212 Participants Needed

Virtual Integrative Group Visits for Chronic Pain

TB
AC
PG
Overseen ByPaula Gardiner
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cambridge Health Alliance
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.35678

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.4591011

Research Team

PG

Paula Gardiner, MD, MPH

Principal Investigator

Cambridge Health Alliance

ZS

Zev Schuman-Olivier, MD

Principal Investigator

Cambridge Health Alliance

NH

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.
See 4 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Our Whole Lives (OWL)Experimental Treatment1 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 TrainingActive Control1 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.

Find a Clinic Near You

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.
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.
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.
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]

References

Physical functioning and mindfulness skills training in chronic pain: a systematic review. [2023]
Psychobiological correlates of improved mental health in patients with musculoskeletal pain after a mindfulness-based pain management program. [2022]
A pilot randomized control trial investigating the effect of mindfulness practice on pain tolerance, psychological well-being, and physiological activity. [2022]
Mindfulness-Based Stress Reduction: pilot study of a treatment group for patients with chronic pain in a primary care setting. [2019]
Immediate effects of a brief mindfulness-based body scan on patients with chronic pain. [2021]
Health effects of mindfulness - what should the doctor know? [2018]
Mindfulness-based randomized controlled trials led to brain structural changes: an anatomical likelihood meta-analysis. [2023]
Promising Subjective and Objective Benefits of Modified Mindfulness-Based Stress Reduction Training for Chinese Adults with Chronic Pain: A Pilot Randomized Control Study. [2023]
Integrative medical group visits for patients with chronic pain: results of a pilot single-site hybrid implementation-effectiveness feasibility study. [2023]
Depression Predicts Chronic Pain Interference in Racially Diverse, Income-Disadvantaged Patients. [2022]
Evaluating distance education of a mindfulness-based meditation programme for chronic pain management. [2019]
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