Feasibility, preliminary efficacy, and safety of a randomized clinical trial for Asian Women's Action for Resilience and Empowerment (AWARE) intervention.

To our knowledge, Asian Women's Action for Resilience and Empowerment (AWARE) is the first gender-and culture-specific and trauma-informed group psychotherapy intervention designed for Asian-American young women with histories of interpersonal violence and trauma and/or Post-Traumatic Stress Disorder (PTSD) diagnosis. We employed a 2-arm randomized controlled trial. Sixty-three women who met clinical criteria for trauma were randomized to the intervention (n = 32) or waitlist control (n = 31) group. We documented retention rates, preliminary efficacy for sexual risk behaviors and depressive symptoms (overall and stratified by PTSD at baseline), and safety in terms of suicidality at baseline, postintervention, and 3-month follow-up. AWARE demonstrated high retention rates, in that 87.50% of those enrolled in the program completed at least 6 out of the 8 sessions. Although there were no differences overall for sexual risk behaviors or depressive symptoms, among women with PTSD, significant reductions in depressive symptoms were observed in treatment compared to control, with an effect size of.84. Suicidal ideation and intent were reduced in both the treatment and control groups, with no attempts during the trial. AWARE is uniquely tailored to serve a pressing clinical need. These results support its feasibility and safety. A large-scale trial targeted at women with PTSD is recommended to further explore the efficacy of AWARE.