Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth

Study Overview
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Brief Summary
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Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is a prevalent and costly problem. This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants in the Telehealth condition will report significantly greater improvements in sleep parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity, and daytime fatigue than those in the Internet condition and that b)participants in the Telehealth condition will show better adherence to treatment and greater satisfaction with treatment than those in the Internet condition.

Official Title
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Delivery of Cognitive-Behavioral Treatment for Insomnia Via Telehealth or Internet

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be residents of rural Manitoba (Canada) Must meet research diagnostic criteria for insomnia Must have access to a computer and high-speed internet Exclusion Criteria: Comorbid conditions (medical and psychiatric) must be stable

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Telehealth<br>Complete CBT group via telehealth | Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)<br>* 6-week course of CBT delivered either using internet or telehealth<br>|
| Experimental: Internet<br>Complete Internet-based CBT program | Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)<br>* 6-week course of CBT delivered either using internet or telehealth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity | The primary outcome measure will be insomnia severity, as assessed by the Insomnia Severity Index (ISI; Morin, 2003), a 6-item self-report measure of impairment due to sleep difficulties | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep diary data | Sleep diaries are a standard daily outcome measure for insomnia. The version used here (Morin, 1993) includes information regarding total sleep time, sleep-onset latency, sleep-efficiency, number of night awakenings, time awake in then night, sleep quality, and frequency of use of sleep medications. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Cognitive-Behavioral Therapy, Internet, Telehealth