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

Mayo Clinic

Status: Not yet enrolling

Conditions: Fibromyalgia

Treatments: Behavioral: Standard of care treatment for Fibromyalgia; Behavioral: Longitudinal Behavioral Health Techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT06988761

25-000227

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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

Treatment:

Behavioral: Longitudinal Behavioral Health Techniques

Control Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard of care treatment for Fibromyalgia