Status:
RECRUITING
Equipping Patients Using Interventions for Pain and Depression
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Chronic Pain
Musculoskeletal Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT06500780
Start Date
August 13 2024
End Date
May 31 2027
Last Update
November 25 2025
Active Locations (1)
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1
Eskenazi Health Primary Care
Indianapolis, Indiana, United States, 46254