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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a web-based platform can help people manage chronic pain better without medication. It tests two versions of an online mindfulness program: one with more engagement and support, and the other with basic content. The trial seeks English-speaking adults who have experienced chronic musculoskeletal pain (pain in muscles and bones) for at least three months and have had pain on most days in the past six months. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques without medication.

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 prior data suggests that this web-based platform solution is safe for patients with chronic pain?

Research has shown that mindfulness-based programs, such as the Our Whole Lives (OWL) program, are generally safe. Studies have found that these programs can reduce pain and improve mental health without causing significant harm.

Mindfulness practices, central to both the OWL program and Low Dose Mindfulness Training, are well-tolerated by most individuals. They aim to reduce stress and support mental well-being. Reports of negative effects from these practices are rare.

Overall, both the OWL program and Low Dose Mindfulness Training have been used in other studies without major safety concerns. These treatments offer a non-drug way to manage chronic pain and can be a safe option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Integrative Group Visits for Chronic Pain trial because it explores innovative ways to manage chronic pain using mindfulness. Unlike traditional treatments like medication and physical therapy, the "Our Whole Lives" (OWL) program offers a unique 9-week, self-paced, online curriculum that combines mindfulness training with social support through an interactive online community. The Low Dose Mindfulness Training offers a more accessible version of this program, allowing participants to engage with static content on the GEMINI platform. This approach could provide an alternative for individuals seeking non-pharmacological, flexible pain management options.

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

Research has shown that the "Our Whole Lives" (OWL) program, one treatment in this trial, can help people manage chronic pain more effectively. One study found that participants using the OWL program felt more confident in handling their pain, with a 13% decrease in opioid use among those in the program. Meanwhile, low-dose mindfulness training, another treatment arm in this trial, has reduced pain and symptoms of depression, while also helping people manage their pain better. Both treatments in this trial aim to empower individuals to take control of their chronic pain using mindfulness and community support. ^{1 3 6 7 8}

Who Is on the Research Team?

Zev Schuman-Olivier, MD

Principal Investigator

Cambridge Health Alliance

Paula Gardiner, MD, MPH

Principal Investigator

Cambridge Health Alliance

Niina Haas, PHD

Principal Investigator

BrightOutcome

Are You a Good Fit for This Trial?

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.

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

Active heroin or cocaine use in the past 3 months

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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 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]

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]

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]

Citations

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Integrative medical group visits for patients with chronic pain Integrative Medical Group Visit (IMGV) offers an innovative approach to chronic pain management through training in mindfulness, nutrition, and other mind-body ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06515925

Our Whole Lives Gemini: Virtual Integrative Medical Group ... 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, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6919581/

Effectiveness of integrative medicine group visits in chronic ... Comparing the effectiveness of mindfulness-based stress reduction and multidisciplinary intervention programs for chronic pain: a randomized comparative trial.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0225540

Effectiveness of integrative medicine group visits in chronic ... Data collected at baseline, 9, and 21 weeks included primary outcomes depressive symptoms (Patient Health Questionnaire 9), pain (Brief Pain ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714416301628

Design of the integrative medical group visits randomized ... Our primary outcomes are reductions in chronic pain and depressive symptoms, increased pain self-efficacy and reduced self-reported pain medication use. In this ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04340739?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22BrightOutcome%22)&viewType=Table&rank=6

Group intEgrative MINdfulness Over the Internet Using an ... This is a one-year study designed to improve upon the latest version of an education website for adult chronic pain patients called Our Whole Lives for ...

7. withpower.com withpower.com/trial/phase-chronic-pain-7-2024-30379

Virtual Integrative Group Visits for Chronic Pain Mindfulness-based training, which includes practices like Mindfulness-Based Stress Reduction (MBSR), is generally considered safe for humans and has been shown ...

8. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2023.1147588/full

Integrative medical group visits for patients with chronic pain IMGV offers an innovative approach to chronic pain management through training in mindfulness, nutrition, and other mind-body techniques combined with peer ...