Helping Black patients manage chronic pain and depression
Equipping Patients Using Interventions for Pain and Depression (EQUIPD) - Phase 2
This study is testing a new coaching program to help Black patients with chronic pain and depression stick to non-drug treatments and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06500780 on ClinicalTrials.gov |
What this trial studies
This project is part of the NIH HEAL initiative and focuses on a randomized controlled trial designed to test a decision aid and coaching intervention tailored for Black patients suffering from chronic musculoskeletal pain and depression. The trial will involve 304 patients from an urban safety-net health system, who will be randomized into two groups: one receiving the intervention and the other receiving standard care. The intervention includes four coaching sessions over approximately 12 weeks, utilizing Motivational Interviewing principles to enhance patient engagement with nonpharmacological pain treatments. The goal is to improve adherence to these treatments and overall health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are Black or African American patients experiencing chronic musculoskeletal pain and depression.
Not a fit: Patients who do not identify as Black or African American or those with pain conditions not meeting the study criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve pain management and mental health outcomes for Black patients with chronic pain and depression.
How similar studies have performed: Other studies have shown promise in using decision aids and coaching for similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Eligible patients must * have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for ≥3 months, * have at least moderate pain intensity and interference with function, defined by a score ≥4 (possible range: 0-10) on the Pain, Enjoyment of Life and General Activity scale (PEG), a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity, * have at least mild depression, defined as PHQ-8 score ≥5, * identify as Black or African American, * have consistent access to a telephone, * indicate openness to new pain treatments, and * have a scheduled appointment with their PCP in the next approximate 2-4 months or be willing to schedule one Exclusion Criteria: Patients are excluded: * if previously participated in Dr. Matthias' past pilot study (IRB #12885), the pilot RCT for this project (IRB #16571), or are participating as a Patient Engagement Panel member for this project (Aim 1.1), * if the eligibility screener or medical records indicate severe medical conditions likely precluding participation (e.g. stroke in the last 6 months, hospitalized with congestive heart failure or a heart attack in the last 6 months, cancer other than skin cancer and receiving active treatment), or * if the eligibility screener or medical records reveal (1) active suicidal ideation, or (2) severe hearing/speech or cognitive impairment.
Where this trial is running
Indianapolis, Indiana
- Eskenazi Health Primary Care — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Adam T Hirsh, PhD — Indiana University
- Study coordinator: Research Specialist
- Email: equipd@regenstrief.org
- Phone: 317-274-9402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.