A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a handheld computer is superior to a self-help manual for the treatment of chronic primary insomnia.

Detailed Description
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Chronic primary insomnia is a highly prevalent condition, affecting up to 15% of the population. The condition is associated with daytime fatigue, lack of concentration, and decreased quality of life. Most people with chronic primary insomnia go untreated, because of a desire to avoid medication or lack of access to quality non-drug treatments. Therefore, an affordable, easy to use, and effective computer to help assess and treat insomnia symptoms could bring treatment to this population. Comparison: We are comparing a new handheld computer that uses cognitive-behavioral treatment principles to a popular self-help manual for the treatment of primary insomnia symptoms.

Official Title
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Computerized Self-Help Treatment for Primary Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Computerized delivery of cognitive-behavioral treatment of insomnia
* Behavioral: Self-help manual to improve insomnia symptoms


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sleep less than 6.5 hours per night at least 30 minutes of sleep onset latency or wakefulness after sleep onset symptoms present for at least 6 months must have insomnia symptoms at least 3 days per week Exclusion Criteria: Body Mass Index greater than 32 Presence of anxiety disorder Secondary forms of insomnia Presence of a substance use disorder Concurrent treatment for another mental disorder History of other sleep disorders, including: apnea, restless legs, periodic limb movement disorder, or narcolepsy

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Computerized delivery of cognitive-behavioral treatment of insomnia|nan|
|Behavioral: Self-help manual to improve insomnia symptoms|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sleep parameters via polysomnography |  |  | 
| Changes in sleep parameters via self-reported sleep diary |  |  | 
| Changes in symptom severity as measured by Insomnia Severity Index |  |  | 
| Changes in symptom severity as measured by Pittsburgh Sleep Quality Index |  |  | 
| Changes in symptom severity as measured by the Multi-dimensional Fatigue Inventory |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in depression symptoms as measured by Beck Depression Inventory II |  |  | 
| Changes in quality of life as measured by a qualitative instrument |  |  | 
| Usability of the device as measured by a qualitative questionnaire |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Sleep