Mental Health IssueTeenSleepNCT06306092
Promoting Teenage Sleep for Improved Mental Health and School Performance
A study testing Sleep on Schedule and Technology restriction in people with Mental Health Issue and Insomnia, run by Kristianstad University at 1 site in Sweden.
Trial summary
The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Insomnia, Depression
- What is being tested?
- Sleep on Schedule and Technology restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteSweden
- Study dates
- 17 Aug 2024to 30 Jun 2030
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students in Swedish high schools and upper secondary schools.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serena Bauducco, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Kristianstad University
Kristianstad, Skåne County, 29188
Pernilla Garmy, PhD
About this study
Official title: Promoting Teenage Sleep - for Better Mental Health and School Performance
The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group).
Read the detailed description
Sleep problems are common among young people and there are connections between sleep problems and mental health, concentration problems, and lower grades. Over time (historically since the 80's), teenagers sleep less and less and too little, which affects mental health and school performance in the short term. Long-term lack of sleep increases the risk of leaving school with failed grades and of having long-term health problems. It is therefore important to break this trend.
A challenge in existing preventive sleep programs is to motivate young people to change their sleep habits. Just like adults, teenagers have many activities that demand their time. It can therefore be difficult to balance sleep with schoolwork, exercise, etc. Young people need knowledge about sleep to gain an understanding of how it can affect their mood and ability to cope with school. The reasons for the lack of sleep among young people are multifold: the 24-hour society and easily accessible entertainment/society via technology use, puberty-related changes in the circadian rhythm, and stress about the future. The school has a clear responsibility for the students' knowledge and understanding of the importance of lifestyle for health as well as for supporting the students in orienting themselves in society. The school is therefore a natural arena to reach out to teenagers because most young people are there, and the school health department can offer health-promotion initiatives.
The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group).
Sleep on schedule is a program (5 lessons over 5 weeks) that integrates sleep knowledge and skill training to promote good sleep routines. Technology restriction is a program (2 lessons over 2 weeks) that targets mobile phone use at bedtime. Both programs have shown good results (up to 20 minutes more sleep on school days). The current goal was to test the effects of the programs on young people in a Swedish context to investigate if they can affect teenagers' sleep and mental health.
The study design is a cluster-randomized study where schools are randomized to either 1) Sleep on schedule, 2) Technology restriction, or 3) Control group (no intervention). All schools will be informed of the results and receive training in the program that proves to be most effective at the end of the project, if desired. The intervention is aimed at students aged 13-19. We want to involve large parts of the school's staff and avoid that knowledge and responsibility resting on a few members of staff. The program will be delivered by teachers or school health professionals (e.g., school counsellor, school nurse).
The interventions will directly benefit young people because sleep problems are a risk factor for mental illness and worse school performance. Sleep on schedule and restricting use of technology are important life skills and strategies that can help young people manage their everyday lives both now and in the future. The study offers benefits to the students in the intervention group in that they can learn strategies for preventive purposes regarding sleep before clinical problems arise. The participants will also have their voices heard on the subject.
- Conditions
- Mental Health Issue, Insomnia, Depression, Anxiety, Daytime Sleepiness, Wellness, Psychological
- Being tested
- Sleep on Schedule, Technology restriction
- Keywords
- Sleep, Mental health, Adolescents, School-based intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders, Disorders of Excessive Somnolence, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep on ScheduleBehavioural
Sleep education at school
Technology restrictionBehavioural
Reduction of electronic media use before bedtime
| Study group | Role | What they receive |
|---|---|---|
| "Sleep on Schedule" - sleep education at school | Experimental | The sleep training includes five lessons during school hours, and will be held by school staff (teachers, school nurses and school counsellors). The teaching consists of sleep education (sleep knowledge and good sleep routines), time management (e.g., planning homework without distraction, planning other activities, quiet time before bedtime), information to guardians, and discussions with peers in the classroom (e.g., rules regarding evening interaction via electronic media). Homework/exercises and behavioral experiments are also included. Data collection takes place in connection with the first and last lesson of Sleep on Schedule. Receives: Behavioral: Sleep on Schedule |
| "TechRest" - reduction of electronic media use before bedtime | Experimental | This intervention has been tested in Australia with a small sample of teenagers, and it was associated with promising effects. The data collection consists of a digital questionnaire regarding sleep habits, insomnia, motivation, physical and mental health, and electronic media use; a selection of students will use the actigraph for a week. After the first week, the participants will be instructed to stop using screens 1 hour before their usual bedtime. After one week has passed, participants in the Technology restriction intervention will be asked to complete the previously mentioned questionnaires as well as questions about the intervention itself: its applicability, compliance, and whether or not they will continue to limit their screen time before bedtime. One year after the intervention, they will be asked to complete the same questionnaire as at baseline. A selection of students will also wear a wrist actigraph. Receives: Behavioral: Technology restriction |
| Control | No intervention | School as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep duration, hours and minutes
Self reported average time for sleep onset, time awake during the night and time for wakening in the morning, school days and weekends
Measured: Baseline, 3 month, 1 year
Secondary outcomes (8)
Change in Hospital Anxiety and Depression Scale scores
Hospital Anxiety and Depression Scale measures anxiety and depression with 7 items for anxiety (range 0-21, higher scores mean worse outcome) and 7 items measure depression (range 0-21, higher scores mean worse outcome).
Measured: Baseline, 3 month, 1 year
Change in Adolescent Sleep Hygiene Scale scores
Adolescent Sleep Hygiene Scale measures sleep habits, range 10-60, higher scores mean worse outcome.
Measured: Baseline, 3 month, 1 year
Change in Insomnia Severity Index score
The Insomnia Severity Index (ISI) is a 7-item scale that asesses the severity of sleep disturbance, how much sleep disturbance interferes with daily life and functioning, the noticeability of these impairments to others, worry and distress resulting from sleep disturbance, and general sleep satisfaction/dissatisfaction. Responses are provided on a Likert-scale (0-4). The total score ranges from 0 to 28, and higher scores indicate more severe problems
Measured: Baseline, 3 month, 1 year
Change in EuroQol Visual Analog Scale (EQ VAS) score
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: Baseline, 3 month, 1 year
Change in Sleep knowledge
Sleep knowledge is measured with 9 questions, range 0-9, higher scores mean better sleep knowledge.
Measured: Baseline, 3 month, 1 year
Change in electronic media use
Electronic media use is measured with 3 questions, range 3-12, higher scores mean more bedtime elecronic media use.
Measured: Baseline, 3 month, 1 year
Change in sleep habits
Sleep habits regarding school days and weekends are measured with 10 questions.
Measured: Baseline, 3 month, 1 year
Change in motivation
The Academic Self-Regulation Questionnaire (SRQ-A) - Intrinsic motivation subscale Why I do things measuer motivation. Range 7-28, higher scores mean worse outcome.
Measured: Baseline, 3 month, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start17 Aug 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kristianstad University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Örebro University, Sweden, Region Stockholm
- Responsible party
- Principal investigator, Pernilla Garmy, Kristianstad University
- Investigators
- Annika Norell, PhD, Principal investigator, Örebro University, SwedenChristina Sandlund, PhD, Principal investigator, Karolinska InstitutetPernilla Garmy, PhD, Principal investigator, Kristianstad UniversitySerena Bauducco, PhD, Principal investigator, Örebro University, SwedenGita Hedin, PhD, Principal investigator, Kristianstad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306092
- Sponsor's protocol ID
- 2023-02885-01
- Other IDs
- 2023
- Acronym
- TeenSleep
- Status last verified
- Mar 2026
- First submitted
- 30 Nov 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact pernilla.garmy@hkr.se
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Teenage Sleep - for Better Mental Health and School Performance
- ClinicalTrials.gov ID
- NCT06306092
- Acronym / sponsor ID
- TeenSleep / 2023-02885-01
- Conditions
- Mental Health Issue, Insomnia, Depression, Anxiety, Daytime Sleepiness, Wellness, Psychological
- Keywords
- Sleep, Mental health, Adolescents, School-based intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Kristianstad UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Örebro University, Sweden, Region Stockholm
- Study start
- 17 Aug 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 12 Mar 2024 (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.
The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group).
Detailed description
Sleep problems are common among young people and there are connections between sleep problems and mental health, concentration problems, and lower grades. Over time (historically since the 80's), teenagers sleep less and less and too little, which affects mental health and school performance in the short term. Long-term lack of sleep increases the risk of leaving school with failed grades and of having long-term health problems. It is therefore important to break this trend.
A challenge in existing preventive sleep programs is to motivate young people to change their sleep habits. Just like adults, teenagers have many activities that demand their time. It can therefore be difficult to balance sleep with schoolwork, exercise, etc. Young people need knowledge about sleep to gain an understanding of how it can affect their mood and ability to cope with school. The reasons for the lack of sleep among young people are multifold: the 24-hour society and easily accessible entertainment/society via technology use, puberty-related changes in the circadian rhythm, and stress about the future. The school has a clear responsibility for the students' knowledge and understanding of the importance of lifestyle for health as well as for supporting the students in orienting themselves in society. The school is therefore a natural arena to reach out to teenagers because most young people are there, and the school health department can offer health-promotion initiatives.
The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group).
Sleep on schedule is a program (5 lessons over 5 weeks) that integrates sleep knowledge and skill training to promote good sleep routines. Technology restriction is a program (2 lessons over 2 weeks) that targets mobile phone use at bedtime. Both programs have shown good results (up to 20 minutes more sleep on school days). The current goal was to test the effects of the programs on young people in a Swedish context to investigate if they can affect teenagers' sleep and mental health.
The study design is a cluster-randomized study where schools are randomized to either 1) Sleep on schedule, 2) Technology restriction, or 3) Control group (no intervention). All schools will be informed of the results and receive training in the program that proves to be most effective at the end of the project, if desired. The intervention is aimed at students aged 13-19. We want to involve large parts of the school's staff and avoid that knowledge and responsibility resting on a few members of staff. The program will be delivered by teachers or school health professionals (e.g., school counsellor, school nurse).
The interventions will directly benefit young people because sleep problems are a risk factor for mental illness and worse school performance. Sleep on schedule and restricting use of technology are important life skills and strategies that can help young people manage their everyday lives both now and in the future. The study offers benefits to the students in the intervention group in that they can learn strategies for preventive purposes regarding sleep before clinical problems arise. The participants will also have their voices heard on the subject.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Sleep on Schedule" - sleep education at school | Experimental | Behavioral: Sleep on ScheduleThe sleep training includes five lessons during school hours, and will be held by school staff (teachers, school nurses and school counsellors). The teaching consists of sleep education (sleep knowledge and good sleep routines), time management (e.g., planning homework without distraction, planning other activities, quiet time before bedtime), information to guardians, and discussions with peers in the classroom (e.g., rules regarding evening interaction via electronic media). Homework/exercises and behavioral experiments are also included. Data collection takes place in connection with the first and last lesson of Sleep on Schedule. |
| "TechRest" - reduction of electronic media use before bedtime | Experimental | Behavioral: Technology restrictionThis intervention has been tested in Australia with a small sample of teenagers, and it was associated with promising effects. The data collection consists of a digital questionnaire regarding sleep habits, insomnia, motivation, physical and mental health, and electronic media use; a selection of students will use the actigraph for a week. After the first week, the participants will be instructed to stop using screens 1 hour before their usual bedtime. After one week has passed, participants in the Technology restriction intervention will be asked to complete the previously mentioned questionnaires as well as questions about the intervention itself: its applicability, compliance, and whether or not they will continue to limit their screen time before bedtime. One year after the intervention, they will be asked to complete the same questionnaire as at baseline. A selection of students will also wear a wrist actigraph. |
| Control | No intervention | –School as usual |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Students in Swedish high schools and upper secondary schools.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Sleep on ScheduleSleep education at school | Behavioural | "Sleep on Schedule" - sleep education at school |
| Technology restrictionReduction of electronic media use before bedtime | Behavioural | "TechRest" - reduction of electronic media use before bedtime |
Primary outcome
Change in sleep duration, hours and minutes
Time frame: Baseline, 3 month, 1 year
Self reported average time for sleep onset, time awake during the night and time for wakening in the morning, school days and weekends
8 secondary outcomes
Change in Hospital Anxiety and Depression Scale scores
Time frame: Baseline, 3 month, 1 year
Change in Adolescent Sleep Hygiene Scale scores
Time frame: Baseline, 3 month, 1 year
Change in Insomnia Severity Index score
Time frame: Baseline, 3 month, 1 year
Change in EuroQol Visual Analog Scale (EQ VAS) score
Time frame: Baseline, 3 month, 1 year
Change in Sleep knowledge
Time frame: Baseline, 3 month, 1 year
Change in electronic media use
Time frame: Baseline, 3 month, 1 year
Change in sleep habits
Time frame: Baseline, 3 month, 1 year
Change in motivation
Time frame: Baseline, 3 month, 1 year
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 5 Mar 2026.
- Individual participant dataSharing planned: Yes. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact pernilla.garmy@hkr.se
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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.
Serena Bauducco, PhD contact
Annika Norell, PhD principal investigator
Örebro University, Sweden
Christina Sandlund, PhD principal investigator
Karolinska Institutet
Pernilla Garmy, PhD principal investigator
Kristianstad University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep on Schedule and Technology restriction in people with Mental Health Issue and Insomnia, run by Kristianstad University at 1 site in Sweden.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Pernilla Garmy, PhD (+46739791316, pernilla.garmy@hkr.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep duration, hours and minutes (time frame: Baseline, 3 month, 1 year). 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 5 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.