Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention - UH3

ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinneapolis Veterans Affairs Medical Center

About this trial

The goal of the RAMP mind-body program is to provide Veterans with information and tools that can help them manage their pain. The program explores the important connection between our bodies and minds, and how to use this special connection to manage pain more effectively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

rural-dwelling based on U.S. Health Services Research Administration Criteria

chronic pain based on two qualifying pain diagnoses in their electronic health record (EHR) within the same diagnostic category, at least 90 days apart, during the previous 2 years

self-reported pain on at least most days in the past 3 months

Disqualifiers

severe, poorly controlled psychiatric or substance use disorder (identified by chart review)

active member of advisory panel for the study

enrollment in another research study for pain

enrollment in a similar study

Trial design

Design model

Parallel

Treatments tested in this trial

  • RAMP Program

    Behavioral

    RAMP is a 9-week program comprised of weekly online group sessions (90 minutes each) with pre-recorded expert-led education videos, mind-body skill training and practice, and facilitated discussions.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Pain interference

Measured using the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning.

Time frame
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.

Secondary outcomes

1

Pain intensity

Measured using the Brief Pain Inventory (BPI) intensity score. Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain.

Time frame
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
2

Pain impact

Measured using the Graded Chronic Pain Scale-Revised (GCPS-R), a six item scale developed to differentiate mild, bothersome, and high-impact chronic pain. Two questions to identify chronic pain and high impact chronic pain; frequency of pain during the prior 3 months and frequency of limitation in activities in the prior 3 months.

Time frame
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
3

Quality of life

Measured using the World Health Organization (WHO) 2-item measure which measures quality of life and satisfaction with health on a 1 to 5 scale.

Time frame
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
4

Quality of life

Measured using the Euro Quality of Life scale, a 5 section questionnaire to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Time frame
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.

Other outcomes

Sponsors and contacts

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