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

NCT06568250 — Not applicable, Completed, 40 participants, Minneapolis Veterans Affairs Medical Center

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

RegistryNCT06568250, acronym RAMP-Pilot
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment40 (Actual)
SponsorMinneapolis Veterans Affairs Medical Center (Fed)
ConditionsChronic Pain
InterventionsRAMP program (Behavioral)
Datesstart 2024-08-07, primary completion 2025-03-24, completion 2025-03-24, first posted 2024-08-23, last updated 2026-02-02
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Pain All trials of RAMP program

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
InterventionExperimentalBehavioral: RAMP program
  • 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.

+Outcome measures

Primary outcomes

  • Participants Recruited [3 months]: Number of participants recruited
  • Female Participants Recruited [3 months]: Percentage of Female Participants Recruited
  • Racial/Ethnic Minoritized Participants Recruited [3 months]: Percentage of Racial/Ethnic Minoritized Participants Recruited
  • Participant Satisfaction [3 months]: Percentage of Participants Who Report Being "Somewhat Satisfied" or "Very Satisfied" with the Program on a 7-point Scale
  • Participant Engagement [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 [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 [3 month]: Percentage of participants completing post-treatment data collection

+Eligibility

Sex: All, ages: 18 Years to any

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)

+Posted results

Participant flow

MilestoneIntervention
Started40
Completed27
Not completed13

Outcome results

  • Participants Recruited (Primary), Count of participants, Participants: Intervention 40
  • Female Participants Recruited (Primary), Count of participants, Participants: Intervention 21
  • Racial/Ethnic Minoritized Participants Recruited (Primary), Count of participants, Participants: Intervention 22
  • Participant Satisfaction (Primary), Count of participants, Participants: Intervention 26
  • Participant Engagement (Primary), Count of participants, Participants: Intervention 27
  • Fidelity of Intervention Delivery (Primary), Count of units, sessions: Intervention 6
  • Survey Response Rate (Primary), Count of participants, Participants: Intervention 30

Adverse events

Time frame: From consent until 30 days after the last day of study participation (5 months on average).

ArmDeathsSerious adverse eventsOther adverse events
Intervention0/40 (0.0%)0/40 (0.0%)0/40 (0.0%)

+Locations (1)

FacilityCityCountryStatus
Minneapolis VAMCMinneapolis, MinnesotaUnited States

+Study documents