SafeSteps

"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 1) 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, 2) to replicate and expand on preliminary results on the effectiveness of sertraline (Zoloft™) for a dually-diagnosed population, and 3) to examine the question of whether the combination of these two interventions will improve efficacy above and beyond the impact of both individual treatments.

This NIAAA funded clinical trial uses a randomized, double-blind, repeated measures design to evaluate the efficacy of Seeking Safety (SS) in combination with an anti-depressant medication (Zoloft) in reducing alcohol use, PTSD severity and psychiatric symptoms over time. Eligible female participants are randomly assigned to one of two conditions (Seeking Safety plus Zoloft or Seeking

As in our original Treatment Outcomes for Cocaine Dependent Women Study, 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.