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NCT07865728
Transdiagnostic Sleep Intervention to Improve Mental Health in Adolescents
Conditions: Sleep Disturbance, Sleep Problems, Substance Use (Drugs, Alcohol), Anxiety, Depression
Sex: All
Ages: 13 Years – 17 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 250
Sponsor: Universidad Pública de Navarra
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.
Eligibility Criteria
Inclusion Criteria:
* Aged 14 to 17 years
* Enrolled in compulsory secondary education (ESO), upper secondary (Bachillerato) or vocational training (FP) in a participating public school in Navarre, Spain
* Written informed consent from the participant and their legal guardian(s)
* Valid self-report responses (≥75% correct answers)
Exclusion Criteria:
* Comprehension difficulties that prevent participation (e.g., language disorders)
* Severe physical or mental health problems that prevent participation in the program
* Currently receiving pharmacological or psychological treatment for sleep problems
Source: ClinicalTrials.gov (NCT07865728). StuddyBuddy aggregates publicly available trial information.