Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 20, 2023
Date Accepted: Jan 29, 2023
An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol of a Randomized Pilot Feasibility Trial
ABSTRACT
Background:
In the veteran community, chronic pain is particularly prevalent and often debilitating. Until recently, veterans with chronic pain were offered primarily pharmacological intervention options, which rarely suffice and can also have negative health consequences. To better address chronic pain in veterans, the Veteran’s Health Administration (VHA) has invested in novel, non-pharmacological behavioral interventions that target both pain management and chronic pain-related functional issues. One approach, Acceptance and Commitment Therapy (ACT) for chronic pain, is supported by decades of efficacy evidence for improving pain outcomes, but can be difficult to obtain due to issues such as a lack of trained therapists or veterans having difficulty committing to the time and resources needed for the full clinician-led ACT protocol. Given the strong ACT evidence base combined with access limitations, we set out to develop and evaluate Veteran ACT for Chronic Pain (VACT-CP), an online program guided by an embodied conversational agent to improve pain management and functioning.
Objective:
The aims of this study are to develop, iteratively refine, and then conduct a pilot feasibility randomized controlled trial (RCT) of VACT-CP (n=20) versus a waitlist and treatment as-usual control group (WL+TAU: n=20).
Methods:
This research project includes three Phases. In Phase 1, our research team consulted with pain and virtual care experts, developed the preliminary VACT-CP online program, and conducted interviews with providers to obtain their feedback on the intervention. In Phase 2, we incorporated feedback from the prior Phase into the VACT-CP program and complete initial usability testing with veterans with chronic pain. In Phase 3, we are conducting a small pilot feasibility RCT, with the primary outcome to assess usability of the VACT-CP system.
Results:
This study is currently in Phase 3, and recruitment for the RCT began in April 2022 and is expected to continue through April 2023. Data collection is expected to be completed by October 2023, with full data analysis completed by late 2023.
Conclusions:
Findings from this research project will provide information on the usability of the VACT-CP intervention, as well as secondary outcomes related to treatment satisfaction, pain outcomes (pain-related daily functioning, and pain severity), ACT processes (pain acceptance, behavioral avoidance, and valued living), and mental and physical functioning. Clinical Trial: ClinicalTrials.gov NCT03655132; https://clinicaltrials.gov/ct2/show/ NCT03655132
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