ONE YEAR PTSD OUTCOMES IN A DEPRESSION TREATMENT TRIAL

Bonnie Green, Janice Krupnick, Joyce Chung, Juned Siddique*,

& Jeanne Miranda*

Department of Psychiatry Georgetown University

* Now at UCLA

AbstractLow income minority women with major depression (MDD) were recruited for adepression treatment trial in primary care settings serving low-income patients.They were randomized to CBT, medication (usually SSRI), or treatment asusual (referral only, TAU), evaluated by baseline clinical interview, and followedby telephone for one year. PTSD was reassessed at one year. Six month datawere available on 267 women. 44% were African American and 50% Latina,37% had less than a high school education, and 65% were uninsured. 48% ofthe sample had current co-morbid PTSD. Both treatment groups showedsignificant improvement in depression symptoms and social functioning duringthe first 6 months, compared to TAU, with no differences by ethnicity or PTSDcomorbidity status. At one year, CBT subjects without PTSD were significantlyless depressed than TAU subjects, but those with comorbid PTSD did notDiffer from TAU. There were no significant depression differences formedication. However, medication subjects with PTSD at baseline weresignificantly less likely to have PTSD at one year. Treatment did not affectexposure to new traumas.

Introduction

• Trauma, major depression, and PTSD impose a high individual burden of suffering and disability (Murray & Lopez, 1996; Solomon & Davidson, 1997)

• Ethnic minority patients are less likely to obtain appropriate care for mental disorders than are Whites, in part due to lack of insurance (USDHHS, 2001)

• In this study, we evaluated whether interventions that promote guideline concordant treatments for depression among young, predominantly minority women would improve rates of appropriate care and clinical outcomes

• Since about half of the women recruited to the treatment trial had co-morbid PTSD, we were able to evaluate the impact of these treatments on PTSD in low-income, mostly minority, patients

• This project involved a randomized clinical trial of depression treatment comparing

– Cognitive Behavioral Therapy (CBT) – Medication (MED)– Treatment as Usual (TAU)

in low income African American, Latina, andWhite women recruited in local clinics in the Washington DC area (Miranda, Chung, Green,

Krupnick, et al., 2003)

Method

• Subjects– 267 women with current major depressive disorder (MDD)

• 117 Black (44%)• 134 Latina (born in Latin America)(50%)• 16 White (6%)

– Recruited in WIC and family planning clinics– 48% met full criteria for current PTSD

• Treatment provided on site at clinics by psychologists (CBT) and nurse practitioners (MED)

• English & Spanish screening, evaluation, and treatment• Transportation and baby-sitting provided

Medication Intervention

• Treated by primary care nurse practitioners supervised by a board certified psychiatrist

• First line medication was paroxetine (Paxil) followed by buproprion (Wellbutrin) if intolerant or no response by HDRS score

• Mean paroxetine dose was 30mg• Six-month course of medication• Seen q 2-4 weeks, weekly phone contact

Cognitive-Behavioral Therapy

• Treated by psychologists trained in CBT• Used manual adapted for low-income English

and Spanish speaking patients• 8 weekly group or individual sessions focusing

on cognitive management of mood, engagement in pleasant activities and improving relationships

• Re-treatment w/ 8 sessions if not improved

Usual Care

• Educated about depression and mental health treatment available in the community

• Referral list given• Help offered to make appointments, call

providers, give clinical information• Followed and assessed by monthly phone calls

for first 6 months and every other month thereafter

Main Study Measures

• Screening: PRIME-MD – mood disorders section• Depression Diagnosis: Composite International

Diagnostic Interview (CIDI ) • Depression Symptom severity: Hamilton Rating

Scale for Depression (HDRS)• Trauma History: Stressful Life Events Screening

Questionnaire (Goodman et al., 1998)• PTSD Diagnosis: SCID (Baseline and 1 Year)• PTSD Severity: Count of PTSD symptoms• Social Functioning: SF-36

Results

Demographic Information– Mean age 29.3 (SD 7.9)– 37% Less than high school education

– 46% Married/partnered– 34% Never married

– 65% Uninsured– 15% Medical assistance

Trauma & Comorbid PTSD

• Study subjects reported 6 lifetime traumatic events, on average – Over 1/3 raped &/or experienced child abuse– Almost 1/2 domestic violence

• Current comorbid PTSD was diagnosed in 48% of those with MDD

Baseline Characteristics

• HDRS – Mean score 16.9 (SD 5.2)

• Atypical symptoms of depression common– Hamilton modified to include these symptoms– Atypical depression rate of 29%

• 81% had at least one comorbid anxiety disorder• 33% had two or more anxiety disorders

Participation in Care

• Medication treatment– 18 (20%) switched to buproprion– 66 (75%) received 9 or more weeks of meds– 40 (45%) guideline concordant care – 24 weeks

• CBT treatment– 15 (17%) received additional 8 sessions– 46 (53%) received 4 or more total sessions– 32 (36%) received 6 or more total sessions

3 & 6 Mo. Depression Outcomes:Adjusted mean HDRS scores

0

2

4

6

8

10

12

14

16

MED CBT TAU

Month 1Month 3Month 6

Meds (p<.0001)

CBT (p=.002)

Meds (p<.0001)

CBT (p=.002)

3 & 6 Mo. Social Functioning:Adjusted SF-36 Scores

0

10

20

30

40

50

60

70

80

90

MED CBT TAU

Month 0Month 3Month 6

Meds (p<.001)

CBT (p=.01)

Meds (p<.001)

CBT (p=.01)

6 Month Outcomes by PTSD Status

• Hypothesis: women with comorbid PTSD would improve more slowly, or treatment would be less effective, than for women with MDD

• No significant differences in mean depression score changes between subjects with comorbid PTSD at 6 months compared to subjects with MDD alone

• SF-36 social functioning improved for all subjects regardless of PTSD comorbidity

I Year Findings• 211 Women received a 12 month phone follow-

up (HAM-D and SF-36)• 168 Women were interviewed in person (PTSD)

at 1 Year• No treatment effects for social functioning • HAM-D severity at 1 Year (all subjects):

– CBT (but not MED) more successful than TAU for those patients without comorbid PTSD (p=.054)

– For patients with PTSD, no differences between treatments (CBT and MED) and TAU

For Women with PTSD at baseline (n = 74)– MED subjects were 3 times less likely to have

PTSD at 1 year than TAU subjects (p=.054). – There was a slightly stronger effect for those

women who received an adequate “dose” of MED treatment (p=.045).

– There were no differences between CBT and TAU

Changes in PTSD Severity

for Women with PTSD at Baseline

0

2

4

6

8

10

12

MED CBT TAU

PTSD SeverityBaseline

PTSD Severity 1 Year

Discussion• CBT and MED for MDD were effective for low-

income minority women, especially at 6 months post-treatment

• Most women showed significant improvements in depressive symptoms and social functioning

• Intervention included intensive outreach, childcare and transportation

• Few of the women in TAU engaged in the mental health care available in the community

• No ethnic differences in response to care were found

Findings for PTSD• There were no 6-month differences in outcomes

associated with comorbid PTSD• At one year, women who received depression-

focused CBT did better than TAU ONLY if they did not have comorbid PTSD

• At 1 Year, individuals with PTSD at baseline who were treated with medication, usually an SSRI (Paxil), were doing significantly better re: PTSD symptoms compared to usual care

Caveat: CBT in this study was for Depression, not for PTSD

Acknowledgement

This study was funded by Grant # RO1 MH 56864 to Jeanne Miranda

References• Goodman, L., Corcoran, C., Turner, K., Yuan, N., & Green, B.L. (1998).

Assessing traumatic event exposure: General issues and preliminary findings for the Stressful Life Events Screening Questionnaire. Journal of Traumatic Stress, 11,521-42.

• Miranda, J, Chung, JY, Green, BL, Krupnick, J, Siddique, J, Revicki, DA & Belin, T. (2003). Treating depression in predominantly low-income young minority women: A randomized controlled trial. Journal of the American Medical Association, 290, 57-65.

• Murray, CJ, & Lopez, AD. (1996) Evidence-based health policy: Lessons from the Global Burden of Disease Study. Science, 274, 740-743.

• Solomon, SD & Davidson, JRT (1997). Trauma: Prevalence, impairment, services use, and cost. Journal of Clinical Psychiatry, 58 (suppl 9), 5-11.

• United States Department of Health and Human Services. (2001). Mental health: Culture, race, and ethnicity – A supplement to mental health: A report of the Surgeon General. Rockville, MD: U.S. Departments of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Mental Health Services.