Equipping Patients Using Interventions for Pain and Depression

NCT ID: NCT06500780

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-13
• Study Completion Date: 2027-05-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Coaching and Decision Aid

Intervention group (Individual coaching sessions and Decision Aid)

Group Type: EXPERIMENTAL

Coaching and Decision Aid

Intervention Type: BEHAVIORAL

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

Control

Wait-list control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Coaching and Decision Aid

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Adam Todd Hirsh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam T Hirsh, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Eskenazi Health Primary Care

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Research Specialist

Role: CONTACT

equipd@regenstrief.org

317-274-9402

Jennifer Garabrant

Role: CONTACT

jwilkers@iu.edu

317-278-2510

Facility Contacts

Research Specialist

Role: primary

equipd@regenstrief.org

317-274-9402

Other Identifiers

4R33NR020845-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22412

Identifier Type: -

Identifier Source: org_study_id