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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Örebro University, Sweden | OTHER |
| Region Stockholm | OTHER_GOV |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "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. |
|
| "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. |
|
| Control | No Intervention | School as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep on Schedule | Behavioral | Sleep education at school |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3 month, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 3 month, 1 year |
| Change in Adolescent Sleep Hygiene Scale scores |
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Inclusion Criteria:
Students in Swedish high schools and upper secondary schools.
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pernilla Garmy, PhD | Contact | +46739791316 | pernilla.garmy@hkr.se | |
| Serena Bauducco, PhD | Contact | Serena.Bauducco@oru.se |
| Name | Affiliation | Role |
|---|---|---|
| Annika Norell, PhD | Örebro University, Sweden | Principal Investigator |
| Christina Sandlund, PhD | Karolinska Institutet | Principal Investigator |
| Pernilla Garmy, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kristianstad University | Recruiting | Kristianstad | Skåne County | 29188 | Sweden |
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
2030-2035
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2024 | Mar 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D006970 | Disorders of Excessive Somnolence |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Technology restriction | Behavioral | Reduction of electronic media use before bedtime |
|
Adolescent Sleep Hygiene Scale measures sleep habits, range 10-60, higher scores mean worse outcome. |
| 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 | 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. | 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. | 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. | Baseline, 3 month, 1 year |
| Change in sleep habits | Sleep habits regarding school days and weekends are measured with 10 questions. | 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. | Baseline, 3 month, 1 year |
| Kristianstad University |
| Principal Investigator |
| Serena Bauducco, PhD | Örebro University, Sweden | Principal Investigator |
| Gita Hedin, PhD | Kristianstad University | Principal Investigator |
| D001523 |
| Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |