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

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard of care treatment for Fibromyalgia

Behavioral

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.

Longitudinal Behavioral Health Techniques

Behavioral

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.

Primary outcomes

Fibromyalgia Impact Questionnaire - Revised

Time frame: Baseline, 3 months

The 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 25, 2025
Registry last updated: Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed