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

NCT06988761 | Active Not Recruiting

• 1 other identifier: 25-000227
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia Impact Questionnaire - Revised

  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.

  Baseline, 3 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Behavioral: Longitudinal Behavioral Health Techniques

Control Group

ACTIVE COMPARATOR

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

Behavioral: Standard of care treatment for Fibromyalgia

Interventions

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.

Control Group

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Elizabeth C. Wight, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: June 9, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)