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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Indiana
Eskenazi Health Primary Care
RECRUITING
Indianapolis
Contact Information
Primary
Research Specialist
equipd@regenstrief.org
317-274-9402
Backup
Jennifer Garabrant
jwilkers@iu.edu
317-278-2510
Time Frame
Start Date: 2024-08-13
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 304
Treatments
Experimental: Coaching and Decision Aid
Intervention group (Individual coaching sessions and Decision Aid)
No_intervention: Control
Wait-list control group
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Nursing Research (NINR)
Leads: Indiana University

This content was sourced from clinicaltrials.gov

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