Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 27, 2024
Date Accepted: Jun 27, 2025
Assessment of Two Online Interventions for Veterans with Chronic Pain: Protocol for a Randomized Controlled Efficacy Trial
ABSTRACT
Background:
Chronic pain is a debilitating condition that disproportionately impacts U.S. veterans, who manage numerous negative pain-related outcomes. There is an urgent need for accessible, engaging, and innovative treatments that can help veterans with chronic pain better self-manage their pain at home and improve their life functioning. Technology-delivered acceptance- and mindfulness-based interventions for pain have shown strong efficacy, especially when they are engaging and tailored to specific client needs. However, more research is needed to assess the impact of such interventions, especially in terms of pain-related functioning and quality of life.
Objective:
The primary aim of this study is to test the efficacy of Veteran ACT for Chronic Pain (VACT-CP), an online self-management pain program, compared to an active online control (Online Pain School) for improving pain-related functioning in a three-site randomized controlled trial. The secondary aim is to explore psychological flexibility as a potential mediator between pain severity and pain-related functioning.
Methods:
This study will use mixed-methods to examine the efficacy of VACT-CP in a 2-arm multisite, randomized controlled superiority trial of 200 participants with chronic musculoskeletal pain, with VACT-CP compared to Online Pain School. Participants will be assigned to either online intervention, both of which will include 7 modules over 7 weeks for approximately 15 minutes each. Mixed-Effects Models will be used to analyze the primary hypothesis that participants in the VACT-CP group will have greater improvement in pain-related functioning (BPI-Interference) than those in the active control group (Online Pain School). The main Acceptance and Commitment Therapy (ACT) process mediator (i.e., Multidimensional Psychological Flexibility Inventory [MPFI]), pain-related functioning outcomes (BPI-Interference), and quality of life (VR-36) will be measured at baseline, end of treatment, 3-months, and 6-months post-treatment. Additionally, qualitative exit interviews will be conducted with a random set of 30 VACT-CP users (10 per site) to obtain intervention usability, feasibility, and acceptability information.
Results:
This study is scheduled to begin recruitment in January 2025. Recruitment is expected to continue through January 2027, data collection expected to be completed by June 2027, and primary data analyses expected to be completed by early 2028.
Conclusions:
Online interventions like VACT-CP have the potential to expand access to behavioral interventions (i.e., ACT) that improve quality of life and provide non-pharmacological pain treatment options for veterans experiencing chronic pain. However, research on their impact and underlying mechanisms of change is required to support this area of potential at-home support. Clinical Trial: ClinicalTrials.gov ID NCT06058624
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