Internet Delivered Self-Help CBT for Insomnia

Study Overview
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Brief Summary
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The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.

Official Title
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Phase 3 Study of Internet-based Self-help for Insomnia: Factors That Are Associated With Success of the Intervention

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insomnia Access to the internet Exclusion Criteria: Alcohol or substance abuse Being suicidal Sleep apnea Schizophrenic or having a psychosis disorder

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet Deliviered CBT for Insomnia<br>Cognitive behavioral self-help method for insomnia via the Internet | Behavioral: Cognitive Behavioral Treatment<br>* The techniques used throughout the self-help manual are all effective in reducing insomnia: 1) Stimulus control: patients should only go to bed when sleepy, use the bed and bedroom for sleep (and sex) only, maintain a regular rising time, avoid daytime naps and get out of bed and go into another room when unable to fall asleep within 15-20 minutes (return only when sleepy). 2) progressive muscle relaxation. 3) sleep hygiene education (improving health and environmental factors that affect sleep). 3). Sleep restriction, whereby participants will stay only the time in bed that they sleep. 4) cognitive therapy to challenge and dispute incorrect and unhelpful thoughts about sleep (e.g. I must sleep at least 8 hours, otherwise I'll be a wreck tomorrow).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep diary | Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings. | baseline | 
| Sleep diary | Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings. | 4-week follow-up | 
| Sleep diary | Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings. | 18-week follow-up | 
| Sleep diary | Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings. | 48-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Measured with the HADS | Baseline | 
| Anxiety | HADS | 4-week follow-up | 
| Anxiety | HADS | 18-week follow-up | 
| Anxiety | HADS | 48-week follow-up | 
| Depression | CES-D | Baseline | 
| Depression | CES-D | 4 week follow-up | 
| Depression | CES-D | 18-week follow-up | 
| Depression | CES-D | 48-week follow-up | 
| Sleep medication | Sleep medication as measured by the sleep diary | Baseline | 
| Sleep medication | Sleep medication as measured by the sleep diary | 4-week follow-up | 
| Sleep medication | Sleep medication as measured by the sleep diary | 18-week follow-up | 
| Sleep medication | Sleep medication as measured by the sleep diary | 48-week follow-up | 
| Insomnia Severity | Insomnia Severity Index | Baseline | 
| Insomnia severity | Insomnia Severity Index | four-week follow-up | 
| Insomnia severity | Insomnia Severity Index | 18-week follow-up | 
| Insomnia severity | Insomnia Severity Index | 48-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Intervention, Self-help, Internet