Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention - UG3 Pilot Study (RAMP-Pilot)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: RAMP program

Detailed Description

Pain is a complex biophysical, psychological, and social condition and there is a growing evidence base to support several complementary and integrative health (CIH) approaches, which can address pain in a more holistic way. While the VA has become a leader in advancing CIH through its Whole Health Initiative, there remain many barriers, especially for rural patients. This pilot study will assess the feasibility of an innovative telehealth evidence-based intervention for rural VA patients with chronic pain: the Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP). RAMP was developed with multiple-levels of VA stakeholders (including rural patients). It was designed to deliver multiple CIH self-management strategies (pain education, mindfulness, pain specific exercises, and cognitive behavioral strategies) in one intervention, to overcome existing barriers to care and improve rural Veterans' pain and important biopsychosocial outcomes.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VAMC

Participation Criteria

Eligibility Criteria

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: RAMP program; The RAMP program is a 12-week virtual program consisting of an individual session (50 minutes) with a Whole Health Coach followed by 11 weekly interactive group sessions (90 minutes each) with pre-recorded expert led education videos, mind-body skill training and practice, and facilitated discussions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Recruited	Number of participants recruited	3 months
Female Participants Recruited	Percentage of Female Participants Recruited	3 months
Racial/Ethnic Minoritized Participants Recruited	Percentage of Racial/Ethnic Minoritized Participants Recruited	3 months
Participant Satisfaction	Percentage of Participants Who Report Being "Somewhat Satisfied" or "Very Satisfied" with the Program on a 7-point Scale	3 months
Participant Engagement	Percentage of participants who participated in at least 7 out of 12 sessions either by attending the group session (i.e., synchronous participation) or reporting that they completed any of the session activities on their own (i.e., asynchronous participation)	3 months
Fidelity of Intervention Delivery	Two experts in developing and delivering mind-body interventions for pain independently observed 10% of sessions via videoconference using a structured checklist.	3 months
Survey Response Rate	Percentage of participants completing post-treatment data collection	3 month

Collaborators and Investigators

• Sponsor: Minneapolis Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Actual): March 24, 2025
• Study Completion (Actual): March 24, 2025

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; mindfulness; complementary therapies; models, biopsychosocial; rural Veterans health
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: 1UG3NR020929-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

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