NCT05695209: EQUIPD-Pilot

Equity Using Interventions for Pain and Depression - Pilot Study

Completed NA Results posted Last updated 11 June 2025

What this trial tests

NA trial testing Coaching and Decision Aid in Chronic Pain in 30 participants. Completed in 23 April 2024.

Timeline

22 June 2023

Primary endpoint
23 April 2024

23 April 2024

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	30
Start date	22 June 2023
Primary completion	23 April 2024
Estimated completion	23 April 2024
Sites	1 location across United States

Drugs / interventions tested

• Coaching and Decision Aid

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Depression — all drugs for Depression →
• Health Equity — all drugs for Health Equity →

Sponsor

Indiana University

Who can join

18 and older, any sex, with Chronic Pain or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months Primary · 3 months

The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.

Group	Value	95% CI
Coaching and Decision Aid	-1.02	± 1.87
Control	-0.30	± 2.24

Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 6 Months Primary · 6 months

The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.

Group	Value	95% CI
Coaching and Decision Aid	-1.75	± 2.28
Control	-1.14	± 1.51

Change From Baseline Patient Health Questionnaire (PHQ)-8 at 3 Months Secondary · 3 months

The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity.

Group	Value	95% CI
Coaching and Decision Aid	-2.36	± 5.57
Control	-0.77	± 4.44

Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 Months Secondary · 6 months

The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity.

Group	Value	95% CI
Coaching and Decision Aid	-2.15	± 4.18
Control	-0.46	± 4.75

Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 Months Secondary · 3 months

Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome).

Group	Value	95% CI
Coaching and Decision Aid	-3.29	± 5.01
Control	-0.08	± 6.30

Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 Months Secondary · 6 months

Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome).

Group	Value	95% CI
Coaching and Decision Aid	-3.23	± 3.75
Control	-0.23	± 4.40

Change From Baseline Pain Catastrophizing Scale at 3 Months Secondary · 3 months

The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome.

Group	Value	95% CI
Coaching and Decision Aid	-4.31	± 11.26
Control	3.54	± 8.78

Change From Baseline Pain Catastrophizing Scale at 6 Months Secondary · 6 months

The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome.

Group	Value	95% CI
Coaching and Decision Aid	-5.00	± 13.39
Control	-2.12	± 12.01

Change From Baseline Altarum Consumer Engagement (ACE) Measure at 3 Months Secondary · 3 months

Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement.

Group	Value	95% CI
Coaching and Decision Aid	2.64	± 8.96
Control	-2.04	± 9.16

Change From Baseline Altarum Consumer Engagement (ACE) Measure at 6 Months Secondary · 6 months

Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement.

Group	Value	95% CI
Coaching and Decision Aid	4.29	± 7.16
Control	-0.24	± 10.93

Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 Months Secondary · 3 months

The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer "yes" will be summed for analyses.

Group	Value	95% CI
Coaching and Decision Aid	0.23	± 1.96
Control	-0.46	± 1.61

Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 Months Secondary · 6 months

The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer "yes" will be summed for analyses.

Group	Value	95% CI
Coaching and Decision Aid	0.38	± 1.50
Control	0.54	± 1.94

Sponsor's own description

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 randomized 30 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system. After the baseline assessment, patients randomized to the intervention were asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions used 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 were integrated into these sessions, which facilitated discussion of these options with their PCP. The first 3 sessions ideally took place prior to the patient's next scheduled PCP visit; the final session occurred after this visit. Assessments were conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months.

Patients randomized to the wait-list control group received usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they were given the DA and offered a 20-minute coaching session to walk them through it (patients could decline the coaching session).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Equity Using Interventions for Pain and Depression (EQUIPD): A pilot randomized trial.
   Matthias MS, Burgess DJ, Daggy JK, Donnelly CE, et al · · 2025 · PMID 40010678 · DOI 10.1016/j.jpain.2025.105353