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Feasibility Trial i-Sleep & BioClock Intervention

NCT05363995 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-08-02

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Leiden University

    lead OTHER

Principal Investigators

  • Niki Antypa, PhD · Leiden University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • Netherlands

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05363995 on ClinicalTrials.gov