Behavioral Health Techniques for Fibromyalgia

Overseen By Department of Medicine

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Active cancer, Psychosis, Suicidal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a virtual care program called Lin Health can assist in managing fibromyalgia, a condition characterized by widespread pain and fatigue. It compares two groups: one receiving both usual care from the Mayo Clinic and Lin Health interventions, and the other receiving only usual care. This trial suits adults diagnosed with fibromyalgia who are already receiving treatment at the Mayo Clinic in Rochester, MN, and can participate in English. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance fibromyalgia management.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these behavioral health techniques are safe for fibromyalgia patients?

Research has shown that Lin Health provides a safe way to help people with fibromyalgia. Lin Health uses an online program to manage symptoms and reduce pain. Studies have found that these behavioral techniques are usually easy for people to handle. No major reports of negative side effects from Lin Health have emerged, suggesting it is safe for most people with fibromyalgia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Lin Health for fibromyalgia because it integrates behavioral health techniques with Mayo Clinic's standard care. Unlike traditional treatments that focus primarily on medication and physical therapy, Lin Health emphasizes a holistic approach, combining psychological support and lifestyle modifications. This method targets the mind-body connection, which could potentially enhance pain management and improve overall quality of life for those with fibromyalgia. By offering a more comprehensive approach, Lin Health may address underlying issues that typical treatments might overlook.

What evidence suggests that Lin Health is effective for fibromyalgia?

Research has shown that Lin Health, which participants in this trial may receive as part of the experimental group, may help reduce fibromyalgia symptoms. A 2023 study found that using Lin Health led to a 45% decrease in pain intensity, comparable to the best treatments available. Lin Health also improves overall quality of life, pain levels, and sleep for people with fibromyalgia. These findings suggest that Lin Health could effectively manage fibromyalgia symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Elizabeth C. Wight, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with fibromyalgia, a condition characterized by widespread musculoskeletal pain. Participants should be seeking or currently receiving standard care for fibromyalgia and willing to engage in virtual follow-up care.

Inclusion Criteria

I am willing and able to follow all study requirements.

Patient must be being seen at the Mayo Clinic Fibromyalgia and Chronic Fatigue Clinic in Rochester, MN

Patient must be able to understand and provide informed consent and HIPAA authorization

Exclusion Criteria

Patient who is unable to speak English

I am currently receiving treatment for cancer.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mayo Clinic's usual standard of care and Lin Health interventions

3 months

Virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Long-term

Virtual long-term follow-up care

What Are the Treatments Tested in This Trial?

Interventions

• Lin Health

Trial Overview The study is examining the effectiveness of Lin Health's virtual long-term follow-up care, which includes integrated behavioral health techniques, compared to the standard treatment for fibromyalgia.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

Subjects in the experimental group will receive Mayo Clinic's usual standard of care and Lin Health interventions.

Group II: Control Group Active Control 1 Intervention

Subjects in control group will receive Mayo Clinic's usual standard of care.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. lin.health lin.health/conditions/fibromyalgia

Fibromyalgia Management, Causes & Treatment It is worth noting that EAET has been found to be particularly effective in reducing fibromyalgia symptoms. These therapies reduce sensitization of the nervous ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07201818

Study Details | NCT07201818 | LET for Fibromyalgia The purpose of this research study is to determine the effectiveness of Lymphatic Enhancement Technology (LET) treatment in patients with ...

3. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/fibromyalgia

Fibromyalgia Clinical Trials The purpose of this study is to assess the feasibility of implementing a virtual longitudinal behavioral health regimen (via Lin Health) in patients with ...

4. cdn.prod.website-files.com cdn.prod.website-files.com/614b2ca6137715b5a98a9d6a/64884d081123f1d99744f937_LHMG%20Whitepaper%20June%202023-min.pdf

2023 Report Findings: Lin's results are on par with the IMPACT study gold standard for pain recovery outcomes. 45%reduction in pain intensity. It's no wonder that people with chronic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11908403/

Evolution of the Quality of Life of Long-Term Fibromyalgia ... The significant improvements in QoL, pain intensity, and sleep quality, maintained over time, underscore the MMW device's ability to provide ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06988761

The Clinical Impact of Integrated Behavioral Health ... The purpose of this research is to assess the impact of using Lin Health to provide virtual long-term follow up care for patients with a diagnosis of ...

7. mayo.edu mayo.edu/research/clinical-trials/cls-20569965

Behavioral Health Techniques with Fibromyalgia The purpose of this study is to assess the feasibility of implementing a virtual longitudinal behavioral health regimen (via Lin Health) in patients with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7735791/

Efficacy and Safety of ASP0819 in Patients with Fibromyalgia ASP0819 was also found to be safe and tolerable as indicated by Phase 1 testing in healthy volunteers. Presented here are the results from a ...

9. lin.health lin.health/lp1/fibromyalgia1

Find relief from fibromyalgia pain Lin's program offers a behavioral approach to help people with fibromyalgia manage symptoms and reduce pain.

10. link.springer.com link.springer.com/article/10.1007/s10865-023-00429-3

Self-guided digital acceptance and commitment therapy for ... The study population was 98.5% female, with an average age of 53 years and an average baseline FM symptom severity score of 8 out of 11.