A randomized, controlled clinical trial to evaluate the efficacy of the digital Cognitive Behavioral Therapy somnio junior to reduce symptoms of insomnia in adolescens suffering from insomnia after three months of applicatio

Not Applicable

Conditions: Insomnia (F51.0/G47.0) in adolescents (14-17 years)
F51.0
G47.0
Nonorganic insomnia
Disorders of initiating and maintaining sleep [insomnias]

Registration Number: DRKS00033527

Lead Sponsor: mementor DE GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

Inclusion Criteria

?informed consent in writing of parents and participants
?diagnosis of F51.0/G47.0 / DSM-5 criteria for insomnia
?access to tablet/smartphone, which is compatible to somnio junior and access to the internet

Exclusion Criteria

?tendency to suicide
?drug abuse
?participation in other clinical trials

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the change of severity of insomnia between week 0 and week 12. The data will be collected using the subject-questionaire Insomna-Severity-Index (ISI; Dieck et al., 2018) at the timepoints t0 (week 0), t1 (week 6) and t2 (week 12).<br>An interim-analysis of (only) the data concerning the change in severity of insomnia is planned, as soon as 50% of subjects have passed t1 (week 6).

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints are the changes in sleepiness-during-day, depression, anxiety-disorder and quality-of-life. The data will be collected using subject-questionaires (sleepiness-during-day (SSS-Stanford Sleepiness Scale; Hoddes et.al., 1972); depression (PHQ-9; Kroenke et al., 2001); anxiety-disorder (GAD-7; Spitzer et al., 2006); quality-of-life (KINDL; Ravens-Sieberer, 2010)) at the timepoints t0 (week 0) and t2 (week 12).