Feasibility Trial i-Sleep & BioClock Intervention
- Conditions
- Insomnia
- Interventions
- Behavioral: i-Sleep & BioClock Intervention
- Registration Number
- NCT05363995
- Lead Sponsor
- Leiden University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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)
- Current risk for suicidal behaviour
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental i-Sleep & BioClock Intervention Blended e-health intervention
- Primary Outcome Measures
Name Time Method Insomnia Severity Index Change from baseline (T0) to 7 weeks after baseline (T1) 7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity
- Secondary Outcome Measures
Name Time Method Work and Social Adjustment Scale (WSAS) Change from baseline (T0) to 7 weeks after baseline (T1) 5-item self-report instrument for impairment of functioning, scores ranging from 0-40, higher scores indicating more impairment in functioning
Sleep and light exposure diary Change from week 0 (7 days prior to intervention period) to week 8 (7 days after T1) 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)
Patient Health Questionnaire (PHQ-9) Change from baseline (T0) to 7 weeks after baseline (T1) 9-items self-report instrument for severity of depressive symptoms, scores ranging from 0-27, higher scores indicating more severe depression
Mental Health Quality of Life questionnaire (MHQoL) Change from baseline (T0) to 7 weeks after baseline (T1) 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)
Munich Chronotype Questionnaire (MCTQ) Change from baseline (T0) to 7 weeks after baseline (T1) 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
Generalised Anxiety Disorder scale (GAD-7) Change from baseline (T0) to 7 weeks after baseline (T1) 7-items self-report instrument for severity of anxiety symptoms, scores ranging from 0-21, higher scores indicating more severe anxiety
Trial Locations
- Locations (1)
Leiden Univeristy
🇳🇱Leiden, North Holland, Netherlands