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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: RAMP Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diana Burgess, PhD; Phone Number: 612-467-1591; Email: diana.burgess@va.gov
• Study Contact Backup: Name: Lee Cross, MPH; Phone Number: 612-629-7568; Email: lee.cross@va.gov

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Recruiting
      • Minneapolis VAMC
      • Contact: Diana Burgess, PhD; Phone Number: 612-467-1591; Email: diana.burgess@va.gov
      • Contact: Lee Cross, MPH; Phone Number: 612-629-7568; Email: lee.cross@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: RAMP Program; 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.
No Intervention: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain interference	Measured using the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Measured using the Brief Pain Inventory (BPI) intensity score. Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
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.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
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.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
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.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Physical functioning	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.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Sleep disturbance	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.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Sleep duration	Participants self-report their hours of sleep per night in the past month.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Fatigue	The PROMIS fatigue 4-item short form v1.0, which measures fatigue over the past 7 days.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Participation in Social Roles and Activities	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.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Anxiety	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.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Depression	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.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Post Traumatic Stress Disorder (PTSD)	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.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Overall improvement	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.	Average over 6 months of follow-up, with assessments at 10 weeks and 6 months.
Percentage of participants self-reporting opioid medication use	Participant self report of opioid medication use.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Substance use	Measured using the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) survey. The TAPS is comprised of a 4-item screen for substance use.	Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Adverse events	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.	Average over 6 months of follow-up, with assessments at 10 weeks and 6 months.

Collaborators and Investigators

• Sponsor: Minneapolis Veterans Affairs Medical Center
• Investigators: Principal Investigator: Roni Evans, DC, PhD, MS, University of Minnesota; Principal Investigator: Katherine Hadlandsmyth, PhD, University of Iowa; Principal Investigator: Diana Burgess, PhD, Minneapolis Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; complementary therapies; Veteran; rural; models, biopsychosocial
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: 4UH3NR020929-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study data will be submitted to the National Institute of Mental Health (NIMH) Data Archive (NDA). Demographic and clinical outcome measures will be collected and shared using common data elements (CDEs ) from the NIH / HEAL CDE repository. Variable naming and permissible response values will be harmonized according to CDEs data dictionary specifications. Documentation to be made publicly available to the research community and will include: 1. The study protocol; 2. information sheet (provided per waiver of documentation of informed consent); 3. data collection forms/case report forms; 4. data dictionary.
• IPD Sharing Time Frame: Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared with the NDA repository no later than the end of the award.
• IPD Sharing Access Criteria: Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication. The research project team and PRISM/Collaboratory Program Coordinating Center will work together in order to offer deidentified or limited data sets that will be available to the public. Where practicable, Limited Datasets (LDSs) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or reidentifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. No PHI or VA sensitive data will be shared, unless approved by VA Privacy Officers. Only authorized research personnel as approved by the ACOS in agreement with the MPIs, will have access to individually identifiable data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No