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

NCT06568250 | Completed Results DMC

• 1 other identifier: 1UG3NR020929-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Keywords

chronic pain; mindfulness; complementary therapies; models, biopsychosocial; rural Veterans health

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

Behavioral: RAMP program

Interventions

RAMP program BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead

Study Sites (1)

Minneapolis VAMC

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Diana Burgess, MPI
• Organization: Minneapolis VA Medical Healthcare System

diana.burgess@va.gov

612-467-1591

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Core Investigator

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 23, 2024
• Study Start: August 7, 2024
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: February 2, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-01

Locations

US (1)