Mindfulness + Placebo for Chronic Pain

(MAPP Trial)

Recruiting at 1 trial location

Overseen By Chung Jung Mun, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Vitamin B2

Disqualifiers: Acute pain, Malignant pain, Psychopathology, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

45 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop using vitamin B2 supplements or multivitamins containing vitamin B2 during the study.

What data supports the effectiveness of the treatment MBSR+OLP for chronic pain?

Mindfulness-Based Stress Reduction (MBSR) has been shown to help reduce pain and improve quality of life for people with chronic pain, such as chronic low back pain. It is recognized as a first-line non-drug treatment by the American College of Physicians. ^{1 2 3 4 5}

Is Mindfulness-Based Stress Reduction (MBSR) safe for humans?

Mindfulness-Based Stress Reduction (MBSR) is generally considered safe for humans and is recommended as a non-drug treatment for chronic pain, such as low back pain, by the American College of Physicians. ^{1 2 4 5 6}

How is the MBSR+OLP treatment for chronic pain different from other treatments?

The MBSR+OLP treatment is unique because it combines mindfulness-based stress reduction (a structured meditation practice) with an open-label placebo (a placebo given with full transparency), offering a non-drug approach that may improve pain management and quality of life without the side effects associated with medications. ^{1 2 7 8 9}

What is the purpose of this trial?

This study proposes a three-arm randomized-controlled trial (RCT) that evaluates the feasibility and acceptability of combining a mindfulness-based therapy (MBT) and open-label placebo (OLP) treatment for individuals with chronic pain. Individuals with chronic pain will be recruited to participate in an 8-week trial, with a subsequent 3-month post-treatment follow-up. Participants will be randomly assigned to one of the following three conditions: 1. Mindfulness-Based Stress Reduction (MBSR) 2. OLP treatment 3. combination of MBSR and OLP treatment

Research Team

Chung Jung Mun, Ph.D.

Principal Investigator

Arizona State University

Eligibility Criteria

The MAPP study is for individuals experiencing chronic pain. Participants will be involved in an 8-week trial with a follow-up after 3 months. To join, they must meet certain conditions but the provided information does not specify what these are.

Inclusion Criteria

Ability to speak, write, and read in English

I have experienced pain on most days in the last 3 months.

My average pain level last week was 3 or higher on a scale of 0 to 10.

Exclusion Criteria

Currently pregnant or breastfeeding

I am currently experiencing pain from a recent injury or surgery.

I have long-term pain from cancer or HIV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Mindfulness-Based Stress Reduction (MBSR), open-label placebo (OLP) treatment, or a combination of both for chronic pain management

8 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Assessments at baseline, mid-treatment, post-treatment, and 3-month follow-up

Treatment Details

Interventions

• MBSR+OLP
• Mindfulness-Based Stress Reduction (MBSR)
• Open-Label Placebo (OLP)

Trial Overview This trial examines three approaches to managing chronic pain: Mindfulness-Based Stress Reduction (MBSR), Open-Label Placebo (OLP), and a combination of both MBSR and OLP. Participants will be randomly placed into one of these groups.

Participant Groups

Group I: OLP-Only Experimental Treatment 1 Intervention

This experimental arm receives the OLP treatment only.

Group II: MBSR-Only Experimental Treatment 1 Intervention

This experimental arm receives the 8-week MBSR program only.

Group III: MBSR+OLP Experimental Treatment 1 Intervention

This experimental arm receives the 8-week MBSR program AND the 8-week OLP treatment.

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

In a feasibility trial involving 60 patients with migraine headaches, Mindfulness-Based Stress Reduction (MBSR) was successfully implemented, with 68% of participants adhering to the intervention by attending at least 5 out of 8 classes.

Key factors for successful recruitment and retention included close monitoring of recruitment activities, flexibility in protocol modifications, and integration within the healthcare delivery system, highlighting the importance of these strategies for future MBSR trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment, retention, and adherence in a randomized feasibility trial of mindfulness-based stress reduction for patients with migraine. Law, H., Avins, A., Stahl, R., et al.[2021]

Mindfulness-based stress reduction (MBSR) techniques significantly improve subjective pain scores and quality of life in chronic pain patients, particularly those with chronic low back pain, based on a review of 12 empirical studies.

Despite some limitations such as small sample sizes and varied pain measurement tools, the evidence suggests that MBSR can be an effective non-pharmacological treatment option for managing chronic pain and enhancing mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Mindfulness Practices for Improving Outcomes in Chronic Low Back Pain. Smith, SL., Langen, WH.[2022]

A culturally adapted mindfulness-based stress reduction (MBSR) program significantly reduced pain catastrophizing in Chinese adults with chronic pain, showing a moderate effect immediately after treatment, although this effect did not persist at the 3-month follow-up.

The MBSR group also demonstrated improvements in pain interference and perceived stress compared to the control group, along with unique changes in brain activity as indicated by fMRI, suggesting potential neurobiological benefits from the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promising Subjective and Objective Benefits of Modified Mindfulness-Based Stress Reduction Training for Chinese Adults with Chronic Pain: A Pilot Randomized Control Study. Chen, S., Gao, X., Shi, T., et al.[2023]

A survey of 118 primary care providers (PCPs) revealed that 70.1% were familiar with Mindfulness-Based Stress Reduction (MBSR), and 59.0% referred patients to MBSR at least once a year, indicating a significant awareness and utilization of this non-pharmacological treatment for chronic low back pain.

Collaboration between PCPs and mindfulness instructors was limited, with only 16.3% of referring PCPs reporting such collaboration, suggesting a need for improved communication and education to enhance patient access to MBSR programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Interprofessional Collaboration and Referral to Mindfulness-Based Stress Reduction Programs. Binda, DD., Weinberg, JM., Nguyen, T., et al.[2023]

An eight-week Mindfulness-Based Stress Reduction (MBSR) program showed significant improvements in pain disability, psychological distress, and activity levels among 17 adult patients with chronic pain.

Participants reported a greater willingness to experience pain and lower subjective ratings of current pain, indicating that MBSR can be an effective intervention for managing chronic pain symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction: pilot study of a treatment group for patients with chronic pain in a primary care setting. Beaulac, J., Bailly, M.[2019]

Mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) both show clinically significant benefits in improving physical functioning and reducing pain intensity in patients with chronic pain, based on a review of 21 studies involving over 1,900 participants.

There was no significant difference in effectiveness between MBSR and CBT, suggesting that both therapies are viable options for managing chronic pain, but further research is needed to standardize measures and guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioural therapy for the treatment and management of chronic pain: A systematic review and network meta-analysis. Khoo, EL., Small, R., Cheng, W., et al.[2023]

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]

A systematic review of three randomized controlled trials involving 117 patients with chronic low back pain found that mindfulness-based stress reduction (MBSR) showed significant short-term improvements in pain intensity and disability for patients with failed back surgery syndrome, but not for older adults with chronic low back pain.

Overall, the evidence for MBSR's effectiveness in improving pain intensity or disability in chronic low back pain is inconclusive, although there is some indication that it may help improve pain acceptance. Further research with larger sample sizes and better control conditions is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for low back pain. A systematic review. Cramer, H., Haller, H., Lauche, R., et al.[2021]

An 8-week mindfulness-based stress reduction (MBSR) program significantly improved pain intensity and health-related quality of life (HRQoL) in chronic pain patients, particularly those with arthritis, who showed the largest treatment effects.

The effectiveness of MBSR varied by chronic pain condition, with patients experiencing chronic headaches or fibromyalgia showing the least improvement, highlighting the importance of individual differences in treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for chronic pain conditions: variation in treatment outcomes and role of home meditation practice. Rosenzweig, S., Greeson, JM., Reibel, DK., et al.[2022]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Recruitment, retention, and adherence in a randomized feasibility trial of mindfulness-based stress reduction for patients with migraine. [2021]

2. India pubmed.ncbi.nlm.nih.gov

A Systematic Review of Mindfulness Practices for Improving Outcomes in Chronic Low Back Pain. [2022]

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

Promising Subjective and Objective Benefits of Modified Mindfulness-Based Stress Reduction Training for Chinese Adults with Chronic Pain: A Pilot Randomized Control Study. [2023]

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

Characterizing Interprofessional Collaboration and Referral to Mindfulness-Based Stress Reduction Programs. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction: pilot study of a treatment group for patients with chronic pain in a primary care setting. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioural therapy for the treatment and management of chronic pain: A systematic review and network meta-analysis. [2023]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for low back pain. A systematic review. [2021]

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

Mindfulness-based stress reduction for chronic pain conditions: variation in treatment outcomes and role of home meditation practice. [2022]