Web-based CBT for Insomnia Patients With Fibromyalgia

NCT ID: NCT03922867

Last Updated: 2021-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-03

Study Completion Date

2021-03-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Insomnia Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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

Group Type ACTIVE_COMPARATOR

CBT

Intervention Type BEHAVIORAL

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

Interventions

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CBT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ravindra Ganesh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ravindra Ganesh, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Sanjeev Nanda, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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18-011637

Identifier Type: -

Identifier Source: org_study_id

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