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NCT06023693Not yet recruiting

Effectiveness of a Guided Self-help Intervention for Improving Sleep in University Students

A Study on the Effectiveness of a Guided E-health Sleep and Biological Clock Intervention in University Students (i-Sleep & BioClock)
Leiden University Medical CenterClinicalTrials.govbehavioral
Verified
Study focus
Disease/Condition
Insomnia
Drug/Device/Intervention
i-Sleep & BioClock
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Leiden University Medical Center
Location
Leiden, Netherlands
Timeline & enrollment
Phase
N/A
Start date
Nov 01, 2023
End date
Oct 01, 2024
Enrollment
192 participants
Primary outcome

Insomnia Severity Index

Summary

This randomized controlled trials aims to assess the effectiveness of an online guided
 self-help intervention ('i-Sleep & BioClock') based on CBTi principles for university
 students' sleep problems. The study will involve 192 students with subthreshold insomnia who
 will be randomized to the intervention or online psychoeducation. The intervention consists
 of 5 modules completed in about 5 weeks, supported by e-coaches. Outcomes include insomnia
 severity, mental health symptoms, functioning, quality of life, and academic performance,
 measured at baseline, post-treatment (6 weeks after baseline), and 18 weeks follow-up.

ICD-10 classifications
Nonorganic insomniaDisorders of initiating and maintaining sleep [insomnias]Sleep disordersSleep disorder, unspecifiedOther sleep disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06023693
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06023693 through Pure Global AI's free database. This phase not specified trial is sponsored by Leiden University Medical Center and is currently Not yet recruiting. The study focuses on Insomnia. Target enrollment is 192 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.