Feasibility Trial i-Sleep & BioClock Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm open feasibility study

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental

Blended e-health intervention

Group Type EXPERIMENTAL

i-Sleep & BioClock Intervention

Intervention Type BEHAVIORAL

The 'i-Sleep \& BioClock' intervention aims at improving sleep and the biological clock among university students. It is incorporates evidence-based techniques such as cognitive behavioural therapy for insomnia (CBTi). The intervention has a duration of 5 weeks and consists of five modules:

1. psychoeducation on insomnia, sleep hygiene and the biological clock,
2. stimulus control and sleep restriction therapy,
3. worrying and relaxation exercises,
4. cognitive therapy to change dysfunctional thoughts about sleep, and
5. summary module, relapse prevention, and plan for the future.

The intervention is supported by e-coaches who give personalized written feedback. Students will fill in a sleep \& light exposure diary daily.

Interventions

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i-Sleep & BioClock Intervention

The 'i-Sleep \& BioClock' intervention aims at improving sleep and the biological clock among university students. It is incorporates evidence-based techniques such as cognitive behavioural therapy for insomnia (CBTi). The intervention has a duration of 5 weeks and consists of five modules:

1. psychoeducation on insomnia, sleep hygiene and the biological clock,
2. stimulus control and sleep restriction therapy,
3. worrying and relaxation exercises,
4. cognitive therapy to change dysfunctional thoughts about sleep, and
5. summary module, relapse prevention, and plan for the future.

The intervention is supported by e-coaches who give personalized written feedback. Students will fill in a sleep \& light exposure diary daily.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)