Equipping Patients Using Interventions for Pain and Depression

NCT06500780 | Recruiting DMC

• 2 other identifiers: 224124R33NR020845-02
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

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

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

  3 months

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

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

  6 months

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

  3 months

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

  6 months

Secondary Outcomes (10)

• Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 3 months

  3 months

• Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 6 months

  6 months

• Change from Baseline Pain Catastrophizing Scale at 3 months

  3 months

• Change from Baseline Pain Catastrophizing Scale at 6 months

  6 months

• Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 months

  3 months

Other Outcomes (2)

• Change from Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 months

  3 months

• Change from Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 months

  6 months

Study Arms (2)

Coaching and Decision Aid

EXPERIMENTAL

Intervention group (Individual coaching sessions and Decision Aid)

Behavioral: Coaching and Decision Aid

Control

NO INTERVENTION

Wait-list control group

Interventions

Coaching and Decision Aid BEHAVIORAL

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

Coaching and Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Eskenazi Health Primary Care

Indianapolis, Indiana, 46254, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain; Depression

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Adam T Hirsh, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Specialist

CONTACT

317-274-9402; equipd@regenstrief.org

Jennifer Garabrant

CONTACT

317-278-2510; jwilkers@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Baseline assessments are conducted prior to randomization (Baseline assessor will not know the randomization assignment).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: At the time of publication of the primary manuscript
• Access Criteria: Implementation of the plan will follow the HEAL Public Access and Data Sharing Policy.

Locations

US (1)