Feasibility Trial i-Sleep & BioClock Intervention

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)

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101 participants in 1 patient group

Experimental

Experimental group

Description:

Blended e-health intervention

Treatment:

Behavioral: i-Sleep & BioClock Intervention