Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention - UH3
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RAMP Program.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention
Overview
The goal of the RAMP mind-body program is to provide Veterans with information and tools that can help them manage their pain. The program explores the important connection between our bodies and minds, and how to use this special connection to manage pain more effectively.
Detailed description
Our long-term objective is to improve pain management and reduce opioid use among rural patients in the VA. To accomplish this, we will conduct a randomized clinical trial (RCT) to test the effectiveness of an innovative multi-component complementary and integrative intervention, Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP) delivered via group telehealth, for improving rural Veterans' pain management, function, and wellbeing, within the VA healthcare system. This project addresses the significant challenge of implementing effective, non-opioid interventions for chronic pain management among rural Veterans, who experience a disproportionate share of the national pain burden, with more chronicity, opioid harms, comorbid mental health conditions and substance abuse, and are prescribed more opioids and have less access to evidence-based, chronic pain care that addresses their "whole-person" or biopsychosocial needs. The RAMP program strategically coalesces multiple evidence based CIH self-management strategies to address rural Veterans' biopsychosocial needs and overcome existing barriers to implementation. Comprised of pain education, mindfulness, pain specific exercises, and cognitive behavioral strategies, the program is cohesive and scalable.
Interventions
- Behavioral RAMP Program
RAMP is a 9-week program comprised of weekly online group sessions (90 minutes each) with pre-recorded expert-led education videos, mind-body skill training and practice, and facilitated discussions.
Primary outcome measures
- Pain interference [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
Secondary outcome measures (12)
- Pain intensity [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Pain impact [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Quality of life [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Quality of life [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Physical functioning [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Sleep disturbance [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Sleep duration [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Fatigue [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Participation in Social Roles and Activities [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Anxiety [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Depression [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Post Traumatic Stress Disorder (PTSD) [Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
Eligibility criteria
Inclusion criteria
- 18 years of age or older
- rural-dwelling based on U.S. Health Services Research Administration Criteria
- chronic pain based on two qualifying pain diagnoses in their electronic health record (EHR) within the same diagnostic category, at least 90 days apart, during the previous 2 years
- self-reported pain on at least most days in the past 3 months
- Brief Pain Inventory Interference subscale score ≥ 4/10
- access to a device with internet
- willingness to engage in intervention-specific procedures (e.g., meet remotely online for sessions)
- an email address listed in the EHR.
Exclusion criteria
- severe, poorly controlled psychiatric or substance use disorder (identified by chart review)
- active member of advisory panel for the study
- enrollment in another research study for pain
- enrollment in a similar study
- enrollment in a similar facilitated, multi-week, multi-modal complementary and integrative health program.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Minneapolis VAMC — Minneapolis
Identifiers
NCT: NCT07541599 · 4UH3NR020929-02