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NCT05695209 | Active, not recruiting | Chronic Pain


Equity Using Interventions for Pain and Depression - Pilot Study
Sponsor:

Indiana University

Information provided by (Responsible Party):

Marianne S. Matthias

Brief Summary:

This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This pilot randomized controlled trial (RCT) is part of phase 1 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 pilot trial will aim to enroll up to 40 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system with the end goal of at least 30 patients completing the trial. 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 along with a 20-minute coaching session to walk them through it (patients may decline the coaching session or schedule for a future time).

Condition or disease

Chronic Pain

Depression

Health Equity

Intervention/treatment

Coaching and Decision Aid

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 30 participants
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Equity Using Interventions for Pain and Depression (EQUIPD) - Phase 1
Actual Study Start Date : June 22, 2023
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024
Arm Intervention/treatment

Experimental: Coaching and Decision Aid

Individual coaching sessions and Decision Aid

No Intervention: Control

Wait-list control group

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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,
    • 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
    Exclusion Criteria
    • Patients are excluded
      • if previously participated in the PI's past pilot study (IRB #12885) or participation as a Patient Engagement Panel member for this project,
      • if medical records indicate severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure), or
      • if the eligibility screener reveals (1) active suicidal ideation, or (2) severe hearing/speech or cognitive impairment.

Equity Using Interventions for Pain and Depression - Pilot Study

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Equity Using Interventions for Pain and Depression - Pilot Study

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Locations


Not yet recruiting

United States, Indiana

Eskenazi Health Primary Care

Indianapolis, Indiana, United States, 46254

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