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Clinical Trials/NCT06568250
NCT06568250
Completed
Not Applicable

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

Minneapolis Veterans Affairs Medical Center1 site in 1 country40 target enrollmentAugust 7, 2024
ConditionsChronic Pain
InterventionsRAMP program

Overview

Phase
Not Applicable
Intervention
RAMP program
Conditions
Chronic Pain
Sponsor
Minneapolis Veterans Affairs Medical Center
Enrollment
40
Locations
1
Primary Endpoint
Participants Recruited
Status
Completed
Last Updated
2 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 7, 2024
End Date
March 24, 2025
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Minneapolis Veterans Affairs Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Diana J. Burgess

Core Investigator

Minneapolis Veterans Affairs Medical Center

Eligibility Criteria

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)

Arms & Interventions

Intervention

Intervention: RAMP program

Outcomes

Primary Outcomes

Participants Recruited

Time Frame: 3 months

Number of participants recruited

Female Participants Recruited

Time Frame: 3 months

Percentage of Female Participants Recruited

Racial/Ethnic Minoritized Participants Recruited

Time Frame: 3 months

Percentage of Racial/Ethnic Minoritized Participants Recruited

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

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)

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.

Survey Response Rate

Time Frame: 3 month

Percentage of participants completing post-treatment data collection

Study Sites (1)

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