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The Clinical Impact of Integrated Behavioral Health Techniques in Patients With Fibromyalgia

The Clinical Impact of Integrated Behavioral Health Techniques in Patients With Fibromyalgia: A Mayo Clinic-Lin Health Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06988761
Enrollment
218
Registered
2025-05-25
Start date
2025-06-09
Completion date
2026-07-30
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Brief summary

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 fibromyalgia.

Interventions

BEHAVIORALStandard of care treatment for Fibromyalgia

Patients will receive standard of care as decided by treating physician which may include patient education, physical therapy, occupational therapy, cognitive behavioral therapy, biofeedback therapy, massage, acupuncture, graded activity therapy, sleep hygiene therapy, relaxation therapies, and meditative movement therapies.

BEHAVIORALLongitudinal Behavioral Health Techniques

Patients will receive standard of care as decided by treating physician, along with the integration of longitudinal behavioral health techniques provided by Lin Health. Patients have 24/7 access to digital content and will be able to interact directly with care team members on average three times per week.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient must be 18 years of age or older. * Patient must have a diagnosis of Fibromyalgia. * 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 * Patient must be willing and able to complete all aspects of the study. * Patient must be able to speak and read English.

Exclusion criteria

* Patient who is under the age of 18 years old. * Patient who is unable to provide informed consent or HIPAA authorization. * Patient who declines study participation. * Patient who is unable to speak English. * Patient who is on active cancer therapy. * Patient who is actively psychotic or actively suicidal. * Patient who is deemed inappropriate to the study by the medical professional.

Design outcomes

Primary

MeasureTime frameDescription
Fibromyalgia Impact Questionnaire - RevisedBaseline, 3 monthsThe Revised Fibromyalgia Impact Questionnaire (FIQR) is a self-report questionnaire designed to assess the impact of fibromyalgia on a patient's daily life. It evaluates function, overall impact, and symptoms experienced in the past 7 days. The FIQR uses an 11-point numeric scale (0 to 10) for each of the 21 questions, with higher scores indicating a greater impact of fibromyalgia.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORElizabeth C. Wight, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026