Equity Using Interventions for Pain and Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-22

Study Completion Date

2024-04-23

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Pain Depression Health Equity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Coaching and Decision Aid

Individual coaching sessions and Decision Aid

Group Type EXPERIMENTAL

Coaching and Decision Aid

Intervention Type BEHAVIORAL

Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents

Control

Wait-list control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Coaching and Decision Aid

Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No