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Using web-based CBT-I to improve sleep to prevent depression and anxiety in adolescents at high risk: a randomized controlled trial protocol

Spiropoulos A, Vincent N, Tomfohr-Madsen L, Brost A, Schmidtler H, MacKinnon AL, Kopala-Sibley DC

Trials, 2026

50 participants

Abstract

Background: Among adolescents, internalizing disorders are a leading cause of the global burden of disability and death due to suicide. There is a critical need to prevent first-lifetime onsets of internalizing disorders, particularly among high-risk adolescents. Insomnia and poor sleep have been robustly linked to internalizing disorders in adolescents. The present trial will examine if brief, web-based Cognitive Behavioral Therapy for Insomnia (CBT-I) reduces insomnia symptoms, improves sleep quality, and improves subthreshold internalizing symptoms in never-clinically depressed or anxious adolescents with sleep problems (insomnia severity scores indicating subthreshold insomnia or higher) who are at risk for internalizing disorders due to a parental history of these disorders.

Methods: This trial uses a two-arm, single-blinded, parallel group randomized controlled design (N = 50). Participants in the treatment group will complete a web-based CBT-I intervention (return2sleep) that is comprised of 7 sessions (six adolescent sessions and one parent session). Participants in the control group will receive a psychoeducational pamphlet and be encouraged to continue treatment (if any) as usual. Insomnia severity, sleep quality, and depressive and anxiety symptoms will be assessed at three time points (baseline, immediately post-treatment, and three months post-treatment). Additionally, clinically significant internalizing disorders in adolescents will be assessed using…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.

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