madsen, T. (2014). Diagnostic

accuracy of the Posttraumatic Stress Disorder Checklist–Civilian Version in a

representative military sample. Psychological Assessment, 26(1), 321. 169

Biehn TL, Elhai JD, Seligman LD, Tamburrino M, Armour C, Forbes D. Underlying

dimensions of DSM-5 posttraumatic stress disorder and major depressive disorder

symptoms Psychol Inj and Law 2013; 6: 290–98. 170

Hoge, C. W., Riviere, L. A., Wilk, J. E., Herrell, R. K., & Weathers, F. W. (2014). The

prevalence of post-traumatic stress disorder (PTSD) in US combat soldiers: a head-to-

head comparison of DSM-5 versus DSM-IV-TR symptom criteria with the PTSD

checklist. The Lancet Psychiatry, 1(4), 269-277. 171

Hoge, C. W., Riviere, L. A., Wilk, J. E., Herrell, R. K., & Weathers, F. W. (2014). The

prevalence of post-traumatic stress disorder (PTSD) in US combat soldiers: a head-to-

head comparison of DSM-5 versus DSM-IV-TR symptom criteria with the PTSD

checklist. The Lancet Psychiatry, 1(4), 269-277. 172

Hoge, C. W., Riviere, L. A., Wilk, J. E., Herrell, R. K., & Weathers, F. W. (2014). The

prevalence of post-traumatic stress disorder (PTSD) in US combat soldiers: a head-to-

head comparison of DSM-5 versus DSM-IV-TR symptom criteria with the PTSD

checklist. The Lancet Psychiatry, 1(4), 269-277. 173

Hoge, C. W., Riviere, L. A., Wilk, J. E., Herrell, R. K., & Weathers, F. W. (2014). The

prevalence of post-traumatic stress disorder (PTSD) in US combat soldiers: a head-to-

head comparison of DSM-5 versus DSM-IV-TR symptom criteria with the PTSD

checklist. The Lancet Psychiatry, 1(4), 269-277. 174

Keane, T. M., Fairbank, J. A., Caddell, J. M., Zimering, R. T., Taylor, K. L., & Mora,

C. A. (1989). Clinical evaluation of a measure to assess combat exposure. Psychological

Assessment 1:53–55. 175

Ware JE, Sherbourne CD (1992) The MOS 36-item Short-Form health survey (SF-

36): I. Conceptual framework and item selection. Medical Care 30, 473-83. 176

Koenig HG (1996). An abbreviated Mini-Mental State Exam for medically ill elders.

Journal of the American Geriatrics Society 44:215-216 177

Charlson ME, Pompei P, Ales KL, et al (1987). A new method of classifying

prognostic comorbidity in longitudinal studies: Development and validation. Journal of

Chronic Disease 40:373-383

49

178

Zigmond AS, Snaith RP (1983). The hospital anxiety and depression scale. Acta

Psychiatrica Scandinavica 67(6):361-370. 179

Gough K, Hudson P (2009). Psychometric properties of the Hospital Anxiety and

Depression Scale in family caregivers of palliative care patients. Journal of Pain &

Symptom Management. (5):797-806 180

WHO ASSIST Working Group (2002). The Alcohol, Smoking and Substance

Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction

97:1183-1194 181

Humeniuk R, Ali R, Babor TF, Farrell M, Formigoni ML, Jittiwutikam J, de Lacerda

RB, Ling W, Marsden J, Monteiro M, Nhiwatiwa S, Pal H, Poznyak V, Simon S (2008).

Validation of the Alcohol, Smoking and Substance Involvement Screening Test

(ASSIST). Addiction 103(6):1039-47. 182

McNeely J, Strauss SM, Wright S, et al. Test-retest reliability of a self-administered

Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in primary care

patients. Journal of Substance Abuse & Treatment 2014;47(1):93-101. 183

Buysse, D. J., Reynolds, C. F., Monk, T. H., Berman, S. R., & Kupfer, D. J. (1989).

The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and

research. Psychiatry Research, 28(2), 193-213. 184

Cohen, T. R., Wolf, S. T., Panter, A. T., & Insko, C. A. (2011). Introducing the GASP

scale: A new measure of guilt and shame proneness. Journal of Personality and Social

Psychology, 100(5), 947-966. 185

Drescher, K.D., Foy, D.W., Kelly, C., Leshner, A., Schutz, K., & Litz, B. (2011). An

exploration of the viability and usefulness of the construct of moral injury in war

veterans. Traumatology 17: 8–13. 186

Farnsworth, J. K., Drescher, K. D., Nieuwsma, J. A., Walser, R. B., & Currier, J. M.

(2014). The role of moral emotions in military trauma: Implications for the study and

treatment of moral injury. Review of General Psychology 18(4): 249-262. 187

Currier, J. M., Holland, J. M., Drescher, K., & Foy, D. (2015). Initial psychometric

evaluation of the Moral Injury Questionnaire—Military Version. Clinical Psychology &

Psychotherapy 22(1):54-63. 188

Currier, J. M., Holland, J. M., Drescher, K., & Foy, D. (2015). Initial psychometric

evaluation of the Moral Injury Questionnaire—Military Version. Clinical Psychology &

Psychotherapy 22(1):54-63. 189

Pargament, K.I., Smith, B.W., Koenig, H.G., & Perez, L (1998). Patterns of positive

and negative religious coping with major life stressors. Journal for the Scientific Study of

Religion 37:710-724. 190

Witvliet, C. V. O., Phillips, K. A., Feldman, M. E., & Beckham, J. C. (2004).

Posttraumatic mental and physical health correlates of forgiveness and religious coping in

military veterans. Journal of Traumatic Stress, 17, 269–273. 191

Currier, J. M., Drescher, K. D., & Harris, J. I. (2014). Spiritual functioning among

veterans seeking residential treatment for PTSD: A matched control group study.

Spirituality in Clinical Practice 1(1): 3-15. 192

Ogden, H., Harris, J. I., Erbes, C., Engdahl, B., Olson, R.,Winskowski, A. M., &

McMahill J. (2011). Religious functioning and trauma outcomes among combat veterans.

Counselling and Spirituality, 30, 71–89.

50

193

Duke Depression Evaluation Schedule (1994). Center for the Study of Depression in

Later Life. Durham, NC: Department of Psychiatry, Duke University Medical Center 194

Koenig HG, Meador KG, Parkerson G (1997). Religion index for psychiatric research.

American Journal of Psychiatry 154 (6): 885-886 195

Koenig HG, Meador KG, Parkerson G (1997). Religion index for psychiatric research.

American Journal of Psychiatry 154 (6): 885-886 196

Underwood LG, & Teresi JA (2002). The daily spiritual experiences scale:

development, theoretical description, reliability, exploratory factor analysis, and

preliminary construct validity using health-related data. Annals of Behavioral Medicine

24:22-33 197

Hoge DR (1972). A validated intrinsic religious motivation scale. Journal for the

Scientific Study of Religion 11:369-376 198

Koenig HG, Nelson B, Shaw SF, Al Zaben F, Wang Z, Saxena S (2015). Belief into

Action scale: A brief but comprehensive measure of religious commitment. Open

Journal of Psychiatry 5 (1): 66-77. 199

Krause, N. (2009e). Religious involvement, gratitude, and change in depressive

symptoms over time. International Journal for the Psychology of Religion 19, 155-172 200

Sheldon KM (2006). How to increase and sustain positive emotion: The effects of

expressing gratitude and visualizing vest possible selves. Journal of Positive Psychology

1:73–82. 201

Morris SJ, Kanfer FH (1983). Altruism and depression. Personality and Social

Psychology Bulletin 9:567-577 202

Fujiwara, T. (2007). The role of altruistic behavior in generalized anxiety disorder

and maujor depression among adults in the U.S. Journal of Affective Disorders 101:219-

225 203

Koenig HG, King DE, Carson VB (2011). Handbook of Religion and Health, 2nd

ed.

New York, NY: Oxford University Press, see chapters 6, 7, and 15. 204

Snyder, C. R., Sympson, S. C., Ybasco, F. C., Borders, T. F., Babyak, M. A., &

Higgins, R. L. (1996). Development and validation of the State Hope Scale. Journal of

Personality and Social Psychology 70(2):321-335. 205

Martin-Krumm, C., Delas, Y., Lafrenière, M. A., Fenouillet, F., & Lopez, S. J. (2014).

The structure of the State Hope Scale. Journal of Positive Psychology 10(3): 272-281 206

Gallagher, M. W., & Resick, P. A. (2012). Mechanisms of change in cognitive

processing therapy and prolonged exposure therapy for PTSD: Preliminary evidence for

the differential effects of hopelessness and habituation. Cognitive Therapy and Research

36(6): 750-755. 207

Ryff CD (1989). Beyond Ponce de Leon and life satisfaction: New directions in quest

of successful aging. International Journal of Behavioral Development 12: 35-55 208

Seeman, M. (1991). Alienation and anomie. In Robinson JP, Shaver PR, Wrightsman

LS (eds.), Measures of Personality and Social Psychological Attitudes, volume I. San

Diego: Academic Press, pp. 291–371 209 Ryff CD, & Keyes CLM (1995). The structure of psychological well-being revisited.

Journal of Personal and Social Psychology, 69, 719-727 210

Ryff CD (1989). Beyond Ponce de Leon and life satisfaction: New directions in quest

of successful aging. International Journal of Behavioral Development 12: 35-55

51

211 Ryff CD, & Keyes CLM (1995). The structure of psychological well-being revisited.

Journal of Personal and Social Psychology, 69, 719-727 212 Ryff, C. D., Lee, Y. H., Essex, M. J., & Schmutte, P. S. (1994). My children and me:

midlife evaluations of grown children and of self. Psychology and Aging, 9(2), 195-205 213

Zika S, & Chamberlain K (1992). On the relation between meaning in life and

psychological well-being. British Journal of Psychology 83: 133–145. 214 Seeman, M. (1991). Alienation and anomie. In Robinson JP, Shaver PR, Wrightsman

LS (eds.), Measures of Personality and Social Psychological Attitudes, volume I. San

Diego: Academic Press, pp. 291–371 215

Chamberlain K, Zika S (1988). Religiosity, life meaning, and wellbeing: Some

relationships in a sample of women. Journal for the Scientific Study of Religion 27: 411-

420 216

Seeman, M. (1991). Alienation and anomie. In Robinson JP, Shaver PR, Wrightsman

LS (eds.), Measures of Personality and Social Psychological Attitudes, volume I. San

Diego: Academic Press, pp. 291–371 217

Scheier MF, Carver CS (1985). Optimism, coping, and health: Assessment and

implications for generalized outcome expectancies. Health Psychology 4:219-247 218

Scheier MF, Carver CS, Bridges MW (1994). Distinguishing optimism from

neuroticism (and trait anxiety, self-mastery, and self-esteem): A re-evaluation of the Life

Orientation Test. Journal of Personality and Social Psychology, 67, 1063-1078. 219

Andersson G (1996). The benefits of optimism: A meta-analytic review of the Life

Orientation Test. Personality & Individual Differences 21:719-725 220

Scheier MF, Matthews KA, Owens JF, Schulz R, Bridges MW, Magovern GJ, Carver

CS (1999). Optimism and rehospitalization after coronary artery bypass grant surgery.

Archives of Internal Medicine 149, 829-835 221

Rosenberg, M. (1965). Society and the Adolescent Self-Image. Princeton, NJ:

Princeton University Press. 222

Sinclair SJ, Blais MA, Gansler DA, et al (2010). Psychometric properties of the

Rosenberg self-esteem scale: overall and across demographic groups living within the

United States. Evaluation & Health Professions 33:56–80 223

Cann A, Calhoun LG, Tedeschi RG, Taku K, Vishnevsky T, Triplett KN, Danhauer

SC (2010). A short form of the Posttraumatic Growth Inventory. Anxiety, Stress &

Coping 23(2):127-137. 224

Landerman R, George LK, Campbell RT, Blazer DG (1989). Alternative models of

the stress buffering hypothesis. American Journal of Community Psychology 17:625-642 225

Koenig HG, Westlund RE, George LK, Hughes DC, Blazer DG, Hybels C (1993):

Abbreviating the Duke Social Support Index for use in chronically ill elderly individuals.

Psychosomatics 34:62-69