Promoting Teenage Sleep for Improved Mental Health and School Performance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-19
SponsorKristianstad University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Sleep on Schedule
BehavioralSleep education at school
Technology restriction
BehavioralReduction of electronic media use before bedtime
Treatment groups
3,000 Participants
are divided into 3 treatment groupsGroup A: "Sleep on Schedule" - sleep education at schoolExperimental treatment 1 intervention
Group B: "TechRest" - reduction of electronic media use before bedtimeExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline, 3 month, 1 yearSecondary outcomes
1
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).
Time frame
Baseline, 3 month, 1 year2
Change in Adolescent Sleep Hygiene Scale scores
Adolescent Sleep Hygiene Scale measures sleep habits, range 10-60, higher scores mean worse outcome.
Time frame
Baseline, 3 month, 1 year3
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
Time frame
Baseline, 3 month, 1 year4
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.
Time frame
Baseline, 3 month, 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kristianstad University
Lead sponsor
Karolinska Institutet
Collaborator
Örebro University, Sweden
Collaborator
Region Stockholm
Collaborator
Source ClinicalTrials.gov