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practicality reasons; recruitment slower than expected
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| Name | Class |
|---|---|
| Insel Gruppe AG, University Hospital Bern | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicomponent internet-based self-help | Experimental | Multicomponent internet-based self-help |
|
| Internet-based sleep restriction | Experimental | Internet-based sleep restriction |
|
| Waiting control group | No Intervention | Access to internet-based intervention after 8-weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent internet-based self-help | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | Baseline | |
| Insomnia Severity Index (ISI) | 8-weeks | |
| Insomnia Severity Index (ISI) | 6-months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Berger, PhD | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bern | Bern | 3012 | Switzerland |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| Internet-based sleep restriction | Other | 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. |
|
| 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 |
| D001523 |
| Mental Disorders |