Transdiagnostic Sleep Intervention to Improve Mental Health in Adolescents
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorUniversidad Pública de Navarra
About this trial
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
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transdiagnostic Intervention for Sleep and Circadian Dysfunction
BehavioralIt combines cognitive-behavioral techniques, sleep medicine principles and circadian regulation strategies to establish regular sleep-wake schedules and modify dysfunctional sleep-related beliefs and behaviors. It consists of four weekly 45-minute sessions delivered in school hours by trained psychologists.
Healthy habits psychoeducation
BehavioralAttention-control program covering healthy nutrition, physical activity, and hygiene habits. It consists of four weekly 45-minute group sessions delivered in school hours by trained psychologists.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Transdiagnostic Intervention for Sleep and Circadian DysfunctionExperimental treatment 1 intervention
Group B: Healthy habits psychoeducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in Sleep Quality assessed by the Brief Pittsburgh Sleep Quality Index (B-PSQI) Global Score and its dimensions.
Sleep quality over the past month is measured with the 6-item adolescent Spanish version of the B-PSQI. It assesses sleep duration, sleep latency, night awakenings, sleep efficiency, sleep schedule and subjective sleep quality. The global score ranges from 0 to 15, with higher scores indicating worse sleep quality.
Time frame
Baseline, post-intervention (week 4), and 3, 6 and 9 months post-interventionSecondary outcomes
1
Change from baseline in Depressive Symptoms as Assessed by the SA-45 Depression Subscale Score and the DASS subscale for depression
The SA-45 is a 45-item short form of the Symptom Checklist-90. Items are rated from 0 (not at all) to 4 (very much) for the past week. The depression subscale has 5 items, and its score ranges from 0 to 20. Higher scores indicate more severe symptoms. The DASS-21 depression subscale has 7 items assessing symptoms over the past week. Each item is rated from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). The subscale score is the sum of the items multiplied by 2, giving a range from 0 to 42. Higher scores indicate more severe depressive symptoms.
Time frame
Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention2
Change From Baseline in Anxiety Symptoms as Assessed by the SA-45 Anxiety Subscale Score and the Depression Anxiety Stress Scales-21 (DASS-21) Anxiety Subscale Score
The SA-45 is a 45-item short form of the Symptom Checklist-90. Items are rated from 0 (not at all) to 4 (very much) for the past week. The Anxiety subscale has 5 items, and its score ranges from 0 to 20. Higher scores indicate more severe symptoms. The DASS-21 Anxiety subscale has 7 items assessing symptoms over the past week. Each item is rated from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). The subscale score is the sum of the items multiplied by 2, giving a range from 0 to 42. Higher scores indicate more severe anxiety symptoms.
Time frame
Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention3
Change From Baseline in Number of Standard Drinks Consumed in the Past 30 Days as Assessed by the Timeline Follow-Back (TLFB). And Number of Participants Reporting Drug Use as Assessed by the Drug Use History Questionnaire (DUHQ)
The TLFB is a retrospective calendar method for recording daily alcohol consumption over the past 30 days. One standard drink unit equals 10 g of alcohol. Higher values indicate greater alcohol use. The DUHQ, adapted for adolescents, assesses use of 11 substance classes. This outcome is the number of different substance classes used in the past year, ranging from 0 to 11. Higher values indicate more substances used.
Time frame
Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention4
Change From Baseline in Impulsivity as Assessed by the Barratt Impulsiveness Scale-Brief (BIS-Brief) Total Score
The BIS-Brief has 8 items rated on a Likert scale. The total score ranges from 8 to 32, with higher scores indicating greater impulsivity.
Time frame
Baseline, post-intervention (week 4), and 3, 6 and 9 months post-interventionOther outcomes
1
Change From Baseline in Interpersonal Dysfunction as Assessed by the SA-45 Interpersonal Sensitivity Subscale Score
This 5-item SA-45 subscale is rated from 0 to 4. The score ranges from 0 to 20, with higher scores indicating greater interpersonal dysfunction.
Time frame
Baseline, post-intervention (week 4), and 3, 6 and 9 months post-interventionLocations
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Source ClinicalTrials.gov
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