Coaching for Chronic Pain and Depression

(EQUIPD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Marianne Matthias, PHd

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Disqualifiers: Stroke, Heart failure, Cancer, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on encouraging non-drug treatments for pain, but it doesn't mention a requirement to stop existing medications.

What data supports the idea that Coaching for Chronic Pain and Depression is an effective treatment?

The available research shows that Coaching for Chronic Pain and Depression, which includes techniques like motivational interviewing, is effective in helping people manage their pain and improve their mental health. One study found that motivational interviewing helped patients change their attitudes and behaviors, which is important for managing chronic pain. Another study showed that a peer coaching program helped veterans manage their pain better by providing support and advice from others who have successfully managed their own pain. These studies suggest that this treatment can help people feel more in control of their pain and improve their quality of life. ^{1 2 3 4 5}

What safety data exists for coaching treatments for chronic pain and depression?

The available research suggests that motivational interviewing and similar coaching methods, such as decision aid coaching and nonpharmacological pain treatment coaching, are generally focused on improving patient engagement and readiness to manage chronic pain. These methods emphasize patient-centered discussions and shared decision-making, which can help reduce the risks associated with long-term opioid therapy by promoting non-opioid based treatment options. While specific safety data is not detailed in the provided research, these approaches are designed to empower patients and improve psychosocial function, suggesting a low risk of harm when used appropriately. ^{1 6 7 8 9}

Is the treatment Coaching, Decision Aid a promising treatment for chronic pain and depression?

Yes, Coaching, Decision Aid is a promising treatment for chronic pain and depression. It uses motivational interviewing to help people change their attitudes and behaviors, which can improve their ability to manage pain and enhance their quality of life. This approach can make patients more ready and motivated to stick with their treatment plans, potentially leading to better outcomes. ^{1 2 5 7 10}

Research Team

Marianne Matthias, PHd

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for Black patients with both chronic musculoskeletal pain and depression. Participants will be from an urban safety-net health system and must not have started any nonpharmacological pain treatments (NPTs) before the study.

Inclusion Criteria

Patients must identify as Black

Patients must have consistent access to a telephone

I have an appointment with my primary care doctor soon or am willing to make one.

Exclusion Criteria

Patients who previously participated in specific pilot studies or projects

Patients with severe medical conditions likely precluding participation

Patients with active suicidal ideation

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of participants' conditions before randomization

1 week

Treatment

Participants in the intervention group receive 4 coaching sessions over 12 weeks using Motivational Interviewing principles

12 weeks

4 coaching sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 3 and 6 months

6 months

Treatment Details

Interventions

• Coaching (Behavioral Intervention)
• Decision Aid (Procedure)

Trial Overview The trial tests a decision aid/coaching intervention tailored to encourage use of NPTs among Black patients with chronic pain and depression. It compares this approach against usual care in a randomized controlled setup over approximately 6 months.

Participant Groups

Group I: Coaching and Decision Aid Experimental Treatment 1 Intervention

Intervention group (Individual coaching sessions and Decision Aid)

Group II: Control Active Control 1 Intervention

Wait-list control group

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Alan Palkowitz

Indiana University

Chief Executive Officer since 2020

PhD in Chemistry from Indiana University

David Ingram

Indiana University

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Dr. Jessica Gill

National Institute of Nursing Research (NINR)

Chief Medical Officer since 2023

PhD in Nursing from Johns Hopkins University

Dr. Shannon Zenk

National Institute of Nursing Research (NINR)

Chief Executive Officer since 2020

PhD in Urban Planning and Policy Development from Rutgers University

Findings from Research

Readiness to change attitudes and behaviors is crucial for effectively managing chronic pain, and this process can be understood through the transtheoretical model (TTM), which includes stages like precontemplation, contemplation, and action.

Motivational interviewing is a valuable technique in medical consultations that helps patients weigh the pros and cons of changing their behavior, aiming to enhance their motivation and decisional balance towards adopting healthier habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Motivational readiness for chronic pain patients]. Rau, J., Petermann, F.[2021]

The ECLIPSE trial, involving 215 veterans, tested a peer coach-led pain self-management intervention over 6 months, showing promise in effectively managing chronic pain with fewer clinical resources.

This innovative peer coaching model allows patients to support each other in managing pain, potentially improving outcomes like pain intensity and self-efficacy while reducing the burden on healthcare teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a peer coach-led intervention to improve pain symptoms (ECLIPSE): Rationale, study design, methods, and sample characteristics. Matthias, MS., Daggy, J., Adams, J., et al.[2020]

The OPTI study involved 100 veterans with chronic pain and high-risk opioid use, testing a 12-week Collaborative Care intervention aimed at improving opioid safety and promoting non-drug pain management strategies.

Preliminary results suggest that the intervention, which included personalized Pain Care Plans and Motivational Interviewing sessions, may enhance the management of chronic pain and reduce reliance on prescription opioids among veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing pain treatment interventions (OPTI): A pilot randomized controlled trial of collaborative care to improve chronic pain management and opioid safety-Rationale, methods, and lessons learned. Seal, KH., Borsari, B., Tighe, J., et al.[2020]

Pain neuroscience education (PNE) and motivational interviewing (MI) are both effective short-term strategies for managing chronic pain, with PNE focusing on educating patients about the nature of their pain and MI enhancing motivation for behavior change.

Combining PNE and MI may lead to better outcomes in chronic pain management, as they complement each other by improving pain knowledge and adherence to treatment, but further clinical trials are needed to confirm if this combination is more effective than using either method alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Motivational Interviewing in Pain Neuroscience Education for People With Chronic Pain: A Practical Guide for Clinicians. Nijs, J., Wijma, AJ., Willaert, W., et al.[2020]

The CDC's 2022 guidelines encourage clinicians to carefully weigh the risks and benefits of continuing opioid therapy for chronic pain, highlighting the need for empathetic, patient-centered discussions to avoid patient abandonment.

The proposed harm-reductive framework aims to balance the risks of continuing versus discontinuing opioid therapy, fostering trust between patients and providers and promoting evidence-based, multi-modal pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harms Versus Harms: Rethinking Treatment for Patients on Long-Term Opioids. Lagisetty, P., Kertesz, S.[2023]

An online self-management program for chronic pain was developed with the active involvement of people with lived experience (PWLE), ensuring the content is relevant and sensitive to their needs.

Usability testing showed that the program, which includes eight interactive modules and motivational interviewing coaching, was highly accessible and easy to use, setting the stage for future studies on its effectiveness in helping individuals manage chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience-based design: Empowering individuals while they wait for interprofessional chronic pain care. Bosma, R., Bisson, EJ., Cooper, LK., et al.[2023]

A 4-week motivational interviewing program for 30 older adults with chronic pain significantly reduced the risk of prescription opioid misuse and substance use, while also improving self-efficacy and motivation to change.

The study suggests that motivational interviewing can be effectively implemented in outpatient settings to enhance adherence to prescription opioids among older adults at risk for misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Motivational Interviewing on Prescription Opioid Adherence Among Older Adults With Chronic Pain. Chang, YP., Compton, P., Almeter, P., et al.[2016]

The INSPIRE trial is a multicenter, randomized study designed to compare the effectiveness of shared decision making versus motivational interviewing combined with cognitive behavioral therapy for helping adults with chronic noncancer pain taper their opioid doses.

The primary outcome of the trial is the change in average daily prescribed opioid dose over 12 months, which will provide valuable insights for clinicians and policymakers aiming to reduce opioid use and improve chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a Multicenter Randomized Controlled Trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol. Edlund, MJ., Thomas, SM., Wagner, LK., et al.[2023]

This study will evaluate the effectiveness of a motivational interviewing (MI) pre-rehabilitation intervention in 160 patients with chronic musculoskeletal pain, aiming to improve long-term societal participation and reduce drop-out rates during rehabilitation.

The MI intervention consists of two sessions designed to enhance patient motivation and expectations, and its impact will be compared to usual care, providing insights into its potential benefits in pain rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nurse-led motivational interviewing of patients with chronic musculoskeletal pain in preparation of rehabilitation treatment (PREPARE) on societal participation, attendance level, and cost-effectiveness: study protocol for a randomized controlled trial. Mertens, VC., Goossens, ME., Verbunt, JA., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Motivational readiness for chronic pain patients]. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

[Impact of a motivational intervention on coping with chronic pain: results of a controlled efficacy study]. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a peer coach-led intervention to improve pain symptoms (ECLIPSE): Rationale, study design, methods, and sample characteristics. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Optimizing pain treatment interventions (OPTI): A pilot randomized controlled trial of collaborative care to improve chronic pain management and opioid safety-Rationale, methods, and lessons learned. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Integrating Motivational Interviewing in Pain Neuroscience Education for People With Chronic Pain: A Practical Guide for Clinicians. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Harms Versus Harms: Rethinking Treatment for Patients on Long-Term Opioids. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Experience-based design: Empowering individuals while they wait for interprofessional chronic pain care. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The Effect of Motivational Interviewing on Prescription Opioid Adherence Among Older Adults With Chronic Pain. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Design of a Multicenter Randomized Controlled Trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Effects of nurse-led motivational interviewing of patients with chronic musculoskeletal pain in preparation of rehabilitation treatment (PREPARE) on societal participation, attendance level, and cost-effectiveness: study protocol for a randomized controlled trial. [2021]