Sleep DisturbanceSLEEP-TEENNCT07865728
Transdiagnostic Sleep Intervention to Improve Mental Health in Adolescents
A study testing Transdiagnostic Intervention for Sleep and Circadian Dysfunction and Healthy habits psychoeducation in people with Sleep Disturbance and Sleep Problems, run by Universidad Pública de Navarra.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Sleep Problems, Substance Use (Drugs, Alcohol)
- What is being tested?
- Transdiagnostic Intervention for Sleep and Circadian Dysfunction and Healthy habits psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2026to 10 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of a School-Based Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) on Sleep and Mental Health in Spanish Adolescents: A Cluster Randomized Controlled 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:
Read more
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.
Read the detailed description
Background. Adolescence is a period of heightened vulnerability to mental health problems, and insufficient or poor-quality sleep is highly prevalent in this age group. Sleep disturbance is associated with both internalizing (e.g., depression, anxiety) and externalizing problems (e.g., substance use) and is considered a transdiagnostic factor. TranS-C (Harvey \& Buysse, 2018) is a cognitive-behavioral intervention that targets a broad range of sleep and circadian problems from a common framework. However, school-based preventive sleep interventions remain scarce, and none has been evaluated in Spain.
Design. Two-arm, parallel-group, cluster randomized controlled trial with a pre-post design and 3-, 6- and 9-month follow-ups. The unit of randomization is the school. Public secondary schools in Navarre, including both Spanish- and Basque-language schools, will be stratified by location (urban vs. rural). Schools will be computer-randomized within strata in a 1:1 ratio to TranS-C or control. Reserve schools will be randomized in advance to replace schools that decline or withdraw. One reserve school will host a pilot implementation before the main trial to refine the adapted protocol.
Interventions. TranS-C will be adapted to a group, school-based format for Spanish adolescents in collaboration with its developer (Dr. Allison Harvey, University of California, Berkeley). The adaptation includes translation and cultural adaptation of materials. The control condition is a healthy-habits psychoeducation program (nutrition, physical activity, appropriate social media use, hygiene) matched in number and duration of sessions. Both programs are delivered in school hours by psychologists trained in both protocols.
Assessments. Self-report questionnaires are administered online in group sessions at school (baseline and post-intervention) and online at follow-ups. Questionnaire order is counterbalanced. Participants are identified by an anonymous code to link assessments.
Statistical analysis. Intervention effects over time will be estimated with generalized linear mixed models (GLMMs). These models include random intercepts and slopes to account for the nesting of repeated measures within participants and of participants within schools, and they adjust for sex, age, socioeconomic status, school location and the delivering psychologist. Analyses will follow the intention-to-treat principle. Missing data will be handled by multiple imputation. Exploratory mediation analyses will examine whether changes in sleep mediate changes in psychological symptoms. The significance level is set at α = .05.
- Being tested
- Transdiagnostic Intervention for Sleep and Circadian Dysfunction, Healthy habits psychoeducation
- Keywords
- adolescents, sleep, circadian rhythm, transdiagnostic, TranS-C, school-based intervention, psychology, substance use
- Medical subject headings
- Parasomnias, Substance-Related Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic Intervention for Sleep and Circadian DysfunctionBehavioural
It 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 psychoeducationBehavioural
Attention-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.
| Study group | Role | What they receive |
|---|---|---|
| Transdiagnostic Intervention for Sleep and Circadian Dysfunction | Experimental | Group, school-based adaptation of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction. It 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. Receives: Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction |
| Healthy habits psychoeducation | Active comparator | Attention-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. Receives: Behavioral: Healthy habits psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention
Secondary outcomes (5)
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.
Measured: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention
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.
Measured: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention
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.
Measured: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention
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.
Measured: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention
Change From Baseline in Reward Responsiveness as Assessed by the BIS/BAS Scales Reward Responsiveness Subscale Score
The Reward Responsiveness subscale of the BIS/BAS Scales (Carver \& White, 1994) has 5 items, each rated from 1 (very false for me) to 4 (very true for me). The score ranges from 5 to 20, with higher scores indicating greater reward responsiveness.
Measured: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start9 Oct 2026 (estimated)
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized trial; schools randomized 1:1 to TranS-C or healthy-habits control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Pública de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Sancho, Universidad Pública de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865728
- Sponsor's protocol ID
- PJUPNA2026-12573
- Acronym
- SLEEP-TEEN
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying published results will be deposited in the institutional repository
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a School-Based Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) on Sleep and Mental Health in Spanish Adolescents: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07865728
- Acronym / sponsor ID
- SLEEP-TEEN / PJUPNA2026-12573
- Keywords
- adolescents, sleep, circadian rhythm, transdiagnostic, TranS-C, school-based intervention, psychology, substance use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Universidad Pública de NavarraUniversity, hospital or other
- Study start
- 9 Oct 2026 (estimated)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background. Adolescence is a period of heightened vulnerability to mental health problems, and insufficient or poor-quality sleep is highly prevalent in this age group. Sleep disturbance is associated with both internalizing (e.g., depression, anxiety) and externalizing problems (e.g., substance use) and is considered a transdiagnostic factor. TranS-C (Harvey \& Buysse, 2018) is a cognitive-behavioral intervention that targets a broad range of sleep and circadian problems from a common framework. However, school-based preventive sleep interventions remain scarce, and none has been evaluated in Spain.
Design. Two-arm, parallel-group, cluster randomized controlled trial with a pre-post design and 3-, 6- and 9-month follow-ups. The unit of randomization is the school. Public secondary schools in Navarre, including both Spanish- and Basque-language schools, will be stratified by location (urban vs. rural). Schools will be computer-randomized within strata in a 1:1 ratio to TranS-C or control. Reserve schools will be randomized in advance to replace schools that decline or withdraw. One reserve school will host a pilot implementation before the main trial to refine the adapted protocol.
Interventions. TranS-C will be adapted to a group, school-based format for Spanish adolescents in collaboration with its developer (Dr. Allison Harvey, University of California, Berkeley). The adaptation includes translation and cultural adaptation of materials. The control condition is a healthy-habits psychoeducation program (nutrition, physical activity, appropriate social media use, hygiene) matched in number and duration of sessions. Both programs are delivered in school hours by psychologists trained in both protocols.
Assessments. Self-report questionnaires are administered online in group sessions at school (baseline and post-intervention) and online at follow-ups. Questionnaire order is counterbalanced. Participants are identified by an anonymous code to link assessments.
Statistical analysis. Intervention effects over time will be estimated with generalized linear mixed models (GLMMs). These models include random intercepts and slopes to account for the nesting of repeated measures within participants and of participants within schools, and they adjust for sex, age, socioeconomic status, school location and the delivering psychologist. Analyses will follow the intention-to-treat principle. Missing data will be handled by multiple imputation. Exploratory mediation analyses will examine whether changes in sleep mediate changes in psychological symptoms. The significance level is set at α = .05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized trial; schools randomized 1:1 to TranS-C or healthy-habits control
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic Intervention for Sleep and Circadian Dysfunction | Experimental | Behavioral: Transdiagnostic Intervention for Sleep and Circadian DysfunctionGroup, school-based adaptation of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction. It 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 | Active comparator | Behavioral: Healthy habits psychoeducationAttention-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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdiagnostic Intervention for Sleep and Circadian DysfunctionIt 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. | Behavioural | Transdiagnostic Intervention for Sleep and Circadian Dysfunction |
| Healthy habits psychoeducationAttention-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. | Behavioural | Healthy habits psychoeducation |
Primary outcome
Change from baseline in Sleep Quality assessed by the Brief Pittsburgh Sleep Quality Index (B-PSQI) Global Score and its dimensions.
Time frame: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention
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.
5 secondary outcomes
Change from baseline in Depressive Symptoms as Assessed by the SA-45 Depression Subscale Score and the DASS subscale for depression
Time frame: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention
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
Time frame: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention
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)
Time frame: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention
Change From Baseline in Impulsivity as Assessed by the Barratt Impulsiveness Scale-Brief (BIS-Brief) Total Score
Time frame: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention
Change From Baseline in Reward Responsiveness as Assessed by the BIS/BAS Scales Reward Responsiveness Subscale Score
Time frame: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying published results will be deposited in the institutional repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic Intervention for Sleep and Circadian Dysfunction and Healthy habits psychoeducation in people with Sleep Disturbance and Sleep Problems, run by Universidad Pública de Navarra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clara Sancho-Domingo, PhD (+34 948 169522, clara.sancho@unavarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Sleep Quality assessed by the Brief Pittsburgh Sleep Quality Index (B-PSQI) Global Score and its dimensions. (time frame: Baseline, post-intervention (week 4), and 3, 6 and 9 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.