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 application

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 application - Somnio Junior

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033527

Enrollment

Registered

2024-07-25

Start date

2025-01-30

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia (F51.0/G47.0) in adolescents (14-17 years) F51.0 G47.0

Interventions

Group 1: Arm 1 is the digital intervention "somnio junior" and TAU (Treatment-As-Usual (aka SOC, Standard-Of-Care)). The question to be answered is, if the 12-weeks application of the digital interven

Eligibility

Sex/Gender

All

Age

14 Years to 17 Years

Inclusion criteria

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

Exclusion criteria: ? tendency to suicide ? drug abuse ? participation in other clinical trials

Design outcomes

Primary

Measure	Time frame
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). 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).	—

Measure

Time frame

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). 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).

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Germany

Contacts

Public ContactAlexander Prehn-Kristensen

Institut für Kinder- und Jugendpsychiatrie

Alexander.Prehn-Kristensen@uksh.de0431 500 98316

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026