Coaching and Decision Aid for Chronic Pain and Depression

This study is testing a program called "Coaching and Decision Aid" for Black patients who have both long-lasting (chronic) musculoskeletal pain and depression. This program involves four coaching sessions over about 12 weeks, along with tools to help you make decisions about your care. The goal is to see if this program helps you use and stick with non-drug pain treatments. We are looking for 304 participants aged 18 or older who have had musculoskeletal pain in their back, neck, hip, knee, or shoulder for at least three months, and whose pain is moderate or severe, affecting their daily life. We will measure how much your pain interferes with your life and your depression symptoms at 3 and 6 months to see if the program is successful. The current recruitment status is unclear.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to either receive the intervention or not. The study plans to enroll 304 participants.
What's involved
If you are in the intervention group, you would participate in 4 coaching sessions over approximately 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your pain interference and depression symptoms will be measured at 3 months and 6 months after starting the study.

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NCT06500780

Equipping Patients Using Interventions for Pain and Depression

Recruiting
NAAges 18+InterventionalHealth services
Indiana University
~304 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Coaching and Decision Aid

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 3 months
Measured over 3 months
+3 more outcomes measured
Chronic Pain
Musculoskeletal Pain
Depression
Health Equity
1 sites across 1 states
Indiana1
  • Adam T Hirsh, PhD · PRINCIPAL_INVESTIGATOR · Indiana University

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Eligibility criteria

Inclusion

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

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.
  • Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 3 months3 months

    The pain interference score averages seven ratings, 0 (does not interfere) to 10 (completely interferes).

  • Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 6 months6 months

    The pain interference score averages seven ratings, 0 (does not interfere) to 10 (completely interferes).

  • Change from Baseline Patient Health Questionnaire (PHQ)-8 at 3 months3 months

    The Patient Health Questionnaire (PHQ)-8 is a widely-used, validated 8-item measure of depression severity that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).

  • Change from Baseline Patient Health Questionnaire (PHQ)-8 at 6 months6 months

    The Patient Health Questionnaire (PHQ)-8 is a widely-used, validated 8-item measure of depression severity that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).