Mindfulness + Pain Management Visits for Chronic Pain

Recruiting at 2 trial locations

Overseen By Taylor Scott, 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

Trial Summary

What is the purpose of this trial?

The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy.

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.

What data supports the effectiveness of the treatment Mindfulness-Oriented Recovery Enhancement and Patient-Centered Chronic Pain Management Visits for chronic pain?

Research shows that mindfulness-based programs can improve mental health and quality of life for people with chronic pain. For example, a study found that veterans participating in a mindfulness-based program reported feeling more aware and in control, and their negative thoughts about pain decreased. ^{1 2 3 4 5}

Is mindfulness-based pain management safe for humans?

Research on mindfulness-based interventions for chronic pain suggests they are generally safe for humans. Participants in studies have reported enjoying the interventions and experiencing improvements in mental health and stress levels, with no significant safety concerns noted. ^{2 6 7 8 9}

How is the Mindfulness-Oriented Recovery Enhancement treatment different from other treatments for chronic pain?

Mindfulness-Oriented Recovery Enhancement (MORE) is unique because it combines mindfulness practices with techniques to help patients develop positive beliefs and regain motivation and pleasure, which can reduce the need for opioids and improve well-being. This integrative approach is different from traditional treatments that often rely heavily on medication. ^{1 10 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating distance education of a mindfulness-based meditation programme for chronic pain management. [2019]

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

Road to excellence in pain management: research, outcomes and direction (ROAD). [2019]

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

Utilizing an outcomes approach to improve pain management by nurses: a pilot study. [2019]

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

Feasibility of Mindfulness-Based Intervention for Veterans Managing Chronic Pain. [2023]

6. England 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. [2023]

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

Adherence Patterns and Acceptability of a Perioperative, App-Based Mindfulness Meditation Among Surgical Patients With Chronic Pain. [2022]

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

The Association Between Mindfulness and Postoperative Pain: A Prospective Cohort Study of Gynecologic Oncology Patients Undergoing Minimally Invasive Hysterectomy. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Long-lasting improvements in health-related quality of life among women with chronic pain, following multidisciplinary rehabilitation. [2019]

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

Does mindfulness improve outcomes in patients with chronic pain? Systematic review and meta-analysis. [2022]

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

Comparing the effectiveness of mindfulness-based stress reduction and multidisciplinary intervention programs for chronic pain: a randomized comparative trial. [2015]

12. Switzerland pubmed.ncbi.nlm.nih.gov

[Mindfulness-Oriented Recovery Enhancement (MORE): integrative treatment for chronic pain]. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Depression Predicts Chronic Pain Interference in Racially Diverse, Income-Disadvantaged Patients. [2022]