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Equipping Patients Using Interventions for Pain and Depression

Equipping Patients Using Interventions for Pain and Depression (EQUIPD) - Phase 2

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "After the baseline assessment, patients randomized to the intervention will be asked to participate in 4 coaching sessions over approximately 12 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a guide to treatment choices and coaching help Black patients with long-term muscle or joint pain and depression use pain treatments without medicine. Patients are assigned by chance to get four coaching sessions over about 12 weeks or their usual care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Identify as Black or African American.
  • Have pain in the lower back, neck, hip, knee, or shoulder for at least 3 months.
  • Have at least moderate pain that affects daily life, with a score of 4 or higher on the PEG pain survey.
  • Have at least mild depression, with a score of 5 or higher on the PHQ-8 depression survey.
  • Have regular access to a telephone.
  • Be open to trying new pain treatments.
  • Have a visit with your primary care provider planned in about 2 to 4 months, or be willing to schedule one.

Who can't join

  • Took part in Dr. Matthias’ earlier pilot study or this project’s pilot trial, or serve on this project’s patient panel.
  • Have a serious health problem that would likely prevent taking part. Examples include a stroke in the past 6 months, a hospital stay for heart failure or a heart attack in the past 6 months, or cancer being treated now other than skin cancer.
  • Have current thoughts of suicide.
  • Have severe problems with hearing, speech, memory, or thinking.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

IN