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NCT Number: NCT07541599

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Our long-term objective is to improve pain management and reduce opioid use among rural patients in the VA. To accomplish this, we will conduct a randomized clinical trial (RCT) to test the effectiveness of an innovative multi-component complementary and integrative intervention, Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP) delivered via group telehealth, for improving rural Veterans' pain management, function, and wellbeing, within the VA healthcare system. This project addresses the significant challenge of implementing effective, non-opioid interventions for chronic pain management among rural Veterans, who experience a disproportionate share of the national pain burden, with more chronicity, opioid harms, comorbid mental health conditions and substance abuse, and are prescribed more opioids and have less access to evidence-based, chronic pain care that addresses their "whole-person" or biopsychosocial needs. The RAMP program strategically coalesces multiple evidence based CIH self-management strategies to address rural Veterans' biopsychosocial needs and overcome existing barriers to implementation. Comprised of pain education, mindfulness, pain specific exercises, and cognitive behavioral strategies, the program is cohesive and scalable.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Brief Pain Inventory Interference subscale score ≥ 4/10
  • access to a device with internet
  • willingness to engage in intervention-specific procedures (e.g., meet remotely online for sessions)
  • an email address listed in the EHR.

Exclusion criteria

  • 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
  • enrollment in a similar facilitated, multi-week, multi-modal complementary and integrative health program.

Treatment and study plan

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.

Primary outcomes

  1. Pain interference

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

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

Secondary outcomes

  1. Pain intensity

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

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

  2. Pain impact

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

    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.

  3. Quality of life

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

    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.

  4. Quality of life

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

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

  5. Physical functioning

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

    Using the PROMIS Physical functioning 6-item short form v2.0 which measures difficulty doing household activities and agreement with statements on health limitations in physical activities on a 1 to 5 scale.

  6. Sleep disturbance

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

    Measured using PROMIS 6-item short form v1.0 which measures sleep quality on a 1 to 5 scale from very poor to very good in addition to agreement with statements on sleep quality on a 1 to 5 scale.

  7. Sleep duration

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

    Participants self-report their hours of sleep per night in the past month.

  8. Fatigue

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

    The PROMIS fatigue 4-item short form v1.0, which measures fatigue over the past 7 days.

  9. Participation in Social Roles and Activities

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

    Measured using the PROMIS 4-item short form v2.0 which measures frequency of trouble doing activities for leisure, work, or with family or friends on a 1 to 5 scale.

  10. Anxiety

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

    Anxiety will be measured using the Generalized Anxiety Disorder-2 survey (GAD-2) which includes 2 questions that are summed for a total score that can range from 0 to 6.

  11. Depression

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

    Depression will be measured using the Patient Health Questionnaire-2 (PHQ-2) which includes 2 questions that are summed for a total score that can range from 0 to 6.

  12. Post Traumatic Stress Disorder (PTSD)

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

    Measured using the Primary Care PTSD Screen for DSM-5, which asks whether the participant has had exposure to a traumatic event, and if yes, asks 5 follow-up yes/no question regarding experiences in the past month.

  13. Overall improvement

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

    Overall improvement will be assessed with the Patient Global Impression of Change (PGIC) which has participants rate their overall change from very much worse to very much improved on a 7-point scale.

  14. Percentage of participants self-reporting opioid medication use

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

    Participant self report of opioid medication use.

  15. Substance use

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

    Measured using the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) survey. The TAPS is comprised of a 4-item screen for substance use.

  16. Adverse events

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

    Participant self-report of any new or worsening health issue while participating in the study. Participants will also be asked to report potential side effects by choosing from a list of known potential risks of exercise and mindfulness interventions.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Burgess, PhD

CONTACT

[email protected]

612-467-1591

Lee Cross, MPH

CONTACT

[email protected]

612-629-7568

Sponsors and collaborators

Lead sponsor

Minneapolis Veterans Affairs Medical Center

Fed

Registry information

Official study title

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

Acronym: RAMP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 21, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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