NCT06500780

Equipping Patients Using Interventions for Pain and Depression

Equipping Patients Using Interventions for Pain and Depression (EQUIPD) - Phase 2

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Coaching and Decision Aid	Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents

Timeline

• Start date: 2024-08-13
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2024-07-15
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States