Recruiting

Interventions for Pain

Sponsor:

Indiana University

Code:

NCT06500780

Conditions

Chronic Pain

Musculoskeletal Pain

Depression

Health Equity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coaching and Decision Aid

Study Details

Brief summary:

This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This randomized controlled trial (RCT) is phase 2 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (NPTs).

This 2-arm trial will randomize 304 patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system (Eskenazi). After the baseline assessment, patients randomized to the intervention will be asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions will use Motivational Interviewing principles to foster openness to NPTs and self-efficacy by helping patients identify their goals and priorities, understand their NPT options, prepare them to discuss and choose options with their primary care providers (PCPs), and reinforce these choices to foster maintenance of these changes. DA contents will be integrated into these sessions, which will facilitate discussion of these options with their PCP. The first 3 sessions take place prior to the patient's next scheduled PCP visit; the final session occurs after this visit. Assessments will be conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months.

Patients randomized to the wait-list control group will receive usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they will then be given the DA and offered a 20-minute coaching session to walk them through it.

Conditions

Chronic Pain

Musculoskeletal Pain

Depression

Health Equity

Study ID

NCT06500780

Start date

Aug 13, 2024

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

304 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Coaching and Decision Aid

Intervention group (Individual coaching sessions and Decision Aid)

no intervention: Control

Wait-list control group

Interventions

Coaching and Decision Aid

Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents

Primary outcome measure

  • Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 3 months [ Time Frame: 3 months ]
  • Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 6 months [ Time Frame: 6 months ]
  • Change from Baseline Patient Health Questionnaire (PHQ)-8 at 3 months [ Time Frame: 3 months ]
  • Change from Baseline Patient Health Questionnaire (PHQ)-8 at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Eskenazi Health Primary Care

Recruiting

Indianapolis, Indiana, United States, 46254

Contacts

Principal Investigator:

Adam T Hirsh, PhD

More Information

Sponsor

Indiana University

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • chronic pain
  • depression
  • health equity
  • shared decision making
  • decision aid
  • depressive symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Indiana University on 2026-06-09.