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

Trial Summary

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 data supports the effectiveness of the treatment Breathing and Attention Training (BAT) 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. Additionally, non-drug strategies like mindfulness have shown promise in managing fibromyalgia symptoms and improving daily functioning. ^{1 2 3 4 5}

Is mindfulness meditation safe for humans?

Research on mindfulness meditation for fibromyalgia shows no negative safety outcomes, suggesting it is generally safe for humans. ^{2 3 4 6 7}

How does the treatment Breathing and Attention Training (BAT) differ from other treatments for fibromyalgia?

Breathing and Attention Training (BAT), also known as Mindfulness Meditation, is unique because it focuses on improving symptoms like anxiety, depression, and sleep issues through mindfulness techniques, which involve being present and aware in the moment. Unlike traditional medications, BAT is a non-drug approach that emphasizes mental and emotional well-being, potentially increasing self-compassion and psychological flexibility. ^{1 3 4 6 8}

What is the purpose of this trial?

The hypersensitivity of fibromyalgia is associated with abnormal pain modulation within the CNS, but not with peripheral or central sensitization. Many brain areas that contribute to modulation of pain are known, but their testing is complex and expensive. Quantitative sensory testing is easier to perform and repeatable. Therefore, it will be used to evaluate the effects of Breathing Attention Training (BAT) on the hypersensitivity of FM participants. BAT is a form of mindfulness meditation shown to decrease FM symptoms and possibly pain sensitivity. We hypothesize that pain modulation of chronic pain patients is improved by BAT.

Research Team

Roland Staud, MD

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Fibromyalgia Impact and Mindfulness Characteristics in 4986 People with Fibromyalgia. [2018]

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

Nonpharmacologic management strategies in fibromyalgia. [2019]

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

Psychometric properties of the Spanish version of the Mindful Attention Awareness Scale (MAAS) in patients with fibromyalgia. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial. [2022]

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

Cognitive-behavioral therapy for insomnia improves attentional function in fibromyalgia syndrome: a pilot, randomized controlled trial. [2018]

6. United States 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. [2021]

7. Switzerland 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. [2020]

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

Mindfulness as a Symptom Management Strategy for Fibromyalgia: An Integrative Review. [2023]