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

M

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status

Completed

Conditions

Chronic Pain

Treatments

Behavioral: RAMP program

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT06568250
1UG3NR020929-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Intervention
Experimental group
Treatment:
Behavioral: RAMP program

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Lee Cross, MPH; Diana Burgess, PhD

Data sourced from clinicaltrials.gov

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