CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 101 enrolled
Drug / intervention
i-Sleep & BioClock Interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05363995
NCT05363995N/ACompleted

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

Leiden University·interventional·Posted May 6, 2022·Updated Aug 2, 2023

In Brief

A clinical study evaluating i-Sleep & BioClock Intervention for Insomnia. Completed, enrolled 101 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 6, 2022
Enrollment StartMay 1, 2022
Primary CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.2 years ago

Interventions

i-Sleep & BioClock Interventionbehavioral

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.