Objectives: To test whether AWARE reduced depressive symptoms and sexual risk behaviors in participants over time. We also tested whether treatment effects would differ by the presence of a PTSD diagnosis at baseline.
Research Design: We employed a two-arm randomized clinical trial. Of 435 women who were initially screened, 63 women were eligible and randomized into either the intervention (n=32) or waitlist control (n=31) group (14.3% inclusion rate). AWARE consisted of 8 group sessions.
Measures: Retention rates, depressive symptoms, and sexual risk behaviors were assessed at baseline, post-intervention, and 3-month follow-up. The PCL-C (PTSD Checklist, Civilian version) was used to diagnose PTSD at baseline.
Results: 87.5% of randomized participants who started AWARE completed at least 6 of the 8 sessions. Compared to the control group, the intervention group did not experience reductions in depressive symptoms or sexual risk behaviors over time after controlling for baseline depressive symptoms. However, women with PTSD at baseline experienced significant reductions in depressive symptoms with an effect size of 0.84.
Conclusions: While AWARE did not demonstrate an overall effect on depressive symptoms or sexual risk behaviors, it is a highly feasible intervention that is efficacious in reducing depressive symptoms over time for those with PTSD. A full RCT is needed for future studies.