G47.0 F51.0
Conditions
Interventions
Group 1: Participants in the intervention group receive direct access to the online therapy program HelloBetter Schlafen. The program consists of 8 units and aims to reduce insomnia symptoms. Insomnia
Sponsors
GET.ON Institut für Online Gesundheitstrainings GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Clinically relevant insomnia symptoms (ISI =15), Diagnosis, Sufficient knowledge of German, Sufficient computer and internet skills, Internet access
Exclusion criteria
Exclusion criteria: Substantial suicide risk measured at baseline by item 9 of the BDI II (score >1), psychotic disorder, epilepsy, bipolar disorder, sleep disorder other than insomnia, current use of a digital health application targeted at insomnia, ISI < 15
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia complaints as measured by the German version of the Insomnia Severity Index (ISI) 10 weeks after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| - Depressive symptoms (German version of the Patient Health Questionnaire-9; PHQ-9); baseline, post (10 weeks); 6-months-follow-up - Anxiety (German version of the Generalised Anxiety Disorder Scale-7; GAD-7), baseline, post (10 weeks), 6-months-follow-up - Health-related quality of life (German version of the 36-Item Short Form Survey; SF-36) baseline, post (10 weeks), 6-months-follow-up - Sleep-related cognitions (German version of the Dysfunctional Beliefs and Attitudes about Sleep Scale; DBAS) baseline, post (10 weeks), 6-months-follow-up - Somatic symptoms (German version of the Somatic Symptom Scale; SSS-8) baseline, post (10 weeks), 6-months-follow-up - Sleep parameters: Self-reported time in bed, sleep time, sleep interruptions, sleep onset latency, sleep efficiency, influences on sleep; baseline, post (10 weeks), 6-months-follow-up - Daytime well-being: Self-report (range 1-10) regarding general mood, fatigue, and performance during the day, number and duration of naps; baseline, post (10 weeks), 6-months-follow-up) - Substance use: (sleep) medications (self-report), questions on alcohol and caffeine consumption (self-report); baseline, post (10 weeks), 6-months-follow-up - Sleep quality (German version of the Pittsburgh Sleep Quality- Index; PSQI); baseline, post (10 weeks), 6-months-follow-up - Fatigue (German version of the Chalder Fatigue Scale, FS); baseline, post (10 weeks), 6-months-follow-up - Subjective global impression of change by patients (German version of the Patient Global Impression Scale; PGI); baseline (only PGI-S), post (10 weeks), 6-months-follow-up - General psychological symptoms (German version of the Brief Symptom Inventory; BSI); baseline, post (10 weeks), 6-months-folllow-up - Global impression of change by an independent clinician (German version of the Clinical Global Impression Scale; CGI); baseline, post (10 weeks); clinical interview - Depressive symptoms (German version of the Hamilton Depression Rating Scale; H | — |
Countries
Germany
Outcome results
None listed