Helping Black patients manage chronic pain and depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.