Feasibility Trial i-Sleep & BioClock Intervention

L

Leiden University

Status

Completed

Conditions

Insomnia

Treatments

Behavioral: i-Sleep & BioClock Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05363995
BioClockWP1.4

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

101 participants in 1 patient group

Experimental
Experimental group
Description:
Blended e-health intervention
Treatment:
Behavioral: i-Sleep & BioClock Intervention

Trial contacts and locations

1

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Central trial contact

Laura Pape, MSc.

Data sourced from clinicaltrials.gov

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