Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial.

BACKGROUND: Chronic pain and opioid use disorder (OUD) individually represent a risk to health and well-being. Concerningly, there is evidence that they are frequently co-morbid. While few treatments exist that simultaneously target both conditions, preliminary work has supported the feasibility of an integrated behavioral treatment targeting pain interference and opioid misuse. This treatment combined Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (ACT+MBRP). This paper describes the protocol for the adequately powered efficacy study of this integrated treatment. METHODS: A multisite randomized controlled trial will examine the efficacy of ACT+MBRP in comparison to a parallel education control condition, focusing on opioid safety and pain education. Participants include veterans (n = 160; 21-75 years old) recruited from three Veterans Administration (VA) Healthcare Systems with chronic pain who are on a stable dose of buprenorphine. Both conditions include twelve weekly 90 min group sessions delivered via telehealth. Primary outcomes include pain interference (Patient Reported Outcome Measurement Information System - Pain Interference) and hazardous opioid use (Current Opioid Misuse Measure), which will be examined at the end of the active treatment phase and through 12 months post-intervention. Secondary analyses will evaluate outcomes including pain intensity, depression, pain-related fear, and substance use, as well as treatment mechanisms. CONCLUSION: This study will determine the efficacy of an integrated behavioral treatment program for pain interference and hazardous opioid use among veterans with chronic pain and OUD who are prescribed buprenorphine, addressing a critical need for more integrated treatments for chronic pain and OUD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04648228.

Testing a tailored weight management program for veterans with PTSD: The MOVE! + UP randomized controlled trial.

Post-traumatic stress disorder (PTSD), prevalent among Veterans, increases risk for having a high Body Mass Index. Although the Veterans Health Administration (VHA) offers an evidence-based behavioral weight management program called MOVE!, participants with PTSD lose less weight than those without mental health conditions, despite comparable participation. PTSD symptoms can interfere with one's ability to be physically active and maintain a healthy diet, the key targets in weight management programs. We developed and piloted a behavioral weight management program called MOVE! + UP that targets PTSD-related weight loss barriers. MOVE! + UP includes 16 group sessions with training in evidence-based weight management strategies, coupled with Cognitive Behavior Therapy (CBT) skills to address PTSD-specific barriers. The 16 sessions also include 30-min community walks to address PTSD-related barriers that may impede exercise. Two individual dietician sessions are provided. This hybrid type 1 randomized controlled trial (RCT) will compare MOVE! + UP to standard care-MOVE!-among 164 Veterans with BMI ≥ 25 who are receiving care for PTSD. We will randomize participants to MOVE! + UP or standard care and will compare absolute post-baseline change in weight at 6 (primary outcome) and 12 (secondary outcome) months, and PTSD symptom severity at 6 and 12 months (secondary outcome). Exploratory analyses will compare the treatment conditions on treatment targets measured at 6 months (e.g., physical activity, eating behavior, social support). Finally, we will estimate intervention costs, and identify MOVE! + UP implementation barriers and facilitators. If effective, MOVE! + UP could be an efficient way to simultaneously address physical and mental health for Veterans with PTSD.