Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06500780

Equipping Patients Using Interventions for Pain and Depression

Led by Indiana University · Updated on 2025-11-25

304

Participants Needed

1

Research Sites

145 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

N

National Institute of Nursing Research (NINR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Equipping Patients Using Interventions for Pain and Depression

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) lasting 3 months or more
  • Have at least moderate pain intensity and interference with function (score of 4 or higher on the PEG scale)
  • Have at least mild depression (PHQ-8 score of 5 or higher)
  • Identify as Black or African American
  • Have consistent access to a telephone
  • Are open to trying new pain treatments
  • Have a scheduled appointment with their primary care provider within the next 2 to 4 months or are willing to schedule one
Not Eligible

You will not qualify if you...

  • Previously participated in related past studies or as a Patient Engagement Panel member for this project
  • Have severe medical conditions likely preventing participation, such as recent stroke, recent hospitalization for congestive heart failure or heart attack within the last 6 months, or active cancer treatment (excluding skin cancer)
  • Have active suicidal thoughts
  • Have severe hearing, speech, or cognitive impairments

AI-Screening

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Trial Site Locations

Total: 1 location

1

Eskenazi Health Primary Care

Indianapolis, Indiana, United States, 46254

Actively Recruiting

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Research Team

R

Research Specialist

CONTACT

J

Jennifer Garabrant

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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