Clinical trial NCT05363995: Feasibility Trial i-Sleep & BioClock Intervention
Official title: Feasibility and Preliminary Effectiveness of a Blended E-health Intervention for Improving Sleep and the Biological Clock Among University Students (i-Sleep & BioClock)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: sleep
biological clock
CBTi
e-health intervention
university students
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 101
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm open feasibility study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Change from baseline (T0) to 7 weeks after baseline (T1)
Secondary outcomes:
measure: Sleep and light exposure diary
timeFrame: Change from week 0 (7 days prior to intervention period) to week 8 (7 days after T1)
measure: Munich Chronotype Questionnaire (MCTQ)
timeFrame: Change from baseline (T0) to 7 weeks after baseline (T1)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline (T0) to 7 weeks after baseline (T1)
measure: Generalised Anxiety Disorder scale (GAD-7)
timeFrame: Change from baseline (T0) to 7 weeks after baseline (T1)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Change from baseline (T0) to 7 weeks after baseline (T1)
measure: Mental Health Quality of Life questionnaire (MHQoL)
timeFrame: Change from baseline (T0) to 7 weeks after baseline (T1)
Other outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 7 weeks after baseline (T1)
measure: System Usability Scale (SUS-10)
timeFrame: 7 weeks after baseline (T1)
measure: Working Alliance Inventory for guided Internet interventions (WAI-I)
timeFrame: 7 weeks after baseline (T1)
measure: Acceptability and usability of the sleep & light exposure diary
timeFrame: 7 weeks after baseline (T1)
measure: Adherence to the program
timeFrame: Through study completion, on average 7 weeks
Locations:
city: Leiden
country: Netherlands
facility: Leiden Univeristy
state: North Holland
Study officials:
affiliation: Leiden University
name: Niki Antypa, PhD
role: PRINCIPAL_INVESTIGATOR
References: