i-Sleep: Internet-based Treatment for Insomnia

Study Overview
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Brief Summary
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In this study, people who suffer from insomnia will be randomized to one of three study conditions. The first group receives a multicomponent internet-based cognitive behavioral self-help intervention. The second group has access to an internet-based self-help sleep restriction intervention. The third group is a waiting control group. In both active conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of a multicomponent internet-based cognitive behavioral self-help intervention as well as a stand-alone internet-based self-help sleep restriction intervention for insomnia symptoms compared to a waiting list. Assessments take place at baseline, and 8-weeks and 6-months post-randomization. After 8 weeks, participants in the waiting control group get access to the internet-based cognitive behavioural self-help intervention and also fill out questionnaires at 6-months post-randomization.

Official Title
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i-Sleep: Internet-based Treatment for Insomnia. A Randomized Controlled Trial

Conditions
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Insomnia

Intervention / Treatment
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* Other: Multicomponent internet-based self-help
* Other: Internet-based sleep restriction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being 18 years of age or older Meet ICSD-3 diagnostic criteria for Insomnia as confirmed by the telephone administered Interview Acess to the Internet Written informed consent Exclusion Criteria: Physiological Insomnia Serious psychiatric co-morbidity that requires alternative treatment including major depression disorder, anxiety disorder, substance dependence, bipolar affective disorder, psychotic illness Epilepsy (seizure 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multicomponent internet-based self-help<br>Multicomponent internet-based self-help | Other: Multicomponent internet-based self-help<br>* Internet-based self-help on the basis of (Perlis, M. L., Jungquist, C., Smith, M. T., & Posner, D., 2006). The self-help program consists of eight text-based sessions and tasks. All participants in the active conditions receive guidance during 8-weeks treatment.<br>|
| Experimental: Internet-based sleep restriction<br>Internet-based sleep restriction | Other: Internet-based sleep restriction<br>* Internet-based self-help on the basis of (Perlis, M. L., Jungquist, C., Smith, M. T., & Posner, D., 2006). The self-help program consists of five text-based sessions and tasks. All participants in the active conditions receive guidance during 8-weeks treatment.<br>|
| No Intervention: Waiting control group<br>Access to internet-based intervention after 8-weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) |  | Baseline | 
| Insomnia Severity Index (ISI) |  | 8-weeks | 
| Insomnia Severity Index (ISI) |  | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of Insomnia | International Classification of Insomnia Disorders (ICSD-3) | Baseline, 8-weeks, 6-months | 
| Sleep-diary: Sleep efficiency (SE) |  | 8-weeks | 
| Sleep-Diary-data |  | 8-weeks | 
| Dysfunctional Beliefs and Attitudes about Sleep 16 (DBAS-16) |  | Baseline, 8-weeks, 6-months | 
| Patient satisfaction (ZUF-8) |  | 8-weeks | 
| Empowerment Scale (ES) |  | Baseline, 8-weeks, 6-months | 
| EuroQol |  | Baseline, 8-weeks, 6-months | 
| Usability: Satisfaction with the online program (SUS) |  | 8-weeks | 
| Pittsburgh Sleep Quality Index (PSQI) |  | Baseline, 8-weeks, 6-months |