Equipping Patients Using Interventions for Pain and Depression (EQUIPD) - Phase 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Indiana University
- Enrollment
- 304
- Locations
- 1
- Primary Endpoint
- Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 3 months
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
Baseline assessments are conducted prior to randomization (Baseline assessor will not know the randomization assignment).
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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 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 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.
Arms & Interventions
Control
Wait-list control group
Coaching and Decision Aid
Intervention group (Individual coaching sessions and Decision Aid)
Intervention: Coaching and Decision Aid (Behavioral)
Outcomes
Primary Outcomes
Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 3 months
Time Frame: 3 months
The pain interference score averages seven ratings, 0 (does not interfere) to 10 (completely interferes).
Change from Baseline Patient Health Questionnaire (PHQ)-8 at 3 months
Time Frame: 3 months
The Patient Health Questionnaire (PHQ)-8 is a widely-used, validated 8-item measure of depression severity that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 6 months
Time Frame: 6 months
The pain interference score averages seven ratings, 0 (does not interfere) to 10 (completely interferes).
Change from Baseline Patient Health Questionnaire (PHQ)-8 at 6 months
Time Frame: 6 months
The Patient Health Questionnaire (PHQ)-8 is a widely-used, validated 8-item measure of depression severity that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
Secondary Outcomes
- Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 3 months(3 months)
- Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 6 months(6 months)
- Change from Baseline Pain Catastrophizing Scale at 3 months(3 months)
- Change from Baseline Pain Catastrophizing Scale at 6 months(6 months)
- Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 months(3 months)
- Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 months(6 months)
- Change from Baseline Altarum Consumer Engagement (ACE) Measure at 3 months(3 months)
- Change from Baseline Altarum Consumer Engagement (ACE) Measure at 6 months(6 months)
- Change from Baseline Decisional Conflict Scale (DCS) at 3 months(3 months)
- Change from Baseline Decisional Conflict Scale (DCS) at 6 months(6 months)
Investigators
Adam Todd Hirsh
Professor
Indiana University