Students often suffer from sleep problems and circadian rhythm disruptions which affect their mental health and daily functioning. The aim of this project is to develop, implement and evaluate an e-health intervention that targets the biological clock and improves the sleep patterns of university students in order to prevent the development or exacerbation of mental health problems. The investigators will assess the feasibility, usability and acceptability of the intervention in this pilot trial.
The primary objective of this study is to evaluate the e-health modules, in terms of overall acceptability, feasibility, and usability. The secondary objective is to evaluate preliminary effectiveness on the outcomes mentioned below.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
101
The 'i-Sleep \& BioClock' intervention aims at improving sleep and the biological clock among university students. It is incorporates evidence-based techniques such as cognitive behavioural therapy for insomnia (CBTi). The intervention has a duration of 5 weeks and consists of five modules: 1. psychoeducation on insomnia, sleep hygiene and the biological clock, 2. stimulus control and sleep restriction therapy, 3. worrying and relaxation exercises, 4. cognitive therapy to change dysfunctional thoughts about sleep, and 5. summary module, relapse prevention, and plan for the future. The intervention is supported by e-coaches who give personalized written feedback. Students will fill in a sleep \& light exposure diary daily.
Leiden Univeristy
Leiden, North Holland, Netherlands
Insomnia Severity Index
7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity
Time frame: Change from baseline (T0) to 7 weeks after baseline (T1)
Sleep and light exposure diary
This diary includes measures such as sleep efficiency, sleep onset latency, total sleep time, wake after sleep onset, number of awakenings, early morning awakening, time spent outside, screen use before bedtime)
Time frame: Change from week 0 (7 days prior to intervention period) to week 8 (7 days after T1)
Munich Chronotype Questionnaire (MCTQ)
Self-rated scale to assess individual phase of entrainment on work and work-free days, Addresses questions about: bedtime, time spent in bed awake before deciding to turn off the lights, how long it takes to fall asleep, wake up time, get up time on work and work-free days. MCTQ uses the midpoint between sleep on- and offset on free days (mid-sleep on free days, MSF) to assess chronotype
Time frame: Change from baseline (T0) to 7 weeks after baseline (T1)
Patient Health Questionnaire (PHQ-9)
9-items self-report instrument for severity of depressive symptoms, scores ranging from 0-27, higher scores indicating more severe depression
Time frame: Change from baseline (T0) to 7 weeks after baseline (T1)
Generalised Anxiety Disorder scale (GAD-7)
7-items self-report instrument for severity of anxiety symptoms, scores ranging from 0-21, higher scores indicating more severe anxiety
Time frame: Change from baseline (T0) to 7 weeks after baseline (T1)
Work and Social Adjustment Scale (WSAS)
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5-item self-report instrument for impairment of functioning, scores ranging from 0-40, higher scores indicating more impairment in functioning
Time frame: Change from baseline (T0) to 7 weeks after baseline (T1)
Mental Health Quality of Life questionnaire (MHQoL)
7-item self report instrument for quality of life measure for use in people with mental health problems, scores ranging from 0-21, higher scores indicating higher quality of life, and MHQoL-VAS visual scale ranging from 0 (worst imaginable psychological wellbeing) to 10 (best imaginable psychological wellbeing)
Time frame: Change from baseline (T0) to 7 weeks after baseline (T1)