Can coaching replace pills? new trial targets pain and depression in black patients
NCT ID NCT06500780
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a coaching program combined with a decision aid can help Black patients with long-term muscle and joint pain and depression use non-drug treatments like physical therapy or counseling. 304 patients will be randomly assigned to either the coaching program or usual care. The goal is to see if coaching reduces pain interference and depression symptoms over 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Coaching and decision aid (behavioral intervention)
- What this could lead to
- If successful, this could provide a practical, non-drug approach to help Black patients better manage chronic pain and depression, reducing reliance on medications.
- What could go wrong
- This is a phase 2 trial with a moderate sample size, so results may not apply broadly. The intervention is behavioral, so benefits may vary and long-term effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 304 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Eskenazi Health Primary Care
RECRUITINGIndianapolis, Indiana, 46254, United States
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