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Completed

NCT Number: NCT06568250

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

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.

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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

Minneapolis VAMC

Minneapolis, Minnesota, 55417, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

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.

Primary outcomes

  1. Participants Recruited

    Time frame: 3 months

    Number of participants recruited

  2. Female Participants Recruited

    Time frame: 3 months

    Percentage of Female Participants Recruited

  3. Racial/Ethnic Minoritized Participants Recruited

    Time frame: 3 months

    Percentage of Racial/Ethnic Minoritized Participants Recruited

  4. Participant Satisfaction

    Time frame: 3 months

    Percentage of Participants Who Report Being "Somewhat Satisfied" or "Very Satisfied" with the Program on a 7-point Scale

  5. Participant Engagement

    Time frame: 3 months

    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)

  6. Fidelity of Intervention Delivery

    Time frame: 3 months

    Two experts in developing and delivering mind-body interventions for pain independently observed 10% of sessions via videoconference using a structured checklist.

  7. Survey Response Rate

    Time frame: 3 month

    Percentage of participants completing post-treatment data collection

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-Pilot

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2024
Registry last updated
Feb 2, 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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