Equity Using Interventions for Pain and Depression

Launched by INDIANA UNIVERSITY · Jul 8, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Equity Using Interventions for Pain and Depression," is designed to help Black patients who are struggling with both chronic musculoskeletal pain and depression. The goal of the study is to test a new program that includes coaching sessions and a decision aid to encourage these patients to explore and stick with non-drug treatments for their pain. Researchers aim to enroll up to 355 eligible participants from a local health system, focusing on individuals who have been dealing with pain for at least three months and have at least mild depression.

If you qualify for the study, you will be randomly assigned to either the coaching group or a wait-list control group. If you're in the coaching group, you'll participate in four sessions over about 12 weeks, where you'll discuss your pain management goals and learn about different treatment options with the help of a coach. If you're in the control group, you'll receive regular care and assessments but will have to wait to access the coaching and decision aid after completing the study assessments. This trial is important because it seeks to improve health equity by tailoring support specifically for Black patients facing these challenges.

Gender

ALL

Eligibility criteria

• 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.