Equipping Patients Using Interventions for Pain and Depression

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06500780
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pain
  • Depression
  • Health Equity
  • Musculoskeletal Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Coaching and Decision Aid — BEHAVIORAL
    Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents

Study Details

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.

Key Dates

Start date
Aug 13, 2024
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
304 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Coaching and Decision Aid
    Intervention group (Individual coaching sessions and Decision Aid)
  • No Intervention: Control
    Wait-list control group

Primary Outcome Measure

Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 3 months [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Eskenazi Health Primary CareIndianapolisIndiana46254
Research Specialist
[email protected]
317-274-9402
Adam T Hirsh, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Eskenazi Health Primary Care· Indianapolis, IN

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