Mindfulness + Pain Management Visits for Chronic Pain

Recruiting at 2 trial locations

Overseen By Hannah Pfeffer, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Opioids

Disqualifiers: Cancer, Suicidal intent, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of mindfulness techniques and personalized pain management visits in improving well-being and reducing opioid reliance for individuals with chronic pain. Participants are divided into two groups: one attends both mindfulness sessions (Mindfulness-Oriented Recovery Enhancement) and regular pain management visits, while the other participates only in pain management visits. Eligible participants have experienced chronic pain for at least three months and are currently on long-term opioid therapy.

As an unphased trial, this study provides a unique opportunity to explore innovative approaches to managing chronic pain.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must be on long-term opioid therapy, so you may need to continue your opioid medication.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Mindfulness-Oriented Recovery Enhancement (MORE) is generally safe for individuals with chronic pain. Studies have found that MORE can help manage opioid misuse by teaching mindfulness techniques. These techniques increase awareness of cravings and improve control over them, while also promoting a calm and non-reactive state of mind. Although detailed safety data specifically for MORE is lacking, its use in various studies suggests it is well-tolerated.

Primary care providers lead the chronic pain management visits, focusing on tailoring pain management to each individual's needs. While specific safety data for these visits is not available, they involve standard care practices, which are typically safe and well-accepted for treating chronic pain.

Overall, both treatments appear safe based on the available evidence, though more specific data would provide a clearer picture. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining Mindfulness-Oriented Recovery Enhancement (MORE) with patient-centered chronic pain management because it offers a fresh approach to treating chronic pain. Unlike conventional treatments like medication or physical therapy, this approach integrates mindfulness, which helps patients manage pain by focusing on the present and reducing stress. It's unique because MORE not only addresses the physical aspects of pain but also targets emotional and cognitive responses, potentially offering a more holistic and sustainable way to manage chronic pain. By pairing mindfulness with personalized care from primary providers, this method could enhance the effectiveness of traditional pain management strategies.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that Mindfulness-Oriented Recovery Enhancement (MORE) effectively treats chronic pain and reduces problems related to opioid use. Studies indicate that MORE can lessen pain and decrease issues for long-term opioid users. It combines mindfulness (paying attention to the present moment), skills to boost positive feelings, and rethinking situations to improve well-being. Multiple clinical trials have supported its ability to ease pain and reduce opioid misuse. In this trial, participants will either receive patient-centered chronic pain management visits alone or attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks in addition to these visits. This suggests that MORE could be a promising option for managing chronic pain and reducing harm from opioids. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic pain who are currently on long-term opioid therapy. It's aimed at those experiencing substance use disorders, neurologic symptoms, or mental illness related to narcotic use. Specific eligibility criteria were not provided.

Inclusion Criteria

I have been using opioids for 3 months or more.

Score >=9 on the Current Opioid Misuse Measure OR lifetime psychiatric or substance use disorder diagnosis OR benzodiazepine use OR history of overdose OR physician determination that risks of opioid use may outweigh the benefits of opioid use

Score >=3 on the Pain Enjoyment General Activity scale

Exclusion Criteria

Active suicidal intent, schizophrenia, psychotic disorder

I have practiced mindfulness through specific programs.

I have chronic pain because of my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks and patient-centered chronic pain management visits

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessed at 3-, 6-, 9-, and 12-months follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness-Oriented Recovery Enhancement
• Patient-Centered Chronic Pain Management Visits

Trial Overview The study tests the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care settings to alleviate chronic pain, enhance life quality, and minimize opioid misuse.

How Is the Trial Designed?

Group I: Mindfulness Oriented Recovery Enhancement + Patient-centered chronic pain management visits Experimental Treatment 2 Interventions

Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks, in addition to patient-centered chronic pain management visits led by their primary care provider.

Group II: Patient-centered chronic pain management visits Active Control 1 Intervention

Participants will attend patient-centered chronic pain management visits led by their primary care provider.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Published Research Related to This Trial

An 8-week Mindfulness-Based Stress Reduction (MBSR) program was found to be as effective as a multidisciplinary pain intervention (MPI) program in reducing pain intensity and pain-related distress in patients with chronic pain, based on a study of 99 participants.

Both interventions led to statistically significant improvements in pain and mood symptoms, but the overall differences between MBSR and MPI were not significant, indicating that both approaches can be beneficial for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the effectiveness of mindfulness-based stress reduction and multidisciplinary intervention programs for chronic pain: a randomized comparative trial. Wong, SY., Chan, FW., Wong, RL., et al.[2015]

The study found a predictive relationship between depression and chronic pain interference in a randomized clinical trial involving diverse, income-disadvantaged patients, highlighting the importance of addressing mental health in pain management.

Key mediators identified, such as high perceived stress, low pain self-efficacy, and poor sleep quality, suggest potential targets for improving treatment outcomes in patients suffering from both chronic pain and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression Predicts Chronic Pain Interference in Racially Diverse, Income-Disadvantaged Patients. Nephew, BC., Incollingo Rodriguez, AC., Melican, V., et al.[2022]

A systematic review of 15 randomized controlled trials involving 1,199 patients found inconclusive evidence for mindfulness skills training (MST) improving self-reported physical function in chronic pain, highlighting variability in how physical function was measured.

Strong evidence indicated that MST did not lead to improvements in physical function when assessed through performance-based measures, suggesting a need for standardized assessment methods in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. Jackson, W., Zale, EL., Berman, SJ., et al.[2023]

An interdisciplinary model for pain management was developed within an integrated health care system, focusing on improving outcomes across various care settings, including acute care and home care.

The model established four key clinical indicators to measure pain management effectiveness, emphasizing strategies like staff accountability and patient education to enhance overall care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Road to excellence in pain management: research, outcomes and direction (ROAD). Vega-Stromberg, T., Holmes, SB., Gorski, LA., et al.[2019]

The Mindfulness-Based Chronic Pain Management (MBCPM) program showed feasibility in a study with 31 veterans, leading to significant improvements in pain catastrophizing scores, indicating better coping strategies, although pain intensity itself did not significantly change.

Qualitative feedback from participants highlighted feelings of connection, increased awareness, and a sense of control, suggesting that the program may enhance overall quality of life for veterans dealing with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Mindfulness-Based Intervention for Veterans Managing Chronic Pain. Chen, SP., Liu, HT., Appelt, JC., et al.[2023]

The Mindful Recovery OUD Care Continuum (M-ROCC) program, a 24-week mindfulness-based intervention, significantly reduced comorbid pain and anxiety in patients undergoing buprenorphine treatment, as evidenced by improved scores on various psychological scales and decreased substance use.

Participants showed a notable decrease in positive urine toxicology results for cocaine and benzodiazepines, indicating that M-ROCC may help enhance retention in treatment and prevent substance misuse during opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. Schuman-Olivier, Z., Fatkin, T., Creedon, TB., et al.[2023]

A study involving surgical patients with chronic pain showed that 71% of participants used a mindfulness meditation app at least once during a 6-week period, indicating a strong interest in mindfulness-based interventions (MBIs) for pain management.

Despite the high interest, only 8% of patients adhered to the recommended usage of 10 minutes per day, highlighting the need to identify barriers to compliance in order to effectively implement non-pharmacologic pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence Patterns and Acceptability of a Perioperative, App-Based Mindfulness Meditation Among Surgical Patients With Chronic Pain. Diller, ML., Mascaro, J., Haack, C., et al.[2022]

In a study of 126 gynecologic oncology patients undergoing minimally invasive hysterectomy, higher preoperative mindfulness was linked to lower postoperative pain scores, suggesting that being more mindful can help manage pain after surgery.

While higher mindfulness was associated with lower pain levels, it did not significantly reduce opioid usage, indicating that mindfulness may improve pain perception but not necessarily decrease the need for pain medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association Between Mindfulness and Postoperative Pain: A Prospective Cohort Study of Gynecologic Oncology Patients Undergoing Minimally Invasive Hysterectomy. Weston, E., Raker, C., Huang, D., et al.[2020]

The Mindfulness-Based Chronic Pain Management course, delivered over 10 weeks, significantly improved mental health and reduced pain catastrophizing in both in-person and videoconferencing groups compared to waitlist controls, indicating its efficacy in managing chronic pain.

While both delivery methods were effective, participants receiving in-person instruction reported better physical quality of life and lower pain ratings than those attending via videoconferencing, suggesting that in-person interaction may enhance certain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating distance education of a mindfulness-based meditation programme for chronic pain management. Gardner-Nix, J., Backman, S., Barbati, J., et al.[2019]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2789279

Mindfulness-Oriented Recovery Enhancement vs ... In this study, MORE appeared to be an efficacious treatment for opioid misuse among adults with chronic pain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9476401/

Mindfulness-Oriented Recovery Enhancement for Addictive ... Mindfulness-Oriented Recovery Enhancement (MORE) is an integrative intervention designed to ameliorate addiction, chronic pain, and psychiatric symptoms.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02602535

Study Details | NCT02602535 | Mindfulness-Oriented ... The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE), an intervention designed to disrupt the risk chain.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005796722000377

Mindfulness-Oriented Recovery Enhancement reduces ... The efficacy of MORE as an integrated treatment for chronic pain and opioid-related issues is supported by multiple randomized clinical trials (RCTs) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4076008/

Mindfulness-Oriented Recovery Enhancement for Chronic ... Findings demonstrate preliminary feasibility and efficacy of MORE as a treatment for co-occurring prescription opioid misuse and chronic pain.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8886485/

Mindfulness-Oriented Recovery Enhancement vs ... In this study, MORE appeared to be an efficacious treatment for opioid misuse among adults with chronic pain.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01505101

Mindfulness-Oriented Recovery Enhancement for Chronic ... Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk of misusing prescription opioids and developing opioid addiction.

8. psychiatryonline.org psychiatryonline.org/ajp/doi/10.1176/appi.ajp.20230272

Mindfulness-Oriented Recovery Enhancement for Veterans ... This randomized clinical trial evaluated the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE) among past and present US military personnel

9. sciencedirect.com sciencedirect.com/science/article/pii/S2451865422000795

Protocol for mindfulness-oriented recovery enhancement ... An estimated 29% of chronic pain patients will misuse and 11% will abuse opiates, underscoring the need for alternative treatments for LBP patients that do not ...

10. nccih.nih.gov nccih.nih.gov/research/research-results/mindfulnessoriented-recovery-enhancement-more-may-reduce-opioid-cravings-and-chronic-pain

Mindfulness-Oriented Recovery Enhancement (MORE) May ... MORE sessions provide instruction in mindfulness techniques to increase awareness of and self-control over craving and foster nonreactivity to ...