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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAMP Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain interference | Measured using the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning. | Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Measured using the Brief Pain Inventory (BPI) intensity score. Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain. | Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months. |
| Pain impact |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Burgess, PhD | Contact | 612-467-1591 | diana.burgess@va.gov | |
| Lee Cross, MPH | Contact | 612-629-7568 | lee.cross@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Roni Evans, DC, PhD, MS | University of Minnesota | Principal Investigator |
| Katherine Hadlandsmyth, PhD | University of Iowa | Principal Investigator |
| Diana Burgess, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VAMC | Recruiting | Minneapolis | Minnesota | 55417 | United States |
The study data will be submitted to the National Institute of Mental Health (NIMH) Data Archive (NDA). Demographic and clinical outcome measures will be collected and shared using common data elements (CDEs ) from the NIH / HEAL CDE repository. Variable naming and permissible response values will be harmonized according to CDEs data dictionary specifications. Documentation to be made publicly available to the research community and will include: 1. The study protocol; 2. information sheet (provided per waiver of documentation of informed consent); 3. data collection forms/case report forms; 4. data dictionary.
Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared with the NDA repository no later than the end of the award.
Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication. The research project team and PRISM/Collaboratory Program Coordinating Center will work together in order to offer deidentified or limited data sets that will be available to the public. Where practicable, Limited Datasets (LDSs) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or reidentifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. No PHI or VA sensitive data will be shared, unless approved by VA Privacy Officers. Only authorized research personnel as approved by the ACOS in agreement with the MPIs, will have access to individually identifiable data.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Average over 6 months of follow-up, with assessments at 10 weeks and 6 months. |
| Minneapolis Veterans Affairs Medical Center |
| Principal Investigator |