A Study to Compare the Feasibility and Effectiveness of SHUT-I vs. Standard Care for Insomnia Management in Fibromyalgia Patients

Overview

About this study

The purpose of this study is to gather preliminary data on feasibility and effectiveness of cognitive behavior therapy (SHUT-I) versus traditional sleep hygiene education on insomnia in patients with fibromyalgia.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Meets diagnostic criteria for fibromyalgia.
  • Has insomnia (ISI ≥ 15).
  • Have internet access and a device that can access the SHUTi program.
  • Willingness to participate in the clinical standard of care 7-hour fibromyalgia education program.
  • Subject has provided written informed consent to participate in the study.

Exclusion Criteria: 

  • Active sleep disorder which is not treated (obstructive sleep apnea, obesity hypoventilation syndrome).
  • Active psychiatric disorder (bipolar affective disorder, anxiety, depression, schizophrenia) which is not optimally managed.
  • Chronic fatigue syndrome.
  • Morbid obesity.
  • Subject has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ravindra Ganesh, M.B.B.S., M.D.

Open for enrollment

Contact information:

Jennifer Soderlind

(507)284-4799

Soderlind.Jennifer@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20459859

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