Mindfulness Meditation for Fibromyalgia

Recruiting in Palo Alto (17 mi)

Overseen by Roland Staud, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Florida

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

Disqualifiers: Photosensitive epilepsy, Cancer, Diabetes, others

No Placebo Group

Trial Summary

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.

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}

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.

Trial 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) (Behavioural Intervention)
• Breathing Control (Behavioural Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Florida Gainesville, FL

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1428

Patients Recruited

987,000+

Findings from Research

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]

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]