Internet-based Treatment for Chronic Insomnia

Study Overview
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Brief Summary
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Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. This study evaluates the impact of a 6-week, online treatment for insomnia. Design This is a randomized controlled trial with online treatment and waiting list control conditions. Participants Participants are adults in Manitoba Canada with chronic insomnia. Setting Participants receive online treatment from their homes. Intervention. Online treatment consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help with medication tapering. Measurement and Results. The impact of online treatment on primary end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.

Official Title
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Evaluation of an Internet-based Treatment for Chronic Insomnia

Conditions
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Insomnia, Insomnia Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Access to high speed internet, insomnia duration > 6 months and occurring at least 4 nights per week, sleep-onset latency > 30 minutes and/or time awake at night > 30 minutes, and/or early morning awakening > 30 minutes before desired time, at least one type of daytime impairment. Exclusion Criteria: Shift work, acute suicidality, mania, schizophrenia, head injury, alcohol intake > 14 drinks/week for males, > 12 drinks per week for females, current or past behavioral treatment for insomnia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waiting list control<br> | |
| Experimental: CBT<br>A 6 weeks online course. Each week participants log on to view videos and read information that focus on a variety of intervention techniques. These include relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training. Participants also monitor their sleep using an online sleep diary and respond to questions regarding their adherence to the program. | Behavioral: Cognitive Behavioral Therapy<br>* 6 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training<br>* Other names: CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Sleep Quality was assessed by taking the average of two items: How well do you feel this morning? And How enjoyable was your sleep last night? (0 = not at all, 4 = very). | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-Sleep Arousal | Pre-sleep Arousal Scale (cognitive subscale). 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal. | 6 weeks | 
| Beliefs and Attitudes About Sleep |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, online systems