Leveraging VA National Data, Expert Consensus, and Veteran Input to Develop and Refine a Pragmatic Trial Protocol Comparing Integrated Interventions to Address Co-Occurring Pain and PTSD in Veterans

Background: Chronic pain and posttraumatic stress disorder (PTSD) are prevalent co-occurring conditions in Veterans associated with poorer health and functioning. These conditions are challenging to treat, especially when Veterans are prescribed opioids. Typically, each condition is treated separately, either sequentially, creating delays, or in parallel with little coordination between providers resulting in each condition negatively impacting the outcomes of the other. Based on theoretical models, observational evidence, and pilot trials, we hypothesize that integrated treatments that simultaneously address chronic pain, PTSD, and opioid dependence may be a feasible and acceptable approach for Veterans with all three conditions. Significance: National VA/DoD clinical practice guidelines lack information on best practices for managing comorbid pain, PTSD, and problematic opioid use in VA patients. This represents a key health services gap leaving large numbers of Veterans at risk for serious adverse outcomes. Innovation & Impact: With input of subject matter experts (SMEs), Veterans with lived experience, and clinical data from the VA electronic health record (EHR), we propose to iteratively design a pragmatic implementation- effectiveness trial comparing two interdisciplinary integrated therapies for the simultaneous treatment of co- occurring chronic pain and PTSD in Veterans prescribed opioids. This study has the potential for high impact as the current dominant treatments address each condition sequentially or in parallel and hence risk poor treatment outcomes and no trials for these co-occurring conditions have included patients prescribed opioids. High quality pragmatic trials designed as implementation-effectiveness studies conducted by VA clinicians in real-world VA clinical settings are urgently needed to generate actionable evidence to support clinical guidelines for the care of this high-risk population. Specific Aims: Aim 1: Convene SMEs (clinicians, researchers, and VA operational partners) who will assist the research team in developing a pragmatic implementation-effectiveness trial protocol to compare two integrated interdisciplinary approaches (including a medical prescriber) for the simultaneous treatment of Veterans with co-occurring chronic pain and PTSD prescribed opioids. Aim 2: Convene Veterans with lived experience to review components of the draft protocol to ensure inclusivity, acceptability, and feasibility. Methodology: For Aim 1, through individual interviews and group meetings, SMEs will use extant published, unpublished, VA EHR data (generated as part of this study), and their own experience to provide input in iteratively developing and refining a pragmatic implementation-effectiveness trial protocol to compare a more traditional trauma-informed CBT-based intervention to a trauma-informed complementary and integrative health intervention for Veterans with co-occurring chronic pain and PTSD who may be prescribed opioids. For Aim 2, we will convene a Veteran engagement panel (VEP) including a diverse and inclusive group of Veterans with lived experience of pain, PTSD, and prescription opioid use. The VEP will provide feedback on the draft trial protocol to ensure trial interventions and components will be acceptable and feasible for Veterans and responsive to their needs and preferences for care. Incorporating SME and VEP input from Aims 1 and 2, the research team will finalize the trial protocol, forming the basis of a subsequent MERIT Review proposal. Next Steps/Implementation: This study will result in the first-ever multi-site pragmatic implementation- effectiveness clinical trial protocol to comparing two integrated interdisciplinary interventions for the care of Veterans with co-occurring chronic pain and PTSD prescribed opioids. We have included VA operations partners (e.g., Office of Pain Management, National Center for PTSD, Office of Patient-Centered Care) as study stakeholders. Operatio Project Number: 1I21HX003886-01A1 | Fiscal Year: 2025 | NIH Institute/Center: Veterans Affairs (VA) | Principal Investigator: Karen Seal | Institution: VETERANS AFFAIRS MED CTR SAN FRANCISCO, SAN FRANCISCO, CA | Activity Code: I21 | Study Section: HSR-4 Mental and Behavioral Health[HSR4] View on NIH RePORTER: https://reporter.nih.gov/project-details/10994495