Virtual Integrative Group Visits for Chronic Pain

Overseen By Paula Gardiner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cambridge Health Alliance

Disqualifiers: Severe depression, Mania, Psychosis, others

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

Compensation: Varies

Number of Visits: 10

212 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this research study is to test the efficacy of a non-prescription medicine, web-based platform solution for patients with chronic pain, to improve pain self-management and related outcomes. The main question investigators aim to answer is; would the use of this web-based intervention plus an online group visit compared to control result in better pain-related outcomes and improved pain impact?

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

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

What data supports the effectiveness of this treatment for chronic pain?

Research shows that mindfulness-based treatments, like Mindfulness-Based Stress Reduction (MBSR), can help reduce pain-related distress and improve mental health in people with chronic pain. These treatments focus on improving mindfulness skills, which can lead to better pain management and psychological well-being. ^{1 2 3 4 5}

Is mindfulness-based training safe for humans?

Mindfulness-based training, which includes practices like Mindfulness-Based Stress Reduction (MBSR), is generally considered safe for humans and has been shown to help with chronic pain, anxiety, and depression without significant safety concerns. ^{3 5 6 7 8}

How is the Virtual Integrative Group Visits for Chronic Pain treatment different from other treatments for chronic pain?

This treatment is unique because it combines mindfulness training with group medical visits and integrative medicine, offering a non-drug approach that includes peer support and mind-body techniques, which can be particularly beneficial for underserved populations with limited access to traditional therapies. ^{4 5 9 10 11}

Research Team

Paula Gardiner, MD, MPH

Principal Investigator

Cambridge Health Alliance

Zev Schuman-Olivier, MD

Principal Investigator

Cambridge Health Alliance

Niina Haas, PHD

Principal Investigator

BrightOutcome

Eligibility Criteria

This trial is for individuals experiencing chronic pain. Participants should be comfortable using web-based platforms and engaging in online group sessions. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions to join.

Inclusion Criteria

I have had chronic pain in my muscles or bones for over 3 months, with pain most days.

I am over 18 years old.

Exclusion Criteria

I am not experiencing mania or psychosis.

Active heroin or cocaine use in the past 3 months

I do not have any serious health or personal issues that would stop me from joining the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Recruitment Screening Call

Informed Consent and Baseline

Participants complete informed consent and baseline survey session

1 week

Informed Consent Session, Baseline Survey Session

Intervention

Participants engage with the Our Whole Lives (OWL) e-health platform and participate in live-online mindfulness group weekly for 9 weeks

9 weeks

Weekly online sessions

Control

Participants engage with low dose content on the OWL platform without group engagement

9 weeks

Follow-up

Participants complete follow-up survey sessions to assess outcomes

14 weeks

Follow-Up Survey Sessions at Week 10, Week 16, and Week 24

Optional Interview

Participants may participate in an optional individual interview or focus group

Treatment Details

Interventions

• Low Dose Mindfulness Training
• Our Whole Lives (OWL)

Trial Overview The study tests a non-prescription, web-based program called Our Whole Lives (OWL) combined with Low Dose Mindfulness Training against a control group to see if it improves self-management of chronic pain and its impact on daily life.

Participant Groups

Group I: Our Whole Lives (OWL) Experimental Treatment 1 Intervention

Our Whole Lives (OWL) is a 9-week online curriculum on the GEMINI platform. OWL is a nine-session, web-accessible, self-paced mindfulness curriculum that has interactive components of self-monitoring and social support (online community).

Group II: Low Dose Mindfulness Training Active Control 1 Intervention

The GEMINI platform will facilitate the delivery of a low-dose mindfulness version of Our Whole Lives program. Participants will interface with the GEMINI platform's static content.

Who Is Running the Clinical Trial?

Cambridge Health Alliance

Lead Sponsor

Trials

65

Recruited

22,400+

BrightOutcome

Industry Sponsor

Trials

7

Recruited

610+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

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]

In a study of 28 patients with chronic pain, an 8-week mindfulness-based pain management program (MBPM) improved mental health and perceived control over pain, but did not significantly reduce clinical or experimental pain ratings.

The improvements in mental health were linked to increased brain activity in areas responsible for cognitive control and emotional regulation during pain anticipation, suggesting that better emotional regulation may enhance the perception of control over pain rather than directly reducing pain intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychobiological correlates of improved mental health in patients with musculoskeletal pain after a mindfulness-based pain management program. Brown, CA., Jones, AK.[2022]

Mindfulness training significantly increased pain tolerance in 42 university students compared to a control group that received guided visual imagery, indicating its potential as an effective intervention for managing pain.

While mindfulness skills showed a strong trend of improvement in the mindfulness group, this increase was not directly linked to the enhanced pain tolerance, suggesting that other mechanisms may be at play.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized control trial investigating the effect of mindfulness practice on pain tolerance, psychological well-being, and physiological activity. Kingston, J., Chadwick, P., Meron, D., et al.[2022]

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]

A 10-minute mindfulness-based body scan significantly reduced pain-related distress and the impact of pain on social relations in a clinical setting among 55 adults with chronic pain, compared to a control group.

While the body scan showed immediate benefits in the clinic, these effects were not observed in participants' normal environments, indicating that the setting may influence the effectiveness of brief mindfulness interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate effects of a brief mindfulness-based body scan on patients with chronic pain. Ussher, M., Spatz, A., Copland, C., et al.[2021]

Mindfulness practices have been shown to effectively reduce chronic pain, anxiety, and depression symptoms, while also enhancing immune function, indicating its broad therapeutic potential.

There is a dose-response relationship where more mindfulness practice leads to greater reductions in stress and mood symptoms, along with beneficial changes in brain structure and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health effects of mindfulness - what should the doctor know? Raevuori, A.[2018]

A meta-analysis of 11 studies involving 581 participants found that mindfulness-based interventions lead to significant structural brain changes, particularly in the right insula and precentral gyrus, which are linked to improved attention and pain modulation.

These findings suggest that mindfulness practices can enhance neural plasticity, supporting their long-term benefits for mental processes and pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based randomized controlled trials led to brain structural changes: an anatomical likelihood meta-analysis. Siew, S., Yu, J.[2023]

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]

The Integrative Medical Group Visit (IMGV) approach for chronic pain management was found to be feasible and acceptable, with 12 out of 16 enrolled patients completing at least two sessions, highlighting its potential as a non-pharmacological intervention.

While no statistically significant improvements were observed in most health outcome measures, qualitative feedback indicated that participants gained valuable self-care skills and social support, suggesting that IMGV may enhance coping strategies for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative medical group visits for patients with chronic pain: results of a pilot single-site hybrid implementation-effectiveness feasibility study. Roth, I., Tiedt, M., Miller, V., et al.[2023]

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]

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]

References

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

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

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

Psychobiological correlates of improved mental health in patients with musculoskeletal pain after a mindfulness-based pain management program. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A pilot randomized control trial investigating the effect of mindfulness practice on pain tolerance, psychological well-being, and physiological activity. [2022]

4. 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]

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

Immediate effects of a brief mindfulness-based body scan on patients with chronic pain. [2021]

6. Finland pubmed.ncbi.nlm.nih.gov

Health effects of mindfulness - what should the doctor know? [2018]

7. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based randomized controlled trials led to brain structural changes: an anatomical likelihood meta-analysis. [2023]

8. 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]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Integrative medical group visits for patients with chronic pain: results of a pilot single-site hybrid implementation-effectiveness feasibility study. [2023]

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

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

11. England pubmed.ncbi.nlm.nih.gov

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