Feasibility Trial i-Sleep & BioClock Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility and Preliminary Effectiveness of a Blended E-health Intervention for Improving Sleep and the Biological Clock Among University Students (i-Sleep & BioClock)

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: i-Sleep & BioClock Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being fluent in Dutch and/or English Being enrolled as a student (Bachelor, Master or PhD) in one of the seven participating universities (Leiden University, Vrije Universiteit Amsterdam, Utrecht University, Maastricht University, Erasmus University Rotterdam, University of Amsterdam, Inholland University of Applied Sciences) Being ≥ 16 years old Having self-reported sleep problems; Insomnia Severity Index ≥ 8 (at least subthreshold insomnia) Exclusion Criteria: Current risk for suicidal behaviour

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm open feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Blended e-health intervention | Behavioral: i-Sleep & BioClock Intervention<br>* 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: psychoeducation on insomnia, sleep hygiene and the biological clock, stimulus control and sleep restriction therapy, worrying and relaxation exercises, cognitive therapy to change dysfunctional thoughts about sleep, and 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | 7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity | Change from baseline (T0) to 7 weeks after baseline (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 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 | Change from baseline (T0) to 7 weeks after baseline (T1) | 
| Work and Social Adjustment Scale (WSAS) | 5-item self-report instrument for impairment of functioning, scores ranging from 0-40, higher scores indicating more impairment in functioning | 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) | Change from baseline (T0) to 7 weeks after baseline (T1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, biological clock, CBTi, e-health intervention, university students