Equity Using Interventions for Pain and Depression - Pilot Study

Not Applicable

Completed

• Conditions: Chronic Pain; Health Equity; Depression
• Interventions: Behavioral: Coaching and Decision Aid

• Registration Number: NCT05695209
• Lead Sponsor: Indiana University

Brief Summary

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 randomize 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 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-23
• Study Start: 2023-06-22
• Primary Completion: 2024-04-23
• Study Completion: 2024-04-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coaching and Decision Aid	Coaching and Decision Aid	Individual coaching sessions and Decision Aid

Primary Outcome Measures

Name	Time	Method
Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 6 months	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.
Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Patient Health Questionnaire (PHQ)-8 at 3 months	3 months	The PHQ-8 is a widely-used, validated 8-item measure of depression severity.
Change from Baseline Patient Health Questionnaire (PHQ)-8 at 6 months	6 months	The PHQ-8 is a widely-used, validated 8-item measure of depression severity.
Change from Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 months	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).
Change from Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 months	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).
Change from Baseline Pain Catastrophizing Scale at 3 months	3 months	The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response.
Change from Baseline Pain Catastrophizing Scale at 6 months	6 months	The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response.
Change from Baseline Altarum Consumer Engagement (ACE) Measure at 3 months	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.
Change from Baseline Altarum Consumer Engagement (ACE) Measure at 6 months	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.
Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 months	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.
Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 months	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.
Change from Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 months	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.
Change from Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 months	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.
Change from Baseline CollaboRATE at 3 months	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
Change from Baseline CollaboRATE at 6 months	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
Change from Baseline Working Alliance Inventory (WAI) Client Short Form at 3 months	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.
Change from Baseline Working Alliance Inventory (WAI) Client Short Form at 6 months	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.

Trial Locations

Locations (1)

Eskenazi Health Primary Care; 🇺🇸 Indianapolis, Indiana, United States