Digital treatment for insomnia in adolescents: study protocol for a randomized controlled trial comparing digital cognitive behavioral therapy for insomnia to sleep hygiene.

Abstract

Background: Insomnia is highly prevalent among adolescents. It is associated with various mental and physical disorders and impairments in daytime functioning. Cognitive behavioral therapy for insomnia (CBT-I) is well supported by evidence and the guideline recommended treatment. Yet only few adolescents receive access due to limited health care resources. Digital delivery of CBT-I may tackle this care gap and has shown promising results in the adult population. However, evidence in the adolescent population is still preliminary. The aim of this randomized controlled trial is to establish whether digitally delivered CBT-I for insomnia is effective in adolescents, when compared to sleep hygiene advice.

Methods: This trial is a monocentric, national, prospective randomized controlled trial aiming to recruit 66 adolescent participants (14-17 years) meeting criteria for insomnia disorder in Germany. Participants will be randomized (1:1) to either 12 weeks of digital CBT-I (somnio junior) or sleep hygiene advice. Outcomes will be collected at baseline, 6- and 12-weeks post-randomization. The primary endpoint is self-reported insomnia severity using the Insomnia Severity Index at 12 weeks. Secondary endpoints include symptoms of depression, anxiety, daytime sleepiness and health-related quality of life. Analyzes will be intention-to-treat.

Discussion: The results of this study could make the case for the introduction of digital CBT-I for adolescents in primary care in Germany, increasing access to evidence-based treatment for adolescents with insomnia disorder. Treating insomnia might also positively affect associated mental disorders and physical health problems.

Clinical trial registration: https://www.bfarm.de/DE/Das-BfArM/Aufgaben/Deutsches-Register-Klinischer-Studien/_node.html, identifier DRKS00033527.