Status:
COMPLETED
Feasibility Trial i-Sleep & BioClock Intervention
Lead Sponsor:
Leiden University
Conditions:
Insomnia
Eligibility:
All Genders
16+ years
Phase:
NA
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-he...
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...
Eligibility Criteria
Inclusion
- 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
- Current risk for suicidal behaviour
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT05363995
Start Date
May 1 2022
End Date
December 1 2022
Last Update
August 2 2023
Active Locations (1)
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1
Leiden Univeristy
Leiden, North Holland, Netherlands, 2333AK