Developing an Online Therapeutic Intervention for Chronic Pain in Veterans

Completed · Not applicable

Conditions studied: Chronic Pain

In brief

Chronic pain is a serious concern that disproportionately affects Veterans compared to the general public; Veterans are diagnosed with chronic pain at particularly high rates (47 - 56%) with a 40% greater rate of severe pain than non-Veterans. Veterans with chronic pain face numerous negative functional outcomes, including decreased ability to complete daily work activities, less social support from and closeness with family members, increased chronic health conditions (e.g., cancer, heart disease), and higher mortality compared to Veterans without chronic pain. Given these concerns, there is an urgent need for innovative and integrative approaches for non-medical pain self-management management. Despite the critical importance of effective pain self-management programs, many Veterans with chronic pain do not engage in pain self-management programs. In order to improve Veterans' quality of life, it is important to develop and evaluate innovative, accessible, evidence-based interventions for managing chronic pain. One approach with over twenty years of efficacious treatment for chronic pain is Acceptance and Commitment Therapy (ACT) for Chronic Pain (ACT-CP). ACT is a well-established VA-approved approach to chronic pain management, and focuses on committing to behavior change that reflects personal values, leading to significant improvement in life functioning. ACT- CP is associated with substantial improvements in social/work functioning and decreased pain-related medical visits, as long as three years following treatment. For adults with chronic pain, technology-assisted ACT treatment leads to reduced self-reported pain levels and improved health via changes in value-aligned behaviors and mindfulness. The use of interactive technology-assisted ACT treatment is acceptable and efficacious; however, no ACT for chronic pain online treatment exists for Veterans. The investigators will thus complete a three-phase development, intervention usability and feasibility, and randomized controlled trial (RCT) pilot to create Veteran ACT intervention for chronic pain (VACT-CP). VACT-CP will utilize a personalized, social interface to address pain-related distress and functional difficulties of chronic pain (e.g., avoidance, reactivity), using an online Embodied Conversational Agent (ECA) that will walk Veterans through eight weeks of treatment. Studies suggest that the use of such ECAs can increase online-treatment motivation and feedback, resulting in increased treatment compliance and utilization, physical functioning (e.g., increased physical activity and diet fidelity), and client-goal achievement. The primary outcomes for this project will be to (1) develop the VACT-CP user system using feedback from mental health and other clinical professionals treating chronic pain (n = 10), (2) pilot the usability and feasibility of the through iterative usability development and Veteran feedback (n = 12 - 15), and (3) explore the impact of the VACT-CP system in terms of user-experience, functional outcome improvement, and quality of life measures (n = 40).

Key facts

Study ID: NCT03655132
Run by: VA Office of Research and Development
People needed: 42
Starts: 2022-03-17
Expected to finish: 2023-10-31
Last updated by the study team: 2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Current diagnosis of non-cancer chronic pain, defined as:
at least one pain-related diagnosis indicated by an ICD-9 or -10 code related to either Musculoskeletal pain or Joint Problems/Osteoarthritis
or presence of chronic pain of at least mild to moderate severity as indicated by two or more NRS pain scores of 4 at three separate VA outpatient visits in past year based on a CPRS record review;
Has a working, high-speed wireless internet connection at home, or is willing to access sessions either at the Bedford VAMC by using a tablet in a secure space
Competent to provide written informed consent

You may not qualify if…

Any current or lifetime DSM-5 psychotic disorder
Current or recent (within 1 month of study entry) DSM-5 alcohol or drug use disorder
[Current use of any other chronic pain-related behavioral or psychological treatment]
Any cognitive impairment that would interfere with study participation
Clinically significant suicidality within the past year
Presence of any clinical features requiring a higher level of care (inpatient or partial hospital treatment)
Any cognitive or physical impairment that would interfere with study participation of using a tablet/computer and providing feedback

Where it is running

VA Bedford HealthCare System, Bedford, MA — Bedford, Massachusetts, United States

Full record on ClinicalTrials.gov

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