Chronic PainRAMPNCT07541599
Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention - UH3
A study testing RAMP Program in people with Chronic Pain, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- RAMP Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Minneapolis VAMC
Minneapolis, Minnesota, 55417
Diana Burgess, PhD, 612-467-1591, diana.burgess@va.gov
Lee Cross, MPH, 612-629-7568, lee.cross@va.gov
About this study
Official title: Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- RAMP Program
- Keywords
- chronic pain, complementary therapies, models, biopsychosocial, rural, Veteran
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAMP ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: RAMP Program |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain interference
Measured using the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning.
Measured: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Secondary outcomes (16)
Pain intensity
Measured using the Brief Pain Inventory (BPI) intensity score. Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Average over 6 months of follow-up, with assessments at 10 weeks and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Apr 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Diana J. Burgess, Minneapolis Veterans Affairs Medical Center
- Investigators
- Roni Evans, DC, PhD, MS, Principal investigator, University of MinnesotaKatherine Hadlandsmyth, PhD, Principal investigator, University of IowaDiana Burgess, PhD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541599
- Sponsor's protocol ID
- 4UH3NR020929-02
- Acronym
- RAMP
- Status last verified
- May 2026
- First submitted
- 12 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention
- ClinicalTrials.gov ID
- NCT07541599
- Acronym / sponsor ID
- RAMP / 4UH3NR020929-02
- Conditions
- Chronic Pain
- Keywords
- chronic pain, complementary therapies, models, biopsychosocial, rural, Veteran
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: RAMP Program |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAMP ProgramRAMP 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. | Behavioural | Intervention |
Primary outcome
Pain interference
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Measured using the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning.
16 secondary outcomes
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.
Overall improvement
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
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Substance use
Time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
Adverse events
Time frame: Average over 6 months of follow-up, with assessments at 10 weeks and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roni Evans, DC, PhD, MS principal investigator
University of Minnesota
Katherine Hadlandsmyth, PhD principal investigator
University of Iowa
Diana Burgess, PhD principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAMP Program in people with Chronic Pain, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Burgess, PhD (612-467-1591, diana.burgess@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain interference (time frame: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.