Duelo Prolongado y CBT

7/26/2019 Duelo Prolongado y CBT

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Research report

Efcacy of an outpatient treatment for prolonged griefdisorder: A randomized controlled clinical trial

Rita Rosner a,b,n, Gabriele Pfoh a, Michaela Kotouov a,1, Maria Hagl a,1

a Department of Psychology, Ludwig-Maximilian-University of Munich, Germanyb Catholic University Eichsttt-Ingolstadt, Ostenstr. 25, D-85071 Eichsttt, Germany

a r t i c l e i n f o

Article history:

Received 26 March 2014Received in revised form

20 May 2014

Accepted 22 May 2014Available online 2 June 2014

Keywords:

Bereavement

Prolonged grief disorder

Complicated grief

Persistent complex bereavement-related

disorder

Randomized controlled trial

Psychotherapy

a b s t r a c t

Background: Abnormal forms of grief, currently referred to as complicated grief or prolonged grief

disorder, have been discussed extensively in recent years. While the diagnostic criteria are still debated,there is no doubt that prolonged grief is disabling and may require treatment. To date, few interventions

have demonstrated efcacy.

Methods: We investigated whether outpatients suffering from prolonged grief disorder (PGD) benet

from a newly developed integrative cognitive behavioural therapy for prolonged grief (PG-CBT). A total of

51 patients were randomized into two groups, stratied by the type of death and their relationship to the

deceased; 24 patients composed the treatment group and 27 patients composed the wait list control

group (WG). Treatment consisted of 2025 sessions. Main outcome was change in grief severity;

secondary outcomes were reductions in general psychological distress and in comorbidity.

Results: Patients on average had 2.5 comorbid diagnoses in addition to PGD. Between group effect sizes

were large for the improvement of grief symptoms in treatment completers (Cohen'sd1.61) and in the

intent-to-treat analysis (d1.32). Comorbid depressive symptoms also improved in PG-CBT compared to

WG. The completion rate was 79% in PG-CBT and 89% in WG.

Limitations: The major limitations of this study were a small sample size and that PG-CBT took longer

than the waiting time.

Conclusions: PG-CBT was found to be effective with an acceptable dropout rate. Given the number ofbereaved people who suffer from PGD, the results are of high clinical relevance.

& 2014 Elsevier B.V. All rights reserved.

1. Introduction

Prolonged grief disorder is being proposed as part of the stress

related disorders category in the ICD-11; in the DSM-5, persistent

complex bereavement disorder is classied as a condition for

further study (American Psychiatric Association, 2013). Despite

this discrepancy, many papers on severely impairing forms of

abnormal grief have been published in the last few decades. The

term complicated grief was coined by Horowitz and his collea-

gues (Horowitz et al., 1997; Prigerson et al., 1995), while trau-matic grief was used by Prigerson and her colleagues (Jacobs,

1999; Prigerson et al., 1997; Shear et al., 2001). As the concepts

evolved, the criteria and denitions for grief varied (for an over-

view and a comparison of the terminology, seeShear et al. (2011)).

However, core symptoms overlap between denitions: for exam-

ple, intense yearning and preoccupation with the loss, reactive

distress symptoms, such as avoidance of memories of the deceased

person and emotional numbing, as well as social/identity disrup-

tion, such as feeling detached or having difculties trusting others.

In this manuscript, we are referring to the respective grief

condition as prolonged grief disorder (PGD). Estimates regarding

the prevalence of PGD vary between studies. While a study from

the USA has reported that approximately 10% of the bereaved

show symptoms that cause impairment in everyday life (Bonanno

et al., 2008; Ott, 2003), European studies have reported prevalence

values of 4.2% in a sample of older Swiss ( Maercker et al., 2008)and 4% in a German sample (Kersting et al., 2011). In the Nether-

lands (Newson et al., 2011), a prevalence of 4.8% was found in a

sample of 5741 adults aged 55 years and older. For those

participants who had experienced a loss, the prevalence of PGD

was 25.4%.

PGD has been found to be associated with deteriorated health

(Stroebe et al., 2007), increased depression, and suicidality (Boelen

and Prigerson, 2007; Latham and Prigerson, 2004). Having a

diagnosis of PGD six months after a loss correlated with an

increased risk for heart disease, high blood pressure, cancer, and

altered eating habits (Prigerson et al., 2008). Furthermore, PGD has

Contents lists available at ScienceDirect

journal homepage: www.elsevier.com/locate/jad

Journal of Affective Disorders

http://dx.doi.org/10.1016/j.jad.2014.05.035

0165-0327/& 2014 Elsevier B.V. All rights reserved.

n Corresponding author at: Catholic University Eichstaett-Ingolstadt, Ostenstr. 25,

D-85071 Eichsttt, Germany. Tel.: 49 8421 93 1581; fax: 49 8421 93 2033.

E-mail address:[email protected](R. Rosner).1 MK and MH are no longer afliated with the Ludwig-Maximilian-University

Journal of Affective Disorders 167 (2014) 5663
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been effectively differentiated from depression and posttraumatic

stress disorder (PTSD) (Boelen and van den Bout, 2005; Boelen et

al., 2008). However, PGD is often comorbid with these disorders

(Maercker and Znoj, 2010; Simon et al., 2007).

Despite discussions about the precise criteria for PGD, there is

an impressive amount of literature on treatment outcomes for

bereavement associated problems. In general, meta-analyses eval-

uating the efcacy of treatments for grief give small (Kato and

Mann, 1999: d0.11; Fortner, 2000: d0.13;Rosner et al., 2005:d0.20;Currier et al., 2008:d0.16) to medium (Allumbaugh and

Hoyt, 1999:d0.43) effect size (ES) calculations at best. However,

studies including only patients with severe grief symptoms

showed evidence of larger effect sizes than studies with subjects

that did not have substantial grief symptoms:Currier et al. (2008)

reported an ES ofd0.51, andRosner et al. (2005)reported an ES

of d0.27. The most recent meta-analysis compared preventive

and treatment interventions for PGD and found an ES of 0.03 for

prevention and 0.53 for treatment interventions (Wittouck et al.,

2011).

Studies based exclusively on patients meeting the criteria for

PGD are still rare. There are three successful randomized con-

trolled trials investigating individual treatment for PGD in terms of

overall ES: (1) a trial with two active conditions comparing

complicated grief treatment with interpersonal therapy (Shear et

al., 2005); (2) a trial comparing an internet-based intervention

with an untreated control (Wagner et al., 2006); and (3) a trial

comparing cognitive behavioural therapy (CBT) with supportive

counselling (Boelen et al., 2007). Because two of the studies

compared active treatments (Boelen et al., 2007; Shear et al.,

2005), it is reasonable to use the pre- to post-treatment effect

sizes to compare the respective treatment protocols. Boelen et al.

(2007) reported an ES of 1.36 for the combination of cognitive

restructuring followed by exposure and an ES of 1.80 for the

combination of exposure followed by cognitive restructuring.

Shear et al. (2005) reported an ES of 1.63, and Wagner et al.

(2006) reported an ES of 1.41 (the combined result for posttrau-

matic symptoms and symptoms of dysfunctional adaptation to

grief). All reported ES values are based on completer analyses.In all treatment protocols, patients with severe comorbid

disorders were excluded. Boelen et al. (2007) excluded severely

depressed patients, as well as patients with substance use dis-

orders, and provided no further information on additional diag-

noses. Shear et al. (2005)excluded patients with substance abuse,

psychosis, and bipolar disorder. However, 45% of patients in their

complicated grief treatment group met criteria for a current

depressive episode, and 49% of patients met criteria for PTSD. An

effectiveness study based on patients seeking inpatient treatment

showed an even wider range and higher number of comorbid

disorders (Rosner et al., 2011b). Therefore, under clinical condi-

tions, a high number of comorbid diagnoses should be expected.

The reduction of comorbid symptoms has not yet been covered in

depth. In regards to the studies mentioned above, Boelen et al.(2007) reported an ES of 1.18 measuring overall psychological

distress with the Dutch version of the SCL-90-R (Derogatis, 1977)

for the cognitive restructuring followed by exposure condition and

an ES of 1.15 for exposure followed by cognitive restructuring.

Shear et al. (2005)reported an ES of 1.22 for depression and 0.82

for anxiety.

To develop a successful intervention, we reviewed studies that

reported positive outcomes regarding their specic therapeutic

interventions. We also performed a meta-analysis on therapeutic

interventions by correlating them with symptom severity (Rosner

et al., 2005; Rosner and Hagl, 2007) to estimate the contribution of

PGD status to outcome. The most promising treatment strategies

were the following: psycho-education about normal and pro-

longed grief processes, exposure elements relating to the most

painful aspects of the loss, and transformation of the loss to enable

change. The study byBoelen et al. (2007)was not published at the

time our manual was developed. Furthermore, we identied other

promising interventions in our literature review, such as grief

resolution in a publication by Melges and DeMaso (1980) and

Rando's (1993)description of Gestalt and psychodrama interven-

tions. We decided to use exposure and cognitive interventions

similar to those described in two PTSD interventions: Ehlers's

manual on the treatment of PTSD in adults (Ehlers, 1999) andCohen and coworkers' manual (2006) on the treatment of PTSD

and grief in children. We included these elements in our newly

developed intervention for inpatients. The resulting structure and

selected interventions were then adapted for different settings. An

inpatient group treatment based on our manual showed a large

pre- to post-treatment ES of 1.21 for inpatients with comorbid

complicated grief (Rosner et al., 2011b).

Hence, the primary goal of this study was to evaluate the

efcacy of a specic individual outpatient treatment manual for

PGD, named integrative cognitive behaviour therapy for prolonged

grief (PG-CBT), in terms of improving patients' grief severity

compared to a wait list control group. Secondary goals were to

test whether PG-CBT is more effective in improving general

distress symptoms and comorbid symptoms compared with a

wait list control group.

2. Methods

2.1. Procedure

The study was approved by the university's ethics committee

and has been registered with Clinical Trials (Identier:

NCT01433653). Pilot patients were seen in 2005. Randomization

began in October 2006. The last patient nished therapy in June

2011. The study design is a stratied randomized controlled trial.

We stratied our sample according to the patient's relationship to

the deceased, namely, a child or other form of kinship, and

according to the type of death, namely, a natural or non-naturaldeath. A stratied randomization list was electronically produced

and provided by the university's Department of Statistics; then it

was transferred into four groups of envelopes (according to type of

death type of kinship) that contained group allocation. Alloca-

tion was not disclosed to patients or project workers before the

end of baseline assessment.

The control condition was a wait list. The waiting period was

set at four months or longer. This shortest possible waiting period

of four months was chosen for ethical reasons to avoid unneces-

sary suffering on the patients' part as well as for practical purposes

to ensure treatment adherence. Once a month during the waiting

period, patients met with the diagnostician, who had assessed the

patients' baseline, for ethical and safety reasons. These interim

sessions did not include any treatment; rather, these sessionsconsisted of informal safety check-ups, such as inquiring about

possible intentions of self-injurious behaviour or suicidal idea-

tions. None of the participants had to be excluded from wait list

because of respective clinical reasons. Treatment was offered as

soon as a therapist was available, but not before the minimum

waiting period of four months. On average, patients in the wait list

control group were re-assessed by their respective diagnostician

after six months of waiting (M6.04; SD1.36). Patients in the

treatment group were assessed at baseline by a diagnostician,

while later assessment was conducted by their respective thera-

pist. During the treatment, but not during the wait list period,

symptom questionnaires (PG-13 and SCL-90-R, see Measures

section below) were administered three times (along with addi-

tional process measures): (1) between sessions 5 and 7,

R. Rosner et al. / Journal of Affective Disorders 167 (2014) 5663 57


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(2) between sessions 10 and 12, and (3) between sessions 15

and 17.

2.2. Participants

Participants were recruited through word-of-mouth, from

referrals after personal meetings with other health care profes-

sionals or clergy, after presentations and letters to institutions and

counselling centres, as well as directly via newspaper articles,magazine articles, and radio interviews. Prospective patients called

the outpatient clinic at the Department of Psychology (Ludwig-

Maximilian-University of Munich, Germany) and were prelimina-

rily assigned to the study diagnostician if they mentioned that

they were calling because of a loss or if they answered positively to

the intake question: Did you lose a loved one, and is the loss still

disturbing you?A study diagnostician then invited patients to an

assessment. Patients had to meet the following inclusion criteria:

age 18 years or older, uent German language skills and literacy,

reasonable distance between the caller's residence/workplace and

the outpatient clinic (one hour maximum travelling time), and a

clinical diagnosis of PGD, that is the prevalence of clinically

signicant grief symptoms related to a death that occurred six

months prior at least. Clinical signi

cance was judged by thediagnostician's impression concerning distress and impairment

and in addition to information obtained from an interview on grief

symptoms (see Measures section). Exclusion criteria were acute

psychosis, severe substance dependence, suicidality, unstable use

of psychotropic drugs (i.e., medication had to be stable for at least

6 weeks), and concurrent psychotherapeutic treatment.

Altogether, 107 people called the outpatient clinic during the

designated trial period between 2006 and 2010. A total of 56

persons were not enroled, 20 of them because they rejected the

offer for treatment and 36 because they did not meet criteria; 27

of those who did not meet the study criteria did not receive a

clinical diagnosis of PGD (seeFig. 1for participantow and furtherreasons for exclusion). As a result, 51 persons were randomized

into the study (intent-to-treat sample; ITT); 24 were randomized

into PG-CBT and 27 into the wait list (WG).

A detailed description of the participants can be found in

Table 1. On average, participants were middle aged, ranging from

20 to 78 years. Most were female (86%) and lived without a

partner (67%). A comparison of treatment and wait list group

yielded signicant differences concerning only age and time since

loss (po0.05). The WG patients were signicantly older than

patients in PG-CBT,t(49)2.15,p0.037. The average time since

loss was marginally longer for participants in PG-CBT than in WG,

t(27.41)2.03, p0.052 (unequal variances assumed) which is

probably due to the wide range in PG-CBT (from a half year to 37

years). Most participants (86%) fullled diagnostic criteria for at

least one other disorder in addition to PGD when assessed for

symptoms within the last twelve months. On average, patients had

2.5 comorbid disorders (range 07), determined by a standardized

Assessed for eligibility (n = 107)

Excluded (n = 56)

Not meeting inclusion criteria (n = 36)

- No PGD diagnosis (n = 27)

- Insufficient language skills (n = 3)

- Currently in psychotherapy (n = 2)

- Acute substance dependence (n = 3)

- Acute psychosis (n = 1)

Declined to participate (n = 20)

Analyzed in ITT sample (n = 24)

Excluded from ITT-analysis (n = 0)

Analyzed in completer sample (n = 19)

Discontinued intervention (because of

relocation and other reasons) (n = 3)

Allocated to PG-CBT (n = 24)

Started treatment (n = 22)

Did not begin treatment (n = 2)

Lost to post assessment (n = 1)

Discontinued waiting period (n = 0)

Allocated to wait list (n = 27)

Started/completed wait list (n= 24)

Dropped out after allocation (n= 3)

Analyzed in ITT sample (n = 27)

Excluded from ITT-analysis (n = 0)

Analyzed in completer sample (n = 23)

Allocation

Analysis

Post-treatmentassessment

Randomized (n= 51)

Enrollment

Fig. 1. Participant ow.Note.PG-CBTintegrative cognitive behavioural therapy for prolonged grief; ITTintent-to-treat.

R. Rosner et al. / Journal of Affective Disorders 167 (2014) 566358


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clinical interview. In this study, we report only the disorders that

are often associated with PGD: major depressive disorder, PTSD,

generalized anxiety disorder, panic disorder, and two somatoform

disorders (somatization disorder and pain disorder) (seeTable 1).

2.3. Measures

The primary outcome measure was the severity score of the

Interview for Prolonged Grief-13 (PG-13; Prigerson andMaciejewski, n.d.;Prigerson et al., 2009), which was obtained by

calculating the sum of the 11 symptom item scores (range: 1155

points). The 13 items of the PG-13 roughly correspond to the

consensus criteria for PGD proposed by Prigerson et al. (2009):

criterion B (separation distress), criterion C (cognitive, emotional,

and behavioural symptoms), criterion D (duration), and criterion E

(impairment). However, criterion F (medical exclusion) and criter-

ion G (relation to other mental disorders) were not explored by the

instrument. The German version of the PG-13 was translated by

(Pfoh 2007; Rosner et al., in press). The PG-13's psychometric

evaluation showed adequate reliability in the literature; a Cron-

bach's alpha value of.76 was reported in a study by Schaal et al.

(2009). However, the PG-13 was less reliable in our sample, with

0.53 (N51), which might be explained by the fact that we

studied an especially homogenous sample with rather severe

symptoms. However, the post-assessment reliability was ade-

quate, with 0.89 (n42). For the three assessment points

during treatment, a self-report version of the PG-13 was adminis-

tered (Prigerson and Maciejewski, n.d.).

Improvement in general psychopathology was assessed using

the Symptom Checklist-90-Revised (SCL-90-R; Derogatis, 1977;

German version: Franke, 2002), a widely used self-report ques-

tionnaire measuring psychological distress during the last seven

days. In addition to the SCL-90-R's nine subscales, a global severity

index (GSI) can be calculated. The GSI measures the intensity of

global mental health distress and was used as a secondary out-

come measure, along with the subscale scores covering depres-

sion, anxiety, phobic anxiety, and somatization. These subscales

were selected because they correspond to comorbid diagnosesfrequently found in our sample. The SCL-90-R was administered

pre-treatment, post-treatment, and three times during treatment.

To assess comorbidity at baseline, the 12-month prevalence

rates of disorders commonly associated with PGD were assessed

using the respective sections of the Computerized Diagnostic

Interview for DSM-IV (DIA-X; Wittchen and Pster, 1997). The

DIA-X is a standardized interview used to obtain DSM-IV diag-

noses. The respective sections of the DIA-X were repeated after the

treatment or waiting period. Further measures were also used for

explorative reasons (e.g., posttraumatic growth) and as process

measures (e.g., concerning therapeutic alliance); however, they

will be covered elsewhere.

2.4. Intervention

As described above, PG-CBT is based on the results of a

literature review. PG-CBT has been adapted to the standard health

insurance coverage for outpatient mental health treatments in

Germany, which allows for 25 sessions. Of those 25 sessions, ve

are optional and are directed towards special situations or critical

occasions, such as anniversaries, holidays, family sessions, or legal

proceedings/court days. The remaining 20 sessions compose the

standard treatment for all patients and are divided into three

parts. Part one consists of seven sessions that focus on stabilizing

and motivating the patient as well as on further exploration of the

patients' grief situation; part two consists of nine sessions, rst

teaching relaxation, then focusing on confrontation and reinter-

pretation of the cognitions and perceptions related to patients

themselves, their deceased loved ones and the circumstances of

death; part three consists of four sessions, focusing on future

prospects while maintaining a healthy bond to the deceased.

Sessions were prescribed weekly lasting 50 min each, with the

exception of two 90 min sessions. Therefore, the treatment can be

completed within ve to six months; however, in most cases, the

duration of treatment was nine months (mode value) or longer,

M11.53 (SD2.89). Treatment frequency was adapted to the

personal circumstances of the participants; the usual reasons fortreatment prolongation were illness, vacation, or new losses. As a

result, the time between pre- and post-treatment assessment

differed signicantly between PB-CBT and WG, t(24.54)7.59,

po0.001.

Therapists were two master's degree level psychologists (G.P.

and M.K.); these therapists were trained in the application of the

manual by an experienced CBT psychotherapist (R.R.), who also

had seen some of the pilot patients. During the pilot phase, the

manual was rened, adapted, and made available as a written

protocol afterwards. Therapists received biweekly supervision to

ensure treatment delity. Most therapy sessions were recorded on

audiotape (depending on patients' permission), and selected

recordings were discussed during supervision. Both therapists

were female, had an average age of 40 years, and worked as

therapists for an average of 10 years. At that time they were not

yet certied according to German regulations. A short description

of the treatment can be found in Rosner et al. (2011a).

2.5. Data analyses

Possible differences concerning demographic data and baseline

scores between the conditions, as well as between treatment

completers and non-completers, were examined with chi-square

tests and independent t-tests. We performed both intent-to-treat

(ITT) and completer analyses. For the ITT analyses, we carried the

last available observation forward in cases of missing data. When

analyzing treatment length, the actual length between the pre-

treatment assessment and the last observation was used (i.e., a

score of 0 was obtained in cases where a missing post-treatment

score was substituted with the pre-treatment score because of

immediate dropout). Between-group changes were analyzed using

univariate ANCOVAs, with pre-treatment scores as covariate.

Within-group changes were analyzed with paired-sample t-tests.

Effect sizes for within- and between-group changes were calcu-

lated using Cohen's d. Partial eta-squared (2) for each ANCOVA

was also calculated, reecting the portion of variance explained

by the treatment factor after controlling for pre-treatment scores.

For 2, results larger than 0.14 are considered large effects.

Clinical signicance was evaluated following Jacobson and

Truax (1991), combining their cut-off Awith the reliable change

index (RCI). To calculate the RCI, the Cronbach's alpha value from

baseline was used. Following that denition, subjects who reliably

improved and were over the calculated cut-off for signicantchange at post-treatment (i.e., an improvement more than two

standard deviations above the average score at pre-treatment)

were considered recovered.

3. Results

3.1. Completion and baseline differences

Three out of the 27 participants dropped out of WG (11%)

immediately after allocation; another participant completed the

waiting time, but parts of the data at post-treatment assessment

are missing. Five out of the 24 allocated participants in PG-CBT

dropped out during treatment (21%): two did not start treatment,



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one completed only one session, and two dropped out after seven

respectively nine sessions. Two patients did not complete post-

treatment assessment, but were still considered completers: one

patient nished after 18 treatment sessions, and the other com-

pleted the full 25 sessions. Of the other treatment completers, onepatient nished after 22 sessions, and one nished after 24; all

others received 25 sessions. Therefore, on average, treatment

completers received 24.42 sessions (SD1.71). Treatment com-

pleters and drop-outs were compared on all variables reported in

Table 1as well as on the baseline data of the PG-13 and SCL-90-R.

The 19 completers and 5 drop-outs differed in only one variable;

much more time had passed between the loss and study intake in

completers (M8.67 years,SD10.06) than in drop outs (M1.17

years; SD0.85), t(18.93)3.21, p0.005 (unequal variances

assumed). However, this might have been due to a large range in

completers (6 months to 36 years vs. 6 months to 2.5 years in

drop outs).

Concerning outcome measures there were no differences in

baseline scores according to group neither in the original ITTsample nor the completer sample.

3.2. Main outcomes

For the ITT analysis, the univariate ANCOVA yielded a signi-

cant and large effect (d1.32) of PG-CBT in comparison with WG

on the primary outcome measure, grief assessed with the PG-13

(seeTable 2). The same is true for the completer analysis (d1.61,

seeTable 3). In addition to the results provided in Tables 2 and 3,

we computed simple pre- to post-treatment comparisons. In PG-

CBT, results were highly signicant and showed large effects,

t(23)5.22, po0.001, d1.26, for the ITT analysis and t(18)

6.35,po0.001,d1.65, for the completer analysis. PG-13 scores in

WG did not change signicantly,t(26)0.65,p0.520,d0.10, for

the ITT analysis and t(22)0.65, p0.522, d0.12, for the com-

pleter analysis.

3.3. Secondary outcomes

Concerning the secondary outcome measures, the SCL-90-R

(GSI and subscales), the improvements pre- to post-treatment

were less pronounced. In the ITT analysis, global mental health

distress as assessed by the GSI still improved signicantly with

PG-CBT, t(23)3.50, p0.002, d0.64, while no improvement

was seen in WG, t(26)1.57, p0.129, d0.20. However, the

univariate ANCOVA showed no signicant effect (Table 2). The

same holds true for completers (Table 3). The within-group

Cohen'sd was nearly the same as in the ITT analysis, t(17)3.36,p0.004,d0.68. Again, the pre- to post-treatment comparison in

WG was not signicant, with a small effect, t(22)1.25,p0.226,

d0.17.

To get a closer look at what types of symptoms, other thangrief, improved for PG-CBT patients, we tested four SCL-90-R

subscales (somatization, depression, anxiety, and phobic anxiety)

in a series of univariate ANCOVAs. In both the ITT and completer

analyses, depression improved signicantly more in PG-CBT com-

pared with WG, with moderate to large effects (see Tables 2 and

3). With the exception of phobic anxiety, within-group changes in

PG-CBT were signicant in the ITT analysis, at least with an alpha

level ofpo0.05 (tests not shown). In the completer analysis, only

somatization and depression improved signicantly. Pre- to post-

treatment effect sizes (Cohen's d) were all within the moderate

range (0.42 to 0.68). None of these subscales improved signi-

cantly in the WG. Because four statistical tests were performed for

each of the comparisons (controlled vs. uncontrolled; ITT vs.

completer), alpha ination should be considered. Bonferroni

Table 1

Demographic and clinical characteristics of the intent-to-treat sample.

Total sample

(N51)

PG-CBT

(n24)

WG

(n27)

Female gender 44 (86%) 20 (83%) 24 (89%)

Age in years, M(SD) 47.53 (14.72) 43.0 (13.0) 51.56

(15.22)

Marital status

Single 17 (33%) 10 (42%) 7 (26%)

Married/partnered 17 (33%) 8 (33%) 9 (33%)

Divorced/separated 7 (14%) 4 (17%) 3 (11%)

Widowed 10 (20%) 2 (8%) 8 (30%)

Type of relationship to deceased

Child 15 (29%) 7 (29%) 8 (30%)

Other 36 (71%) 17 (71%) 19 (70%)

Type of death

Natural 31 (61%) 17 (71%) 14 (52%)

Non-natural 20 (39%) 7 (29%) 13 (48%)

Years since loss, M(SD) 4.93 (7.08) 7.10 (9.43) 3.01

(3.10)

Comorbid disorders a

At least one other disorder 86% 83% 88%

Number of comorbid disorders,

M(SD)

2 .5 2 (1.73) 2 .5 4 (1. 89 ) 2 .5 0

(1.61)Major depressive disorder 31 (62%) 15 ( 62%) 16 (62%)

Postt raum atic stress disorder 11 (22%) 6 ( 25%) 5 (19%)

Generalized anxiety disorder 7 (14%) 5 (21%) 2 (8%)

Panic disorder 12 (24%) 8 (33%) 4 (15%)

Somatoform disorders 27 (54%) 12 (50%) 15 (58%)

Note. Comorbid disorders are 12-months prevalences. PG-CBT Integrative cogni-

tive behavioural therapy for prolonged grief; WGwait list group;a n50 in the total sample and n26 in WG (one person in WG was not

assessed formally for comorbid disorders).

Table 2

Intent-to-treat analyses: means (SD) at pre- and post-treatment for PG-CBT ( n24)

and wait list (n27), controlled comparison.

PG-CBT WG Group-

time

Between

group ES

M(SD) M(SD)) F 2 d

PG-13 23.60nnn 0.33 1.32

Pre 41.17 (5.75) 42.63 (5.05)Post 30.71 ( 10.19) 42.07 (6.58)

SCL-90-R

Global severity

index

2.84 0.06 0.33

Pre 1.24 (0.60) 1.23 (0.77)

Post 0.86 (0.58) 1.08 (0.75)

Somatization 0.23 0.01 0.09

Pre 1.26 (0.75) 1.24 (0.97)

Post 0.93 (0.73) 1.00 (0.86)

Depression 7.79nn 0.14 0.73

Pre 1.68 (0.85) 1.89 (0.85)

Post 1.18 (0.76) 1.78 (0.88)

Anxiety 1.32 0.03 0.23

Pre 1.16 (0.69) 1.15 (1.00)

Post 0.78 (0.77) 0.96 (0.78)

Phobic anxiety 1.43 0.03 0.46

Pre 0.65 (0.70) 0.91 (0.96)

Post 0.39 (0.52) 0.75 (0.97)

Note. PG-CBTIntegrative cognitive behavioural therapy for prolonged grief;

WGwait list group; PG-13Interview for Prolonged Grief-13; SCL-90-R

Symptom Checklist-90-Revised.nn po0.01.nnn po0.001.



6/8

correction would result in setting the alpha level at p0.013. Evenin this case, the effect is still seen for depressive symptoms.

3.4. Clinically relevant improvement

In terms of clinically relevant improvement in symptoms of

prolonged grief, the cut-off for clinically signicant improvement

at post-treatment assessment was set at a score of 31 on the PG-

13. FollowingJacobson and Truax's (1991)two-step criterion, 42%

of PG-CBT completers (n8) were considered to be recovered (i.e.,

they were below the cut-off and showed a statistically reliable

improvement) versus only 4% (n1) in WG, 2 (1)8.81,p0.003.

In terms of reliable change, 53% (n10) of the PG-CBT completers

improved versus only 4% (n1) in WG, 2 (1)12.55, po0.001.

Two participants showed a reliable improvement but did not meetthe cut-off value (i.e., they had a score above 31 at post-treatment

assessment). Likewise, there were two other participants who met

the cut-off criterion at post-treatment assessment, but had begun

with a rather low score, so that they could not achieve reliable

improvement. Participants did not deteriorate reliably in either the

PG-CBT group or WG.

4. Discussion

The present ndings suggest that our treatment for PGD is

highly effective in terms of reducing grief severity. The controlled

ES for grief symptom improvement in PG-CBT completers is

d1.61; compared with the ES values reported in meta-analyses

for patients with strong therapy indications (Currier et al., 2008:d0.51; Rosner et al., 2005: d0.27; Wittouck et al., 2011:

d0.53), our intervention seems to be considerably more effective

than grief interventions in general. Furthermore, the results are

similar to other effective treatment protocols for PGD. As control

conditions did vary substantially between trials, we focus on pre-

to post-treatment ES when comparing our study with other

randomized controlled trials. Regarding grief symptom scores,

Boelen et al. (2007) reported a pre- to post-treatment ES of 1.36for the combination of cognitive restructuring followed by expo-

sure and an ES of 1.80 for the combination of exposure followed by

cognitive restructuring.Shear et al. (2005)reported a pre- to post-

treatment ES of 1.63, andWagner et al. (2006) reported an ES of

1.41 (when results for posttraumatic symptoms and symptoms of

dysfunctional adaptation to grief were combined). With a pre- to

post-treatment ES of d1.65 and a 42% clinically signicant

improvement in terms of the conservative two-step criterion of

Jacobson and Truax (1991), PG-CBT compares well to other

treatments for PGD. However, these studies achieved their results

in less time and with a smaller treatment dosage. Considering that

Jacobson and Truax's reliable change index requires a larger

improvement when the outcome instrument has low reliability

(as is the case with baseline scores of the PG-13), our results for

clinical signicant improvements are conservative indeed and

would have proted from using a more reliable measure.

Regarding self-reported comorbid symptoms, the pre- to post-

treatment ES values for general mental health distress were

moderate and the controlled comparison was signicant only for

depressive symptoms. Overall, when comparing the ES values for

depression and anxiety with the results fromBoelen et al. (2007),

improvements noted in our study seem less pronounced. However,

in our sample, variances in self-reported comorbid symptoms

were rather large, meaning that there were some patients who

had very low symptom scores initially, especially concerning

phobic anxiety. In some cases, there might not have been much

room for improvement.

In terms of completion rates, the results in our study are good,

with 79% completion in PG-CBT versus 73% in the study by Shearet al. (2005)and 71% in the study by Boelen et al. (2007).

4.1. Strengths and limitations

The main strength of this trial is that it followed a randomized

controlled design with stratication according to two important

variables (relationship to the deceased and type of death).

Furthermore, it was conducted in a naturalistic clinical setting,

as the university's outpatient clinic is part of the local mental

health system. Study participants experienced conditions compar-

able to regular outpatient treatment, with the exception of

possibly being randomized into a wait list and a more thorough

diagnostic process. The study was not funded and therefore

followed the clinical practice conditions in Germany. Exclusioncriteria were not overly strict and followed clinical considerations:

acute psychosis, severe substance abuse, and/or suicidality would

preclude outpatient therapy with exposure elements in any case.

Apart from those conditions, patients showed high levels of

comorbidity according to a structured clinical interview. These

strengths regarding the generalizability to clinical practice are,

however, met with several weaknesses that limit the interpreta-

tion of the results. First and foremost, time between pre- and post-

treatment assessments in the treatment group was nearly twice as

long compared to the wait list group. For ethical reasons, as well as

to prevent treatment drop-out, the waiting period had been set to

four months; however, the PG-CBT protocol could not be com-

pleted in less than ve or six months. In reality, PG-CBT often took

longer, nearly a year on average, while the waiting period lasted

Table 3

Completer analyses: Means (SD) at pre- and post-treatment for PG-CBT ( n19) and

waitlist (n23), controlled comparison.

PG-CBT WG Group time Between group

ES

M(SD) M(SD) F 2 d

PG-13 34.03nnn 0.47 1.61

Pre 41. 21 (6. 03 ) 41.7 8 (4. 63)Post 28 .05 (9. 51 ) 41.13 (6. 42)

SCL-90-R a

Global

severity

index

3.63 0.09 0.33

Pre 1.28 (0.64) 1.21 (0.81)

Post 0.85 (0.63) 1.08 (0.75)

Somatization 0.42 0.01 0.13

Pre 1.32 (0.74) 1.29 (1.02)

Post 0.90 (0.71) 1.01 (0.91)

Depression 7.44nn 0.16 0.60

Pre 1.74 (0.89) 1.80 (0.83)

Post 1.15 (0.84) 1.66 (0.86)

Anxiety 1.26 0.03 0.29

Pre 1.16 (0.71) 1.21 (1.02)Post 0.76 (0.79) 0.99 (0.78)

Phobic

anxiety

1.06 0.03 0.33

Pre 0.76 (0.75) 0.91 (0.99)

Post 0.44 (0.58) 0.71 (0.99)

Note. PG-CBTintegrative cognitive behavioural therapy for prolonged grief;

WGwaitlist group; PG-13Interview for Prolonged Grief-13; SCL-90-

RSymptom Checklist-90-Revised.a For the SCL-90-R in PG-CBT n at post-treatment is 18 because one person did

not complete the SCL-90-R (which means that ANCOVAs for Global severity index

and the SCL-90-R subscales are based on 41 cases).nn po0.01.nnn po0.001.



7/8

for an average of six months. Therefore, one could argue that the

PG-CBT completers improved signicantly more than waiting list

participants only because they had more time to improve. How-

ever, given the rather long duration of time since loss, and

therefore the chronicity of their symptoms, such an argument

seems rather unlikely. Second, post-treatment assessment was not

blinded; for practical reasons, it was performed by the respective

therapist. Finally, we computed no power analysis in advance and

the sample size was small; furthermore only a few male patientswere treated. Therefore, these results should be regarded as being

preliminary.

4.2. Clinical implications and conclusions

We reported on a broader range of comorbid diagnoses than in

previous treatment trials; our results show that PGD patients have

a high degree of comorbidity. Although results on comorbidity are

not directly comparable between studies because the diagnostic

procedures varied, studies performed to date appear to show a

high comorbidity with depression and anxiety disorders as well as

with PTSD; for the latter diagnosis, we found a markedly lower

prevalence than Shear et al. (2005). In our study, somatoform

disorders were surprisingly prevalent. Somatization symptomsshould be assessed in future studies.

PG-CBT showed less pronounced improvement in comorbid

symptoms than the treatments in the study by Boelen et al.

(2007); this may be due to specic sample characteristics, such

as other comorbidity patterns. However, PG-CBT proved to be as

effective as other treatments in the designated target syndrome,

prolonged grief. Together with the results ofRosner et al. (2011b),

where this approach was evaluated in a very different setting

(group format with inpatients), these ndings are encouraging

enough to warrant further study. On a broader scope, this trial

once again showed that PGD is a useful diagnostic entity that can

be specically targeted, supporting the validity of PGD. Conse-

quently, our results suggest that it is useful to screen for PGD and

provide a specic grief treatment protocol in clinical settings

where patients are admitted for various disorders.

Role of funding source

The actual therapy hours were compensated through the health insurance

system. The study itself has not been funded.

Conict of interest

None of the authors has any conict of interest.

Acknowledgement

None.

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Duelo Prolongado y CBT

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