Equity Using Interventions for Pain and Depression
Purpose
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 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 pilot trial will aim to enroll up to 355 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system (Eskenazi) in order to randomize at least 304 patients. 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.
Conditions
- Chronic Pain
- Musculoskeletal Pain
- Depression
- Health Equity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
- Masking Description
- Baseline assessments are conducted prior to randomization (Baseline assessor will not know the randomization assignment).
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Coaching and Decision Aid |
Intervention group (Individual coaching sessions and Decision Aid) |
|
|
No Intervention Control |
Wait-list control group |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Indiana University
