Web-based CBT for Insomnia Patients With Fibromyalgia

Mayo Clinic

Status: Completed

Conditions: Fibromyalgia; Insomnia

Treatments: Behavioral: CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT03922867

18-011637

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Control Group

No Intervention group

Description:

Subjects with receive standard of care for management of insomnia in subjects with fibromyalgia

Intervention Group

Active Comparator group

Description:

Subjects will receive standard of care and additionally complete the online cognitive behavior therapy program

Treatment:

Behavioral: CBT