Equipping Patients Using Interventions for Pain and Depression

Indiana University304 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

304

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 3 months

The pain interference score averages seven ratings, 0 (does not interfere) to 10 (completely interferes).

Time frame: 3 months

Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 6 months

The pain interference score averages seven ratings, 0 (does not interfere) to 10 (completely interferes).

Time frame: 6 months

Change from Baseline Patient Health Questionnaire (PHQ)-8 at 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).

Time frame: 3 months

Change from Baseline Patient Health Questionnaire (PHQ)-8 at 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).

Time frame: 6 months

Secondary Outcomes

Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 3 months

Anxiety will be measured with the 7 item Generalized Anxiety Disorder (GAD)-7 that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).

Time frame: 3 months

Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 6 months

Anxiety will be measured with the 7 item Generalized Anxiety Disorder (GAD)-7 that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).

Time frame: 6 months

Change from Baseline Pain Catastrophizing Scale at 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).

Time frame: 3 months

Change from Baseline Pain Catastrophizing Scale at 6 months

Time frame: 6 months

Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 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.

Time frame: 3 months

Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 months

Time frame: 6 months

Change from Baseline Altarum Consumer Engagement (ACE) Measure at 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 ranging from 0 (strongly disagree) to 4 (strongly agree).

Time frame: 3 months

Change from Baseline Altarum Consumer Engagement (ACE) Measure at 6 months

Time frame: 6 months

Change from Baseline Decisional Conflict Scale (DCS) at 3 months

Decisional conflict will be measured with the 16-item Decisional Conflict Scale that measures personal perceptions of a) uncertainty in choosing options, b) modifiable factors contributing to uncertainty, and c) effective decision making on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).

Time frame: 3 months

Change from Baseline Decisional Conflict Scale (DCS) at 6 months

Time frame: 6 months

Equipping Patients Using Interventions for Pain and Depression

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts