Project STRONGER Evaluating a Stepped Care Behavioral Therapy to Improve Retention in Opioid Use Disorder Treatment for Women with PTSD and Intimate Partner Violence Experience

What this Trial Is About

Researchers are evaluating a novel stepped care model called PCT2HOPE compared to treatment as usual TAU to improve retention in medication for opioid use disorder MOUD among women who have experienced intimate partner violence IPV. This study focuses on women with opioid use disorder OUD who also have PTSD-related impairment, aiming to assess the impact on retention in treatment, trauma symptoms, substance use, depression, recovery, and empowerment. The study uses a hybrid effectiveness-implementation approach to understand how well PCT2HOPE works and how it can be applied in community settings. Participants receive PCT through eight weekly 1-hour group sessions over 12 weeks, facilitated by trained counselors at their MOUD treatment program. Women who are not retained in MOUD or have moderate or higher PTSD-related impairment after 12 weeks are stepped up to HOPE, which offers 10 individual 1-hour counseling sessions over the following 14 weeks. HOPE focuses on empowerment, cognitive behavioral skills, and healthy relationships without processing traumatic memories. Participants also receive community resource lists and referrals to domestic violence services. During the study, participants are assessed for retention in MOUD treatment at 26 weeks, along with measures of PTSD impairment, opioid use, depression, recovery, and empowerment. Researchers track substance use through urine tests and questionnaires. The trial is randomized without masking and involves women aged 18 and older currently receiving MOUD. The study runs from June 2026 to August 2029, with evaluations occurring primarily at 26 weeks after starting the intervention.

Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery