Insomnia
Conditions
Brief summary
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.
Interventions
OTHERMulticomponent internet-based self-help
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.
OTHERInternet-based sleep restriction
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.
Sponsors
Insel Gruppe AG, University Hospital Bern
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI) | Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | Baseline, 8-weeks, 6-months | — |
| Diagnosis of Insomnia | Baseline, 8-weeks, 6-months | International Classification of Insomnia Disorders (ICSD-3) |
| Sleep-diary: Sleep efficiency (SE) | 8-weeks | — |
| Sleep-Diary-data | 8-weeks | — |
| Usability: Satisfaction with the online program (SUS) | 8-weeks | — |
| Patient satisfaction (ZUF-8) | 8-weeks | — |
| Empowerment Scale (ES) | Baseline, 8-weeks, 6-months | — |
| EuroQol | Baseline, 8-weeks, 6-months | — |
| Dysfunctional Beliefs and Attitudes about Sleep 16 (DBAS-16) | Baseline, 8-weeks, 6-months | — |
Countries
Switzerland
Outcome results
None listed