Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Inter… (NCT06568250) | Clinical Trial Compass
CompletedNot Applicable
Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention - UG3 Pilot Study
United States40 participantsStarted 2024-08-07
Plain-language summary
This project addresses the significant challenge of providing evidence-based non-pharmacologic pain management to rural-dwelling Veterans in the VA healthcare system who have chronic pain. For this preparatory phase (UG3), the investigators will conduct a single-arm pilot study of 40 rural VA patients with chronic pain to assess study feasibility (recruitment and retention), intervention feasibility (fidelity of intervention delivery and participant engagement rates), acceptability, and effectiveness at addressing pre-defined capabilities, opportunities and motivations.
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:
* Veteran participants must be rural dwelling
* Patient's Veterans Affairs (VA) primary care provider is in the Southeast region of the US
* Email address in the VA electronic health record (EHR)
* Report pain at least most days in the past 3 months
* Brief Pain Inventory (BPI) Pain Interference subscale score of 4 or greater
* Willingness and ability to complete study activities including meeting remotely via videoconferencing when program sessions are held
Exclusion Criteria:
* Participation in a prior project conducted by the study team on mindfulness for pain (NCT0456158) or an engagement activities advisor for the current project
* Current enrollment in a research study for pain
* Current enrollment in a similar facilitated, multi-week, multi-modal CIH program
* Severe, poorly controlled psychiatric or substance use disorder (based on chart review using structured checklists, conducted by trained staff who are trained and supervised by a clinical psychologist)
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
1
Participants Recruited
Timeframe: 3 months
2
Female Participants Recruited
Timeframe: 3 months
3
Racial/Ethnic Minoritized Participants Recruited
Timeframe: 3 months
4
Participant Satisfaction
Timeframe: 3 months
5
Participant Engagement
Timeframe: 3 months
6
Fidelity of Intervention Delivery
Timeframe: 3 months
7
Survey Response Rate
Timeframe: 3 month
Trial details
NCT IDNCT06568250
SponsorMinneapolis Veterans Affairs Medical Center