Skip to content

Web-based CBT for Insomnia Patients With Fibromyalgia

Comparison of Feasibility and Efficacy of a Web-based Cognitive Behavioral Therapy Versus Usual Care for Management of Insomnia in Patients With Fibromyalgia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03922867
Enrollment
18
Registered
2019-04-22
Start date
2019-12-03
Completion date
2021-03-03
Last updated
2021-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, Insomnia

Keywords

insomnia, fibromyalgia

Brief summary

Researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms.

Detailed description

The investigators are studying the effect of an internet-based cognitive behavioral therapy for insomnia, compared with usual care in fibromyalgia patients. Fibromyalgia patients will consent to study, and a determination made if the patients meet criteria. If eligible, qualifying patients will be randomized, and begin participation in randomized intervention. During participation on the study subjects will complete surveys at set intervals.

Interventions

BEHAVIORALCBT

A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Meets diagnostic criteria for fibromyalgia * Has insomnia * Have internet access and a device that can access the web-based program.

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

Design outcomes

Primary

MeasureTime frameDescription
Change in insomnia severitythrough study completion, an average of 12 weeksSurveying the changes in insomnia severity seen during the subjects participation in the study
Change in attitude towards sleepthrough study completion, an average of 12 weeksSurveying the subjects attitude towards sleep over the duration of their participation in the study.

Secondary

MeasureTime frameDescription
Change in fibromyalgia symptomsthrough study completion, an average of 12 weeksSurveying the change in fibromyalgia symptoms that occur during study participation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026