RecruitingNot ApplicableNCT06500780

Equipping Patients Using Interventions for Pain and Depression

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


Sponsor

Indiana University

Enrollment

304 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (EQUIP) is testing a new care program to help Black or African American patients who have both ongoing musculoskeletal pain (such as back pain, hip, knee, or shoulder pain) and depression. The program uses phone-based support to help manage both conditions together. **You may be eligible if...** - You identify as Black or African American - You have had ongoing pain in your back, neck, hip, knee, or shoulder for at least 3 months - Your pain is moderate or worse (score of 4 or higher on a 0–10 pain scale) - You have at least mild depression (PHQ-8 score of 5 or higher) - You have consistent access to a telephone - You have an upcoming appointment with your primary care doctor (or are willing to schedule one) - You are open to trying new pain treatments **You may NOT be eligible if...** - You participated in a related previous pilot study - You have a severe medical condition (such as a recent stroke or heart attack in the last 6 months, or active cancer treatment) - You have active thoughts of suicide or severe hearing, speech, or cognitive problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCoaching and Decision Aid

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


Locations(1)

Eskenazi Health Primary Care

Indianapolis, Indiana, United States

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NCT06500780


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