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Effectiveness of a Guided Self-help Intervention for Improving Sleep in University Students - Trial NCT06023693

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.

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NCT06023693
Not yet recruiting
behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06023693
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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)

Study Focus

Insomnia

i-Sleep & BioClock

Interventional

behavioral

Sponsor & Location

Leiden University Medical Center

Leiden, Netherlands

Timeline & Enrollment

N/A

Nov 01, 2023

Oct 01, 2024

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 insomnia
Disorders of initiating and maintaining sleep [insomnias]
Sleep disorders
Sleep disorder, unspecified
Other sleep disorders

Data Source

ClinicalTrials.gov

NCT06023693

Non-Device Trial