Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia

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

136630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-13

Study Completion Date

2019-06-19

Brief Summary

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The investigators will conduct a randomized, controlled trial of internet-based cognitive behavioral therapy (iCBT) vs usual care for insomnia. The target population is patients prescribed medications for insomnia who have not had a dispensation of these medications in the preceding six months. The primary outcomes is dispensed days supply over the subsequent one year. Secondary outcomes include all types of health system clinical encounters. The investigators hypothesize that the group randomized into iCBT will have less insomnia medications dispensed than usual care controls, and less clinical encounters..

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Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iCBTI

Intervention: An internet-based cognitive behavioral therapy program for insomnia (iCBTI) that is tailored to the individual's needs based on responses to questions.

Group Type EXPERIMENTAL

Internet cognitive behavioral therapy for insomnia (iCBTI)

Intervention Type BEHAVIORAL

An internet-based program for providing individually tailored CBTI based on participant responses to questions and performance on weekly guided sleep strategies.

Usual care

Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center.

Group Type ACTIVE_COMPARATOR

Class in sleeping well and improving insomnia

Intervention Type BEHAVIORAL

A group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia.

Interventions

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Internet cognitive behavioral therapy for insomnia (iCBTI)

An internet-based program for providing individually tailored CBTI based on participant responses to questions and performance on weekly guided sleep strategies.

Intervention Type BEHAVIORAL

Class in sleeping well and improving insomnia

A group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* A prescription for any of a set of selected insomnia medications.
* Age \>18 years at the time of the prescription.
* A recent (\<30 days before the prescription date) diagnosis of insomnia as determined by a set of selected International Classification of Disease (ICD) codes, to be used for medications that are not prescribed just for insomnia.
* Membership for \>365 days prior to the prescription date.
* No evidence of a dispensed insomnia medication within six months (183 days) of the current prescription.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No