NCT05363995

Feasibility Trial i-Sleep & BioClock Intervention

Feasibility and Preliminary Effectiveness of a Blended E-health Intervention for Improving Sleep and the Biological Clock Among University Students (i-Sleep & BioClock)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Leiden University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2022-05-06
• Last updated: 2023-08-02

Locations

1 site across 1 country: Netherlands