Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet

Study Overview
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Brief Summary
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Background: Insomnia is a highly prevalent and disabling disorder where Cognitive Behavior Therapy for Insomnia (CBT-I) is established as the best available treatment. Still, only a negligible number of patients with insomnia receive this treatment. One potential way of improving the dissemination of CBT-I is by using online adaptations of CBT-I. This is a new method for delivering CBT-I and it is not known how effective online treatment is compared to face-to-face CBT-I. This trial's purpose is to compare face-to-face CBT-I with online CBT-I. Because of the great advantage of online treatment in both availability and cost, the trial is designed as a noninferiority trial. Aim: To test if online CBT-I is noninferior in reducing insomnia complaints compared with CBT-I as delivered face-to-face by a therapist.

Official Title
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Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Noninferiority Trial

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Internet CBT-i SHUTi
* Behavioral: face-to-face CBT-i


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria for insomnia disorder Exclusion Criteria: a condition that renders the patient incapable of understanding the treatment (e.g. actively psychotic, mental retardation, dementia or others an ongoing substance abuse problem other organic sleep disturbances or circadian sleep disturbance an ongoing medical condition where treatment of insomnia is not indicated (e.g. an attack phase of multiple sclerosis) working night shifts and being unable to discontinue this work pattern not being sufficiently fluent in Norwegian to understand the assessments or treatment not having the necessary computer skills needed to log on to the web based program

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Internet CBT-i<br>Participants will be instructed on the use of the internet CBT-i (SHUTi) intervention site, then use the program for six weeks. | Behavioral: Internet CBT-i SHUTi<br>* Computer program SHUTi is based on the same theoretical model of insomnia and involves the same interventions as ordinary CBT-I: a structured treatment focusing on education, behaviors and cognitions. Specifically, CBT-I usually consists of one or more of the following: psychoeducation about sleep, sleep restriction therapy, stimulus control, relaxation techniques, and challenging beliefs and perception of sleep.<br>|
| Active Comparator: face-to-face CBT-i<br>4 to 8 sessions of face-to-face CBT-i treatment with one of three clinicians (experienced CBT-i psychiatrists) | Behavioral: face-to-face CBT-i<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insomnia severity | as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8) | 6 months | 
| insomnia severity | as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internet, Cognitive therapy, Behavior therapy, Waiting lists, Therapy, computer-assisted