Coaching for Chronic Pain and Depression

(EQUIPD Trial)

Overseen By Jennifer Garabrant

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Stroke, Heart failure, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

304 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Black patients manage long-term musculoskeletal pain and depression without medication. It involves two groups: one receives coaching sessions (a nonpharmacological pain treatment) to explore new ways to tackle pain, while the other continues with regular care and later receives a brief coaching session. Participants should have experienced pain in areas like the back or knees for over three months and be open to trying new pain treatments. This study is part of a larger effort to explore non-drug options for pain relief. As an unphased trial, it offers a unique opportunity to explore innovative pain management strategies without medication.

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 prior data suggests that this coaching intervention is safe for patients with chronic pain and depression?

Research has shown that motivational interviewing, a technique used in coaching for chronic pain and depression, is generally safe and well-tolerated. Studies have found it can help patients manage chronic diseases by improving their involvement and outcomes. No significant negative effects have been reported from this approach.

Decision aids, tools that help people make informed healthcare choices, are also considered safe. They have been used in other health areas, such as HIV prevention, without major safety concerns. Overall, both coaching and decision aids in this context have not shown any notable safety issues in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using individual coaching sessions alongside a decision aid to help manage chronic pain and depression. Unlike typical treatments that often rely on medications and physical therapies, this approach focuses on empowering patients to make informed decisions and develop personalized coping strategies. This method could offer a more holistic way to address both the physical and emotional aspects of these conditions, potentially leading to improved long-term outcomes for patients.

What evidence suggests that this coaching intervention is effective for chronic pain and depression?

Research has shown that motivational interviewing, a technique used in the Coaching arm of this trial, can help people with chronic pain manage their pain and improve their quality of life. Studies have found that this method encourages people to follow healthcare advice more closely, leading to better outcomes for those with long-term illnesses. Health and wellness coaching, which often incorporates these techniques, has also positively impacted pain-related issues.

Regarding the Decision Aid, another component of the Coaching and Decision Aid arm in this trial, there is less direct evidence of its use specifically for chronic pain and depression. However, decision aids generally help patients make more informed healthcare choices. They explain treatment options clearly and encourage patient involvement in care, which can lead to better adherence to chosen treatments. This might improve outcomes for those dealing with both chronic pain and depression. ^{1 2 6 7 8}

Who Is on the Research Team?

Adam T Hirsh, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Coaching
• Decision Aid

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.

How Is the Trial Designed?

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+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

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]

A study involving 147 patients with chronic pain conditions showed that brief motivational interviewing by telephone significantly improved cognitive coping and emotional coping related to anxiety and anger over a 9-month period.

While the intervention did not significantly enhance self-efficacy or behavioral coping, it was particularly effective for patients with rheumatoid arthritis and ankylosing spondylitis compared to those with fibromyalgia syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact of a motivational intervention on coping with chronic pain: results of a controlled efficacy study]. Rau, J., Ehlebracht-König, I., Petermann, F.[2021]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8200683/

Motivational Interviewing: An Evidence-Based Approach for ... Effectiveness of motivational interviewing interventions on medication adherence in adults with chronic diseases: a systematic review and meta-analysis. Int ...

2. pcori.org pcori.org/research-results/2017/does-motivational-interviewing-plus-cognitive-behavioral-therapy-reduce-opioid-use-among-adults-chronic-pain-better-shared-decision-making-inspire-study

The INSPIRE Study In this study, the research team compared two approaches to help patients better manage their pain: Motivational interviewing plus cognitive ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7384647/

Health and wellness coaching positively impacts ... HWC appears to be a promising intervention to improve pain-related outcomes in a population with chronic pain.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1526590015009578

The Efficacy of Motivational Interviewing in Adults With ... In this study we investigated whether MI is effective in improving adherence, and pain and physical function for patients with chronic pain.

5. withpower.com withpower.com/trial/phase-chronic-pain-7-2024-3e845

Coaching for Chronic Pain and Depression (EQUIPD Trial) It uses motivational interviewing to help people change their attitudes and behaviors, which can improve their ability to manage pain and enhance their quality ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155174112200122X

The impact of a provider motivational interviewing-based ... Motivational interviewing (MI) has been shown to be effective in chronic disease management and could improve patient engagement and chronic pain outcomes.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06500780

Equity Using Interventions for Pain and Depression 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.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK556236/

Evidence Summary - Noninvasive Nonpharmacological ... This review focuses on noninvasive nonpharmacological treatment for chronic pain including exercise, mind-body practices, psychological therapies, ...