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Life sciences · Interventional Study
ClinicalTrials.gov · October 8, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07865728). This is a study registration, not published results. Lead sponsor: Universidad Pública de Navarra. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 250 participants (ESTIMATED). Conditions: Sleep Disturbance, Sleep Problems, Substance Use (Drugs, Alcohol), Anxiety, Depression. Interventions: BEHAVIORAL: Transdiagnostic Intervention for Sleep and Circadian Dysfunction; BEHAVIORAL: Healthy habits psychoeducation. Primary outcome measures: Change from baseline in Sleep Quality assessed by the Brief Pittsburgh Sleep Quality Index (B-PSQI) Global Score and its dimensions. , Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention. Brief summary: This cluster randomized controlled trial will evaluate whether a brief, school-based group adaptation of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) improves sleep and mental health in adolescents aged 14 to 17 years. Public secondary schools in Navarre (Spain) will be randomly assigned, stratified by urban/rural location, to deliver either TranS-C or an attention-matched healthy-habits psychoeducation program. Both programs consist of four weekly 45-minute group sessions delivered during school hours by trained psychologists. The main questions it aims to answer are: Does TranS-C improve sleep quality and daytime sleepiness compared with the control program? Does TranS-C reduce anxiety-depressive symptoms, psychotic-like symptoms, interpersonal difficulties and substance use compared with the control program? Participants will complete self-report questionnaires at baseline, after the intervention, and 3, 6 and 9 months after the intervention.