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

Depression Clinical Trial

Official title:

Implementation of Behavioral and Sleep Hygiene Education With Mindfulness Intervention to Improve Sleep Regularity in Adolescents; is There a Relationship With Anxiety, Depression or Chronotype

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06028997
• Other study ID #: VSN-23-086
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 28, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: Akureyri Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study is a prospective cohort-study implementing a brief behavioral and sleep hygiene education with mindfulness intervention in adolescents starting a junior collage (16 years of age). All first year students are invited to participate and those interested, willing to sign a consent and have a consent from a parent/guardian will be included in the study, except if diagnosed with chronic atrial fibrillation or ventricular trigemini, severe uncontrolled asthma, or other pulmonary diseases, or diagnosed with moderate or severe obstructive sleep apnea (OSA) then will be excluded from participating in the study.

Sleep duration, sleep timing (sleep onset and conclusion to calculate sleep mid-time and social jetlag), sleep quality, sleep efficiency and wake after sleep onset will be measured with objective home sleep test for three (3) week-nights and two (2) weekend-nights. Sleepiness, insomnia symptoms, anxiety, depression and chronotype will be evaluated with subjective questionnaires before starting intervention of behavioral and sleep hygiene education and mindfulness training once weekly. After the 8-week intervention participants sleep will be measured, sleepiness, insomnia, anxiety, depression symptoms will be re-evaluated with the same questionnaires and their knowledge of how sleep curtailments may affect health and quality of life will be tested.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: May 31, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. chronic atrial fibrillation or ventricular trigemini,

2. severe uncontrolled asthma or other pulmonary diseases,

3. moderate and severe obstructive sleep apnea (OSA)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Sleep

Intervention

Behavioral:
• Behavioral and Sleep Hygiene Education with Mindfulness Intervention
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

Locations

Country	Name	City	State
Iceland	Menntaskolinn a Akureyri	Akureyri
Iceland	Sjukrahusid a Akureyri	Akureyri

Sponsors (2)

Lead Sponsor	Collaborator
Solveig Magnusdottir	Menntaskolin a Akureyri

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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