Evidence-based treatments for depression have rarely been studied in community settings where low income and ethnic minority patients receive care. Among the most in need of effective treatments are depressed women with histories of early interpersonal trauma, who suffer disproportionate burden characterized by chronic depression, multiple comorbidities, and marked interpersonal difficulties.
The aim of the proposed randomized controlled trial (RCT), based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS). IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings. Substantial pilot data providing preliminary support for IPTTCS and supporting the feasibility of the proposed RCT have been collected during the P.l.'s NIMH-K23 Career Development Award. An ongoing pilot RCT of IPT-TCS has demonstrated high rates of patient recruitment and acceptance of randomization. The proposed RCT (n=180) will compare IPT-TCS to treatment as usual (TAU) for women with major depression and histories of childhood sexual abuse. A hybrid efficacy-effectiveness design will be used. Urn randomization procedures will balance groups with respect to medication status;active post-traumatic stress disorder (PTSD);active anxiety disorder other than PTSD;fully-remitted substance use disorders;and, borderline personality disorder. Medication dosage and adherence, medication management visits, and case management visits will not be controlled by design, but will be controlled statistically in secondary analyses. We hypothesize that IPT-TCS will be more effective than TAU in reducing depression at 32-weeks after treatment assignment. Improvements in social functioning, health-related functioning, post-traumatic stress symptoms, and mental health functioning are also expected. To monitor post-treatment course, outcome variables will be assessed at 6-month intervals over a 2-year period, and longer-term effects will be examined via repeated-measure analyses. The proposed research is designed to provide definitive results regarding the effectiveness of IPT-TCS compared to usual care in a community mental health center. The next stage of our research program will be directed at transporting IPT-TCS and comparison therapies into community agencies.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH076928-05
Application #
8100395
Study Section
Special Emphasis Panel (ZMH1-ERB-P (03))
Program Officer
Rudorfer, Matthew V
Project Start
2007-09-14
Project End
2013-05-31
Budget Start
2011-06-01
Budget End
2013-05-31
Support Year
5
Fiscal Year
2011
Total Cost
$440,826
Indirect Cost
Name
University of Rochester
Department
Psychiatry
Type
Schools of Dentistry
DUNS #
041294109
City
Rochester
State
NY
Country
United States
Zip Code
14627
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Cankaya, Banu; Talbot, Nancy L; Ward, Erin A et al. (2012) Parental sexual abuse and suicidal behaviour among women with major depressive disorder. Can J Psychiatry 57:45-51
Cort, Natalie A; Gamble, Stephanie A; Smith, Phillip N et al. (2012) Predictors of treatment outcomes among depressed women with childhood sexual abuse histories. Depress Anxiety 29:479-86
Gamble, Stephanie A; Smith, Phillip N; Poleshuck, Ellen L et al. (2011) Domain-specific social functioning improvements during treatment of depressed women with histories of childhood sexual abuse. J Affect Disord 130:478-82
Talbot, Nancy L; Chapman, Ben; Conwell, Yeates et al. (2009) Childhood sexual abuse is associated with physical illness burden and functioning in psychiatric patients 50 years of age and older. Psychosom Med 71:417-22