CompletedNot Applicable

Developing an Online Therapeutic Intervention for Chronic Pain in Veterans

United States42 participantsStarted 2022-03-17

Plain-language summary

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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

System Usability Scale (SUS)

Timeframe: Post-Intervention, at 8 weeks for VACT-CP group only

Usability Survey

Timeframe: Through study completion (pre and post), on average 8 weeks

Trial details

NCT IDNCT03655132

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2023-05-30

Results submitted2024-04-26

View on ClinicalTrials.gov More Chronic Pain trials