Behavioral and Sleep Hygiene Education With Mindfulness Intervention to Improve Sleep Regularity in Adolescents

NCT06028997 | Completed

• 1 other identifier: VSN-23-086
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Sleep plays a fundamental role in both mental- and physical-health, with good sleep health including adequate duration and quality, appropriate timing, regularity, and absence of sleep disorders. The purpose of this study is to evaluate sleep in adolescent and if brief behavioral and sleep hygiene education with mindfulness intervention improves, sleep timing, sleep duration, sleep quality, anxiety- and depression symptoms. During adolescence extensive physiological changes happen that make it easier for adolescents to stay up later, that may increase the time it may take them to fall-asleep and developing insomnia symptoms. At the same time psychosocial changes happen, the societal changes in the last decade may even have further amplified late sleep in adolescents, with increase in social media use and evening screen-time. As sleep need is not decreased and with adolescents having to wake up at "socially acceptable times" rather than the endogenous sleep offset time, sleep duration may be shortened causing chronic sleep loss and daytime sleepiness. Insufficient sleep in adolescents may affect their daytime functioning, causing fatigue and memory issues, affect school attendance and academic performance, affect mood, mental- and physical health, cause behavioral dysfunction and has been associated with worse health outcomes, adverse risk behaviors and even increase risk for accidents.This study should advance understanding of sleep in adolescents and if this simple interventions can be effective in improving their sleep and mental health.

Conditions

Sleep; Depression; Anxiety; Chronotype

Keywords

sleep regularity; sleep duration; adolescents; behavioral therapy; sleep hygiene education; mindfulness intervention

Outcome Measures

Primary Outcomes (5)

• Chronotype and relationship with sleep duration, anxiety- and depression symptoms

  Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if the different chronotype-groups differ in sleep duration (evaluated in hours and minutes)

  Baseline and week 9

• Chronotype and relationship with anxiety symptoms

  Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in anxiety symptoms when evaluated with the general anxiety disorder scale-7 (GAD-7), a seven item validated questionnaire designed to screen for and access severity of anxiety (based on scores from 0-21)

  Baseline and week 9

• Chronotype and relationship with depression symptoms

  Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in depression symptoms when evaluated with the patient health questionnaire (PHQ-9), a nine-item validated questionnaire (scores from 0-27), with higher scores indicating more symptoms

  Baseline and week 9

• Chronotype and relationship with depression symptoms

  Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in depression symptoms when evaluated with the Becks depression inventory (BDI-II) a ten-item questionnaires to screen for and access severity of depression (scores from 0-63) symptoms, with higher scores indicating more symptoms

  Baseline and week 9

• Change in sleep regularity and social jetlag from baseline to follow up after 8-weeks of intervention

  Sleep duration, sleep onset and sleep conclusions (all measured in hours and minutes) to calculate sleep midpoint on school- and free days, to calculate social jetlag (in hours and minutes)

  Baseline and week 9

Study Arms (1)

Intervention arm

EXPERIMENTAL

Behavioral: Behavioral and Sleep Hygiene Education with Mindfulness Intervention

Interventions

Behavioral and Sleep Hygiene Education with Mindfulness Intervention BEHAVIORAL

Education about good sleep hygiene practices and behavior advice to improve sleep based on current literature for 10-15 minutes/week followed by 50 minutes of yoga Nidra and breathing excersices

Intervention arm

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• First year student attending a junior collage in Northern Europe (Akureyri Iceland)

You may not qualify if:

• chronic atrial fibrillation or ventricular trigemini,
• severe uncontrolled asthma or other pulmonary diseases,
• moderate and severe obstructive sleep apnea (OSA)

Sponsors & Collaborators

• Solveig Magnusdottir: lead
• Akureyri Hospital: collaborator

Study Sites (2)

Menntaskolinn a Akureyri

Akureyri, 600, Iceland

Location

Sjukrahusid a Akureyri

Akureyri, 600, Iceland

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Solveig Magnusdottir, MD, MSc, MBA

  MyCardio SleepImage

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Medical Officer

Model Details: Prospective cohort-study

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 8, 2023
• Study Start: August 28, 2023
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IC (2)