NCT07541599

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
32mo left

Started Apr 2026

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Dec 2028

Study Start

First participant enrolled

April 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

April 12, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

chronic paincomplementary therapiesmodels, biopsychosocialruralVeteran

Outcome Measures

Primary Outcomes (1)

  • 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, 3 and 6 months.

Secondary Outcomes (16)

  • Pain intensity

    Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.

  • Pain impact

    Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.

  • Quality of life

    Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.

  • Quality of life

    Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.

  • Physical functioning

    Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.

  • +11 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: RAMP Program

Usual Care

NO INTERVENTION

Interventions

RAMP ProgramBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) 18 years of age or older (2) rural-dwelling based on U.S. Health Services Research Administration Criteria (3) 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; (4) self-reported pain on at least most days in the past 3 months, (5) Brief Pain Inventory Interference subscale score ≥ 4/10; (6) access to a device with internet, (7) willingness to engage in intervention-specific procedures (e.g., meet remotely online for sessions), and (8) an email address listed in the EHR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VAMC

Minneapolis, Minnesota, 55417, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roni Evans, DC, PhD, MS

    University of Minnesota

    PRINCIPAL INVESTIGATOR
  • Katherine Hadlandsmyth, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR
  • Diana Burgess, PhD

    Minneapolis Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Burgess, PhD

CONTACT

Lee Cross, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2026

First Posted

April 21, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
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.
Access Criteria
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.

Locations