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

NCT ID: NCT06988761

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-09
• Study Completion Date: 2025-12-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

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

Group Type: EXPERIMENTAL

Longitudinal Behavioral Health Techniques

Intervention Type: 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.

Control Group

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

Group Type: ACTIVE_COMPARATOR

Standard of care treatment for Fibromyalgia

Intervention Type: 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.

Interventions

Standard 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.

Intervention Type: BEHAVIORAL

Longitudinal 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth C. Wight

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth C. Wight, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

25-000227

Identifier Type: -

Identifier Source: org_study_id