Equity Using Interventions for Pain and Depression

Not Applicable

Recruiting

• Conditions: Chronic Pain; Health Equity; Musculoskeletal Pain; Depression
• Interventions: Behavioral: Coaching and Decision Aid

• Registration Number: NCT06500780
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Study Start: 2024-08-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 304

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coaching and Decision Aid	Coaching and Decision Aid	Intervention group (Individual coaching sessions and Decision Aid)

Primary Outcome Measures

Name	Time	Method
Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 3 months	3 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 months	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).
Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 6 months	6 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 6 months	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).

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Altarum Consumer Engagement (ACE) Measure at 3 months	3 months	Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Items are assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 3 months	3 months	Anxiety will be measured with the 7 item Generalized Anxiety Disorder (GAD)-7 that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 6 months	6 months	Anxiety will be measured with the 7 item Generalized Anxiety Disorder (GAD)-7 that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
Change from Baseline Pain Catastrophizing Scale at 3 months	3 months	The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time).
Change from Baseline Pain Catastrophizing Scale at 6 months	6 months	The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time).
Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 months	3 months	The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer "yes" will be summed for analyses.
Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 months	6 months	The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer "yes" will be summed for analyses.
Change from Baseline Altarum Consumer Engagement (ACE) Measure at 6 months	6 months	Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Items are assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
Change from Baseline Decisional Conflict Scale (DCS) at 3 months	3 months	Decisional conflict will be measured with the 16-item Decisional Conflict Scale that measures personal perceptions of a) uncertainty in choosing options, b) modifiable factors contributing to uncertainty, and c) effective decision making on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
Change from Baseline Decisional Conflict Scale (DCS) at 6 months	6 months	Decisional conflict will be measured with the 16-item Decisional Conflict Scale that measures personal perceptions of a) uncertainty in choosing options, b) modifiable factors contributing to uncertainty, and c) effective decision making on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).

Trial Locations

Locations (1)

Eskenazi Health Primary Care; 🇺🇸 Indianapolis, Indiana, United States