A Study to Compare the Feasibility and Effectiveness of SHUT-I vs. Standard Care for Insomnia Management in Fibromyalgia Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-011637
NCT ID: NCT03922867
Sponsor Protocol Number: 18-011637
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Ivana Croghan, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available