Digital CBT-I for Adolescent Insomnia: Randomized Controlled Trial Protocol

DRKS00033527 is a monocentric randomized controlled trial protocol comparing digital cognitive behavioral therapy for insomnia to sleep hygiene advice in adolescents. The study aims to recruit 66 participants aged 14–17 in Germany, with outcomes measured at baseline, 6 weeks, and 12 weeks post-randomization. The protocol document is authored by Beke Ralfs and shared under a CC-BY-4.0 license.

Use Cases

• Analyzing trial design and methodology for digital health interventions based on the described randomized controlled trial structure.
• Comparing primary and secondary endpoints for insomnia treatment efficacy based on the Insomnia Severity Index and measures of depression, anxiety, and quality of life.
• Studying recruitment and data collection protocols for adolescent clinical trials based on the described participant criteria and assessment schedule.

Strengths

• The protocol is clearly defined with a primary endpoint (Insomnia Severity Index) and multiple secondary endpoints.
• The study design includes a specific sample size (66 participants) and age range (14–17 years).
• The document is openly licensed (CC-BY-4.0) and includes a clinical trial registration identifier (DRKS00033527).

Limitations

• The dataset is a PDF protocol document; the underlying clinical trial data is not included.
• Row count and column-level documentation for any eventual data are unknown.
• Description metadata is limited; actual data quality requires manual inspection after download.

Provenance

Source

Beke Ralfs

Collection Method

Described as a prospective randomized controlled trial.

Freshness

Last updated 2026-05-01 05:28:17; freshness should be verified.

Geography

Germany