Equity Using Interventions for Pain and Depression - Pilot Randomized Controlled Trial (EQUIPD-Pilot)

January 20, 2023 updated by: Marianne S. Matthias, Indiana University

Equity Using Interventions for Pain and Depression (EQUIPD) - Phase 1

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 will aim to enroll up to 40 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system with the end goal of at least 30 patients completing the trial. 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 along with a 20-minute coaching session to walk them through it (patients may decline the coaching session or schedule for a future time).

Study Overview

Status

Not yet recruiting

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Eskenazi Health Primary Care
        • Contact:
        • Principal Investigator:
          • Marianne Matthias, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 moderate depression, defined as PHQ-8 score ≥10,
  • 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

Exclusion Criteria:

Patients are excluded:

  • if previously participated in the PI's past pilot study (IRB #12885) or participation as a Patient Engagement Panel member for this project,
  • if medical records indicate severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure), or
  • if the eligibility screener reveals (1) active suicidal ideation, or (2) severe hearing/speech or cognitive impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Wait-list control group
Experimental: Coaching and Decision Aid
Individual coaching sessions and Decision Aid
Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
3 months
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 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Brief Pain Inventory (BPI) Intensity Scale at 3 months
Time Frame: 3 months
This pain intensity scale has 4 items with ratings from 0 (no pain) to 10 (pain as bad as you can imagine).
3 months
Change from Baseline Brief Pain Inventory (BPI) Intensity Scale at 6 months
Time Frame: 6 months
This pain intensity scale has 4 items with ratings from 0 (no pain) to 10 (pain as bad as you can imagine).
6 months
Change from Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form at 3 months
Time Frame: 3 months
The PROMIS Sleep Disturbance Short Form assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep using 6 items with varying 5 point Likert scales.
3 months
Change from Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form at 6 months
Time Frame: 6 months
The PROMIS Sleep Disturbance Short Form assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep using 6 items with varying 5 point Likert scales.
6 months
Change from Baseline Sleep Duration at 3 months
Time Frame: 3 months
This is a single question asking about the number of hours and minutes of actual sleep in the last month.
3 months
Change from Baseline Sleep Duration at 6 months
Time Frame: 6 months
This is a single question asking about the number of hours and minutes of actual sleep in the last month.
6 months
Change from Baseline Patient Health Questionnaire (PHQ)-8 at 3 months
Time Frame: 3 months
The PHQ-8 is a widely-used, validated 8-item measure of depression severity.
3 months
Change from Baseline Patient Health Questionnaire (PHQ)-8 at 6 months
Time Frame: 6 months
The PHQ-8 is a widely-used, validated 8-item measure of depression severity.
6 months
Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 3 months
Time Frame: 3 months
Anxiety will be measured with the 7 item GAD-7.
3 months
Change from Baseline Pain Catastrophizing Scale at 3 months
Time Frame: 3 months
The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response.
3 months
Change from Baseline Pain Catastrophizing Scale at 6 months
Time Frame: 6 months
The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response.
6 months
Change from Baseline Altarum Consumer Engagement (ACE) Measure at 3 months
Time Frame: 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. Items are assessed on a 5-point Likert scale.
3 months
Change from Baseline Altarum Consumer Engagement (ACE) Measure at 6 months
Time Frame: 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. Items are assessed on a 5-point Likert scale.
6 months
Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 months
Time Frame: 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.
3 months
Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 months
Time Frame: 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.
6 months
Change from Baseline Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) measure at 3 months
Time Frame: 3 months
Tobacco, alcohol, and drug use, as well as prescription medication misuse will be assessed using this 4-item screening tool.
3 months
Change from Baseline Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) measure at 6 months
Time Frame: 6 months
Tobacco, alcohol, and drug use, as well as prescription medication misuse will be assessed using this 4-item screening tool.
6 months
Change from Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 months
Time Frame: 3 months
Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit.
3 months
Change from Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 months
Time Frame: 6 months
Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit.
6 months
Change from Baseline CollaboRATE at 3 months
Time Frame: 3 months
Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment
3 months
Change from Baseline CollaboRATE at 6 months
Time Frame: 6 months
Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment
6 months
Change from Baseline Working Alliance Inventory (WAI) Client Short Form at 3 months
Time Frame: 3 months
The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers.
3 months
Change from Baseline Working Alliance Inventory (WAI) Client Short Form at 6 months
Time Frame: 6 months
The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers.
6 months
Perceived Discrimination in Healthcare Scale
Time Frame: Baseline
We will measure perceived discrimination in healthcare settings with the 7-item "Perceived Discrimination in Healthcare" Scale.
Baseline
Change from Baseline PROMIS Physical Function Short Form 6b at 3 months
Time Frame: 3 months
Physical functioning will be assessed with the PROMIS Physical Function Short Form 6b which assesses universal physical functioning with a 6-item, self-report scale.
3 months
Change from Baseline PROMIS Physical Function Short Form 6b at 6 months
Time Frame: 6 months
Physical functioning will be assessed with the PROMIS Physical Function Short Form 6b which assesses universal physical functioning with a 6-item, self-report scale.
6 months
Change from Baseline Patient Global Impression of Change (PGIC) at 3 months
Time Frame: 3 months
Patient-reported impression of change will be measured using the PGIC which is a one-item measure reflecting a patient's perception of change after the start of an intervention.
3 months
Change from Baseline Patient Global Impression of Change (PGIC) at 6 months
Time Frame: 6 months
Patient-reported impression of change will be measured using the PGIC which is a one-item measure reflecting a patient's perception of change after the start of an intervention.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marianne Matthias, PhD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. All HEAL Initiative award recipients, regardless of the amount of direct costs requested for any one year, are required to comply with the HEAL Public Access and Data Sharing Policy, which also aligns with the NIH Policy for Data Management and Sharing (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html). HEAL award recipients must following all requirements and timelines developed through the HEAL Initiative Data Ecosystem, as described in HEAL's compliance guidance (https://heal.nih.gov/data/complying-heal-data-sharing-policy).

IPD Sharing Time Frame

At the time of publication of the primary manuscript

IPD Sharing Access Criteria

Implementation of the plan will follow the HEAL Public Access and Data Sharing Policy.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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