Web-based CBT for Insomnia Patients With Fibromyalgia

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT03922867

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Insomnia Fibromyalgia	Behavioral: CBT	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 3, 2019

Actual Primary Completion Date :

Feb 28, 2021

Actual Study Completion Date :

Mar 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group Subjects with receive standard of care for management of insomnia in subjects with fibromyalgia
Active Comparator: Intervention Group Subjects will receive standard of care and additionally complete the online cognitive behavior therapy program	Behavioral: CBT A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia

Arm

Intervention/Treatment

No Intervention: Control Group

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

Active Comparator: Intervention Group

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

Behavioral: CBT

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

Outcome Measures

Primary Outcome Measures

Change in insomnia severity [through study completion, an average of 12 weeks]
Surveying the changes in insomnia severity seen during the subjects participation in the study
Change in attitude towards sleep [through study completion, an average of 12 weeks]
Surveying the subjects attitude towards sleep over the duration of their participation in the study.

Secondary Outcome Measures

Change in fibromyalgia symptoms [through study completion, an average of 12 weeks]
Surveying the change in fibromyalgia symptoms that occur during study participation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Ravindra Ganesh, MBBS, MD, Mayo Clinic
Study Chair: Sanjeev Nanda, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Ravindra Ganesh, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03922867

Other Study ID Numbers:

18-011637

First Posted:

Apr 22, 2019

Last Update Posted:

Mar 5, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ravindra Ganesh, Principal Investigator, Mayo Clinic

insomnia

fibromyalgia

Additional relevant MeSH terms:

Fibromyalgia

Myofascial Pain Syndromes

Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Mar 5, 2021