Mindfulness Meditation for Fibromyalgia

Overseen By Roland Staud, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Analgesics, Hypnotics, Anxiolytics, Antidepressants

Disqualifiers: Photosensitive epilepsy, Cancer, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 2 hours

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Breathing Attention Training (BAT), a type of mindfulness meditation, might reduce the pain and symptoms of fibromyalgia, a condition causing widespread pain and sensitivity. Participants will practice either focused breathing and mindfulness or just deep breathing to determine which method better manages pain. Individuals with fibromyalgia for more than six months who are willing to pause their current pain medications might be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore new pain management techniques for fibromyalgia.

Will I have to stop taking my current medications?

Yes, you will need to stop taking pain relievers, sleep aids, anxiety medications, or antidepressants for at least 5 half-lives (a period based on how long it takes for the drug to reduce to half its amount in the body) before and during the study.

What prior data suggests that Breathing Attention Training is safe for fibromyalgia patients?

Research on mindfulness meditation for fibromyalgia shows that it is generally safe. No negative safety issues have emerged. Studies also demonstrate that mindfulness training can reduce anxiety and depression, often associated with fibromyalgia. This suggests that Breathing and Attention Training (BAT), a type of mindfulness meditation, is well-tolerated. Overall, evidence indicates that BAT is a safe option for those with fibromyalgia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Breathing and Attention Training (BAT) for fibromyalgia because it introduces a mindfulness-based approach that focuses on enhancing body awareness and stress management. Unlike standard treatments like medications and physical therapy, BAT emphasizes deep breathing and attention training, helping participants become more attuned to their body sensations and mindful breathing. This technique could offer a drug-free alternative, potentially reducing reliance on medications and improving quality of life. Additionally, the Controlled Deep Breathing comparator highlights relaxation benefits, aiming to provide insights into how different breathing techniques can uniquely impact fibromyalgia symptoms.

What evidence suggests that Breathing Attention Training is effective for fibromyalgia?

Research shows that Breathing and Attention Training (BAT), a treatment in this trial, can reduce symptoms in people with fibromyalgia. Studies have found that mindfulness techniques, included in BAT, improve quality of life and lessen depression in fibromyalgia patients. Evidence suggests that mindfulness-based stress reduction boosts well-being for those with fibromyalgia. Although more research is needed to understand its exact effect on pain sensitivity, early findings indicate that BAT may help the brain manage chronic pain better. Overall, mindfulness methods like BAT appear promising in easing the discomfort associated with fibromyalgia. ^{1 2 4 6 7}

Who Is on the Research Team?

Roland Staud, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults with fibromyalgia, a condition causing widespread pain, who've had symptoms for over 6 months and meet specific diagnostic criteria. Healthy individuals without chronic pain can also join as controls. Participants must stop taking certain medications like painkillers and antidepressants before the study.

Inclusion Criteria

I am healthy, of similar age, and do not suffer from chronic pain.

I have been diagnosed with fibromyalgia and have had pain for more than 6 months.

Exclusion Criteria

Prior history of cancer or diabetes

I am willing to stop taking my pain, sleep, anxiety, or depression meds for the study.

I or someone in my family has epilepsy triggered by lights.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Breathing and Attention Training (BAT) or Controlled Deep Breathing for 20 minutes

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain modulation and sensory stimuli ratings

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Breathing and Attention Training (BAT)
• Breathing Control

Trial Overview

The study tests Breathing and Attention Training (BAT), a type of mindfulness meditation that may reduce fibromyalgia symptoms and sensitivity to pain. It's compared against standard breathing control techniques using quantitative sensory testing to measure effects on pain modulation.

How Is the Trial Designed?

Group I: Breathing and Attention Training (BAT) Experimental Treatment 1 Intervention

Participants will be asked to do 20-minutes of focused breathing and attention training, involving focusing on taking deep breaths and becoming aware of the changing body sensations associated with breathing (mindfulness).

Group II: Controlled Deep Breathing Active Control 1 Intervention

Participants will be asked to do 20-minutes of deep breathing and letting the body relax.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

The study found that an 8-week second-generation mindfulness-based intervention (SG-MBI) called meditation awareness training (MAT) significantly improved symptoms of fibromyalgia syndrome (FMS), including pain perception and sleep quality, in 74 participants compared to a control group.

Improvements in FMS symptoms were linked to reduced attachment to self and increased civic engagement, suggesting that these psychological factors play a crucial role in the effectiveness of SG-MBIs for treating FMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial. Van Gordon, W., Shonin, E., Dunn, TJ., et al.[2022]

Mindfulness meditation shows potential in managing mood-related symptoms such as anxiety and depression, as well as sleep-related issues in individuals with fibromyalgia, based on a review of seven studies.

While the evidence is not strong enough to recommend mindfulness for all fibromyalgia symptoms, improvements in coping and perceived stress suggest it could be a valuable complementary approach, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness as a Symptom Management Strategy for Fibromyalgia: An Integrative Review. Gordon, S., Brown, R., Hogan, M., et al.[2023]

A study involving 4,986 adults with fibromyalgia found that higher levels of mindfulness, as measured by the Five Facet Mindfulness Questionnaire (FFMQ), were associated with less severe fibromyalgia symptoms, suggesting that mindfulness techniques may help alleviate symptoms.

The research highlighted that the 'observe' aspect of mindfulness was notably high among participants, indicating a potential area for further investigation to understand its impact on fibromyalgia and mindfulness assessments in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibromyalgia Impact and Mindfulness Characteristics in 4986 People with Fibromyalgia. Jones, KD., Mist, SD., Casselberry, MA., et al.[2018]

In a pilot study involving 41 fibromyalgia patients, mindfulness plus amygdala and insula retraining (MAIR) showed significant improvements in functional impairment, anxiety, and depression compared to relaxation therapy, indicating its efficacy as an adjunct treatment.

MAIR also led to a notable reduction in brain-derived neurotrophic factor (BDNF) levels, suggesting a potential mechanism of action, although it did not affect immune-inflammatory markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial. Sanabria-Mazo, JP., Montero-Marin, J., Feliu-Soler, A., et al.[2020]

In a pilot study with 40 fibromyalgia patients, cognitive behavioral therapy (CBT) for insomnia significantly improved alertness, executive functioning, and sleep quality compared to a sleep hygiene program.

The improvements in executive functioning were linked to better sleep, suggesting that CBT for insomnia can positively impact both sleep disturbances and cognitive performance in fibromyalgia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for insomnia improves attentional function in fibromyalgia syndrome: a pilot, randomized controlled trial. Miró, E., Lupiáñez, J., Martínez, MP., et al.[2018]

The Spanish version of the Mindful Attention Awareness Scale (MAAS) demonstrated strong psychometric properties in a study of 251 fibromyalgia patients, confirming its two-factor structure and high internal consistency (Cronbach's α = 0.90).

MAAS scores were low in this sample, indicating a potential area for improvement in mindfulness among fibromyalgia patients, and the scale showed good test-retest reliability (ICC = 0.90), suggesting it is a reliable tool for measuring mindfulness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric properties of the Spanish version of the Mindful Attention Awareness Scale (MAAS) in patients with fibromyalgia. Cebolla, A., Luciano, JV., DeMarzo, MP., et al.[2021]

Nonpharmacologic treatment strategies for fibromyalgia show promise, with no negative outcomes reported in the reviewed studies, suggesting these approaches can be safe and beneficial.

Long-term participation in exercise and behavioral strategies, such as progressive muscle relaxation, is crucial for maintaining improvements in symptoms and quality of life, highlighting the importance of ongoing support from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic management strategies in fibromyalgia. Burckhardt, CS.[2019]

Mindfulness-based stress reduction (MBSR) significantly improved functional impairment in fibromyalgia patients compared to treatment-as-usual (TAU) and showed large effect sizes immediately after treatment and medium to large effects at a 12-month follow-up.

MBSR was also more effective than a multicomponent intervention (FibroQoL) post-treatment, with improvements in pain catastrophizing and overall fibromyalgia symptoms, indicating that mindfulness practices can play a crucial role in managing fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled efficacy trial of mindfulness-based stress reduction compared with an active control group and usual care for fibromyalgia: the EUDAIMON study. Pérez-Aranda, A., Feliu-Soler, A., Montero-Marín, J., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5693231/

Mindfulness Meditation for Fibromyalgia: Mechanistic and ...

MBSR has been shown to be equally effective compared to other behavioral interventions (CBT; health education) in treating a wide spectrum of chronic pain- ...

2.

withpower.com

withpower.com/trial/phase-fibromyalgia-2-2023-bb8a6

Mindfulness Meditation for Fibromyalgia

Research suggests that mindfulness techniques, which are part of BAT, can improve quality of life and reduce depressive symptoms in people with fibromyalgia.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04304664

Mindfulness- Based Intervention for Fibromyalgia Patients

Various studies have shown a significant interaction between specific patient characteristics and treatment outcome. In this study, the investigators will ...

4.

painphysicianjournal.com

painphysicianjournal.com/current/pdf?article=NzkxMA%3D%3D&journal=166

Mindfulness Meditation for Fibromyalgia Syndrome

Background: The effectiveness of mindfulness meditation (MM) for the treatment of fibromyalgia syndrome (FMS) is unknown and needs to be updated. Objective: ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1744388124000331

Mindfulness-based stress reduction (MBSR) for ...

According to a growing body of evidence, MBSR may improve FM patients' well-being. Overall, studies that have examined MBSR on FM patients pointed to its ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04304664

Mindfulness- Based Intervention for Fibromyalgia Patients

Various studies have shown a significant interaction between specific patient characteristics and treatment outcome. In this study, the investigators will ...

7.

academic.oup.com

academic.oup.com/painmedicine/article/25/12/703/7726135

Mind-body therapy for treating fibromyalgia: a systematic review

With the exception of mindfulness-based stress reduction, all therapies had at least 1 study showing significant improvements in pain at the end of treatment.