Assessing the Efficacy of an Acceptance-Based Digital Intervention for Veterans With Chronic Pain
Part of paid clinical trials in West Haven, Connecticut.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT06058624
- Status
- Recruiting
Conditions
- Chronic Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Veteran ACT for Chronic Pain (VACT-CP) — BEHAVIORALParticipants receive 7 online modules, provided as weekly sessions that feature Coach Anne as a virtual, animated treatment guide. All content is presented interactively, through text-based conversations with Coach Anne. Veterans will hear what Coach Anne "says" and respond to her using text-based dialogue options that will trigger different responses from Coach Anne as the conversation progresses, to allow the system to responsively interact in a personalized manner with the Veteran. Veterans will also be presented with videos (e.g., Veteran narratives, metaphors), in-module assessments (e.g., values assessments), and interactive opportunities for goal setting.
- Online Pain School — BEHAVIORALParticipants will receive 7 modules (15 to 20 minutes each) of content based on a common non-ACT based VA treatment option, Pain School. The adaptation used for this study, "Online Pain School", will support Veterans' self-management of their chronic pain by providing informational videos on chronic pain and its health impacts, short behavioral exercises to help with pain management, and psychoeducation on different wellness techniques for their "pain management toolbox."
Study Details
Pain has been identified as among the most frequent presenting medical complaints, in particular within primary care for Veterans. There are few areas of daily living and functioning that pain intensity does not impact, with reported pain intensity related to difficulties in social situations and changes in activities of daily life, sleep, and appetite. Therapeutic interventions such as Acceptance and Commitment Therapy for Chronic Pain (ACT-CP) that target issues related to the cognitions and emotional concerns related to chronic pain have been well-documented for reduction of associated psychiatric symptoms and modest pain relief. At the same time, online programming can improve the ability of pain psychoeducation programs and ACT-CP to reach patients. The proposed project will compare online Veteran ACT for Chronic Pain (VACT-CP) compared to another pain program, Online Pain School, to evaluate how they assist Veterans with chronic pain to improve their functioning, pain management, and quality of life.
Key Dates
- Start date
- Jul 31, 2024
- Status verified
- Jul 2025
- Primary completion
- May 1, 2027
- Completion
- Oct 31, 2027
Study Design
- Enrollment
- 240 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Veteran ACT for Chronic Pain (VACT-CP)Participants will complete seven modules (each approximately 15 minutes) over seven weeks. The purpose of VACT-CP is to assist with at home therapeutic and behavioral self-management of chronic pain, based on the principles of acceptance and commitment therapy. Following the end of treatment (7 weeks), participants will complete post-treatment surveys at Week 7, Month 3, and Month 6 to provide feedback and information regarding 1) the intervention and 2) the potential impact of the intervention on functioning, quality of life, and other mental and physical health factors.
- Active Comparator: Online Pain SchoolParticipants will complete seven modules (each approximately 15 minutes) over seven weeks. Online Pain School is designed to balance for time participating in the intervention, and is also an active online attention control. The goal of this program will be to provide Veterans with more tools and options for pain management, and the online format will allow us to monitor website use/dose. Following the end of treatment (7 weeks), participants will complete post-treatment surveys at Week 7, Month 3, and Month 6 to provide feedback and information regarding 1) the intervention and 2) the potential impact of the intervention on functioning, quality of life, and other mental and physical health factors.
Primary Outcome Measure
Brief Pain Inventory Change [ Time Frame: Week 7, 3-Month Follow-Up, 6 Month Follow-Up ]
Central Contacts
- Erin D Reilly, PhD(781) 687-4191
- Caitlin M Girouard, MA BA(781) 687-4192
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516-2770 | |
| VA Bedford HealthCare System, Bedford, MA | Bedford | Massachusetts | 01730-1114 | Erin D. Reilly, PhD (PRINCIPAL_INVESTIGATOR) |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas | 75216-7167 |
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