Equity Using Interventions for Pain and Depression - Pilot Study

NCT05695209 | Completed Results DMC

• 2 other identifiers: 16571R61NR020845
• Study Type: interventional
• Target: 30
• 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 pilot randomized controlled trial (RCT) is part of phase 1 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 pilot trial randomized 30 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system. After the baseline assessment, patients randomized to the intervention were asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions used 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 were integrated into these sessions, which facilitated discussion of these options with their PCP. The first 3 sessions ideally took place prior to the patient's next scheduled PCP visit; the final session occurred after this visit. Assessments were conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months. Patients randomized to the wait-list control group received usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they were given the DA and offered a 20-minute coaching session to walk them through it (patients could decline the coaching session).

Conditions

Chronic Pain; Depression; Health Equity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.

  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 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.

  6 months

Secondary Outcomes (16)

• Change From Baseline Patient Health Questionnaire (PHQ)-8 at 3 Months

  3 months

• Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 Months

  6 months

• Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 Months

  3 months

• Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 Months

  6 months

• Change From Baseline Pain Catastrophizing Scale at 3 Months

  3 months

Study Arms (2)

Coaching and Decision Aid

EXPERIMENTAL

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

You may not qualify if:

• Patients are excluded:
• if previously participated in the PI's past pilot study (IRB #12885) or participation as a Patient Engagement Panel member for this project,
• if medical records indicate severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure), or
• if the eligibility screener reveals (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

Location

MeSH Terms

Conditions

Chronic Pain; Depression

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Principal Investigator
• Organization: Indiana University

mmatthia@iu.edu

317-278-3154

Study Officials

• Marianne Matthias, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 23, 2023
• Study Start: June 22, 2023
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: June 11, 2025
• Results First Posted: June 11, 2025

Record last verified: 2025-06

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)