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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
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.
Minneapolis VAMC
Minneapolis, Minnesota, United States
RECRUITINGPain interference
Measured using the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Pain intensity
Measured using the Brief Pain Inventory (BPI) intensity score. Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Pain impact
Measured using the Graded Chronic Pain Scale-Revised (GCPS-R), a six item scale developed to differentiate mild, bothersome, and high-impact chronic pain. Two questions to identify chronic pain and high impact chronic pain; frequency of pain during the prior 3 months and frequency of limitation in activities in the prior 3 months.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Quality of life
Measured using the World Health Organization (WHO) 2-item measure which measures quality of life and satisfaction with health on a 1 to 5 scale.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Quality of life
Measured using the Euro Quality of Life scale, a 5 section questionnaire to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Physical functioning
Using the PROMIS Physical functioning 6-item short form v2.0 which measures difficulty doing household activities and agreement with statements on health limitations in physical activities on a 1 to 5 scale.
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Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Sleep disturbance
Measured using PROMIS 6-item short form v1.0 which measures sleep quality on a 1 to 5 scale from very poor to very good in addition to agreement with statements on sleep quality on a 1 to 5 scale.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Sleep duration
Participants self-report their hours of sleep per night in the past month.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Fatigue
The PROMIS fatigue 4-item short form v1.0, which measures fatigue over the past 7 days.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Participation in Social Roles and Activities
Measured using the PROMIS 4-item short form v2.0 which measures frequency of trouble doing activities for leisure, work, or with family or friends on a 1 to 5 scale.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Anxiety
Anxiety will be measured using the Generalized Anxiety Disorder-2 survey (GAD-2) which includes 2 questions that are summed for a total score that can range from 0 to 6.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Depression
Depression will be measured using the Patient Health Questionnaire-2 (PHQ-2) which includes 2 questions that are summed for a total score that can range from 0 to 6.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Post Traumatic Stress Disorder (PTSD)
Measured using the Primary Care PTSD Screen for DSM-5, which asks whether the participant has had exposure to a traumatic event, and if yes, asks 5 follow-up yes/no question regarding experiences in the past month.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Overall improvement
Overall improvement will be assessed with the Patient Global Impression of Change (PGIC) which has participants rate their overall change from very much worse to very much improved on a 7-point scale.
Time frame: Average over 6 months of follow-up, with assessments at 10 weeks and 6 months.
Percentage of participants self-reporting opioid medication use
Participant self report of opioid medication use.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Substance use
Measured using the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) survey. The TAPS is comprised of a 4-item screen for substance use.
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Adverse events
Participant self-report of any new or worsening health issue while participating in the study. Participants will also be asked to report potential side effects by choosing from a list of known potential risks of exercise and mindfulness interventions.
Time frame: Average over 6 months of follow-up, with assessments at 10 weeks and 6 months.