Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia

Study Overview
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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..

Official Title
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Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia in Patients Prescribed Insomnia Medications

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Internet cognitive behavioral therapy for insomnia (iCBTI)
* Behavioral: Class in sleeping well and improving insomnia


Participation Criteria
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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. Exclusion Criteria: Contained in inclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCBTI<br>Intervention: An internet-based cognitive behavioral therapy program for insomnia (iCBTI) that is tailored to the individual's needs based on responses to questions. | Behavioral: Internet cognitive behavioral therapy for insomnia (iCBTI)<br>* An internet-based program for providing individually tailored CBTI based on participant responses to questions and performance on weekly guided sleep strategies.<br>|
| Active Comparator: Usual care<br>Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center. | Behavioral: Class in sleeping well and improving insomnia<br>* A group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days supply of dispensed insomnia medications | Days supply of dispensed insomnia medications up to one year after randomization. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care inpatient and outpatient encounters | Number of physician or mid-level provider encounters (face-to-face, telephone, video): (1) outpatient, (2) acute care: emergency, inpatient, up to one year after randomization. | One year |