RISE for PTSD and Substance Use Disorder in Veterans

Veterans with co-occurring posttraumatic stress disorder (PTSD) and substance use disorder (SUD) experience significant impairment and worse treatment outcomes compared to those with either condition alone, including higher rates of psychiatric hospitalization, relapse, and suicide risk. Unfortunately, integrated treatment options for PTSD-SUD remain extremely limited despite strong Veteran preference for integrated care over sequential or concurrent models. The only current integrated, evidence-based treatment aligned with VA/DoD clinical guidelines, Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE), requires 12 weekly 90-minute sessions and is associated with a 43-46% dropout rate, with most dropout occurring after six or more sessions. The high treatment burden and dropout rate indicate a critical need to develop a brief, effective, integrated intervention for Veterans with PTSD-SUD. Further, despite the chronic and relapsing nature of SUD, providers across SUD, PTSD, and general mental health clinics report a clear need for integrated treatments but continue to treat these conditions sequentially due to the siloed nature of specialty clinics.

Written Exposure Therapy (WET) is an evidence-based treatment for PTSD requiring only five 60-minute sessions, with substantially lower dropout than other trauma-focused therapies (6.4-12.5% versus 35.6-39.7% for Cognitive Processing Therapy and Prolonged Exposure) and demonstrated non-inferiority to both. The investigators have developed a treatment targeting PTSD and comorbid SUD called RISE (Rapid Recovery through Integrated Substance Use Treatment and Written Exposure for PTSD), that integrates WET with core components of Cognitive Behavioral Therapy for Substance Use Disorder (CBT-SUD), an evidence-based, VA-disseminated treatment that addresses the relationship between thoughts, emotions, behaviors, and environmental factors related to substance use. RISE incorporates functional analysis of substance use behaviors, skills for managing urges and cravings, cognitive restructuring, refusal skills, and relapse prevention and coping planning, delivered across six weekly, 90-minute individual sessions, half the treatment length of COPE.

The primary goal of the current study is to evaluate the feasibility and acceptability of RISE relative to CBT-SUD alone among Veterans with PTSD-SUD, using a randomized, two-arm pilot design. Thirty Veteran participants with PTSD-SUD will be randomized 2:1 to either 1) RISE, an integrated six-session treatment combining WET for PTSD with CBT-SUD skill components, or 2) CBT-SUD alone, delivered individually over a matched six-session, 90-minute format to equate total clinical contact time across arms. Both arms will be delivered in-person at the VA Mid-Atlantic MIRECC or via telehealth, per Veteran preference. Specific aims include: AIM 1) To evaluate the feasibility of RISE, including recruitment and enrollment rate, session attendance, and treatment completion rate, assessed continuously throughout the study's two-year enrollment period; AIM 2) To evaluate the acceptability of RISE using the Client Satisfaction Questionnaire-8, administered at post-treatment; and an EXPLORATORY AIM) To generate preliminary within-person estimates of change in PTSD symptom severity (PCL-5, CAPS-5) and substance use severity (BAM-R) at baseline, post-treatment, and 3-month follow-up, and to examine the proportion of Veterans no longer meeting diagnostic criteria for PTSD and/or a SUD (QuickSCID-5, CAPS-5) at post-treatment and follow-up, to inform effect size estimates for a future fully-powered non-inferiority trial. If RISE is found to be feasible and acceptable, it could be integrated into existing VA SUD, PTSD, and general mental health clinics without requiring the additional resources needed to implement COPE, meaningfully expanding Veterans' access to guideline-concordant, integrated PTSD-SUD care.