Promoting Teenage Sleep for Improved Mental Health and School Performance

NCT06306092 | Recruiting

• 1 other identifier: 2023-02885-01
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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. The students will be compared to teaching as usual (control group).

Conditions

Mental Health Issue; Insomnia; Depression; Anxiety; Daytime Sleepiness; Wellness, Psychological

Keywords

Sleep; Mental health; Adolescents; School-based intervention

Outcome Measures

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

  Baseline, 3 month, 1 year

Secondary Outcomes (8)

• Change in Hospital Anxiety and Depression Scale scores

  Baseline, 3 month, 1 year

• Change in Adolescent Sleep Hygiene Scale scores

  Baseline, 3 month, 1 year

• Change in Insomnia Severity Index score

  Baseline, 3 month, 1 year

• Change in EuroQol Visual Analog Scale (EQ VAS) score

  Baseline, 3 month, 1 year

• Change in Sleep knowledge

  Baseline, 3 month, 1 year

Study Arms (3)

"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.

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.

Behavioral: Technology restriction

Control

NO INTERVENTION

School as usual

Interventions

Sleep on Schedule BEHAVIORAL

Sleep education at school

"Sleep on Schedule" - sleep education at school

Technology restriction BEHAVIORAL

Reduction of electronic media use before bedtime

"TechRest" - reduction of electronic media use before bedtime

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Students in Swedish high schools and upper secondary schools.

Sponsors & Collaborators

• Kristianstad University: lead
• Karolinska Institutet: collaborator
• Örebro University, Sweden: collaborator
• Academic Primary Health Care Centre, Region Stockholm: collaborator

Study Sites (1)

Kristianstad University

Kristianstad, Skåne County, 29188, Sweden

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Anxiety Disorders; Disorders of Excessive Somnolence; Psychological Well-Being

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Annika Norell, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

• Christina Sandlund, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Pernilla Garmy, PhD

  Kristianstad University

  PRINCIPAL INVESTIGATOR

• Serena Bauducco, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

• Gita Hedin, PhD

  Kristianstad University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pernilla Garmy, PhD

CONTACT

+46739791316; pernilla.garmy@hkr.se

Serena Bauducco, PhD

CONTACT

Serena.Bauducco@oru.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: March 12, 2024
• Study Start: August 17, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2030
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 2030-2035

Locations

SE (1)