1. 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

2. Abstract Low income minority women with major depression (MDD) were recruited for a depression treatment trial in primary care settings serving low-income patients. They were randomized to CBT, medication (usually SSRI), or treatment as usual (referral only, TAU), evaluated by baseline clinical interview, and followed by telephone for one year. PTSD was reassessed at one year. Six month data were available on 267 women. 44% were African American and 50% Latina, 37% had less than a high school education, and 65% were uninsured. 48% of the sample had current co-morbid PTSD. Both treatment groups showed significant improvement in depression symptoms and social functioning during the first 6 months, compared to TAU, with no differences by ethnicity or PTSD comorbidity status. At one year, CBT subjects without PTSD were significantly less depressed than TAU subjects, but those with comorbid PTSD did not Differ from TAU. There were no significant depression differences for medication. However, medication subjects with PTSD at baseline were significantly less likely to have PTSD at one year. Treatment did not affect exposure to new traumas.

3. 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

4. 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, and White women recruited in local clinics in the Washington DC area (Miranda, Chung, Green, Krupnick, et al., 2003)

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 3 & 6 Mo. Depression Outcomes: Adjusted mean HDRS scores Meds (p<.0001) CBT (p=.002) Meds (p<.0001) CBT (p=.002)

15. 3 & 6 Mo. Social Functioning: Adjusted SF-36 Scores Meds (p<.001) CBT (p=.01) Meds (p<.001) CBT (p=.01)

16. 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

17. 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

18. 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

19. Changes in PTSD Severity for Women with PTSD at Baseline

20. 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

21. 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

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

23. 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.