"Combined Treatments for Women With PTSD and Alcohol Use Disorders"

(Funded by NIAAA)

In the past few years there has been a growing effort to develop effective interventions that target patients diagnosed with both substance abuse and PTSD. Though preliminary findings demonstrate the strong potential of cognitive-behaviorally oriented approaches and of antidepressant medication for this population, to date there are no known controlled studies which examine the efficacy of combining these two promising active ingredients.

This study aims to replicate and expand on pilot studies demonstrating the effectiveness of a manualized cognitive-behavioral treatment specifically designed for women with comorbid substance use disorders and PTSD, "Seeking Safety" (L. Najavits, in press), to replicate and expand on preliminary results on the effectiveness of sertraline (Zoloft™) for a dually-diagnosed population, and to examine the question of whether the combination of these two interventions will improve efficacy above and beyond the impact of both individual treatments.

Our randomized four-armed clinical trial will assess the relative efficacy of Seeking Safety plus placebo, Seeking Safety plus sertraline, nonspecific "treatment as usual" plus placebo, and treatment as usual plus sertraline, in treating inner-city women with alcohol dependence and comorbid PTSD over a three month period with repeated measures at baseline, completion of treatment, and 3-months post-treatment.

As in our original PTSD Treatment Outcomes for Women with Cocaine Use Disorders, the specific outcomes to be examined in the study are efficacy in: (1) reducing drug and alcohol use; (2) maintaining retention rates in substance abuse treatment; (3) reducing psychiatric symptoms of PTSD and other trauma-related conditions; and (4) reducing HIV risk behavior. We aim to assess the impact of potential predictors (including baseline severity of substance use, PTSD, depression and intensity of other services received) on substance use and PTSD symptomatology over follow-up. We will also explore the impact of potential mediators, representing acquisition of intervention components, on substance use and PTSD symptomatology over the two assessment periods.

This study has the particular advantages of (1) building directly on preliminary positive empirical findings by further testing both a manualized treatment specifically designed for dually-diagnosed women and sertraline treatment, and (2) uniquely assessing the novel combination of these two promising treatments in a controlled clinical trial to explore if there is an additive effect which can improve treatment outcome rates for this population.