Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06023693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-05
First Post:
2023-08-03
Brief Title:
Effectiveness of a Guided Self-help Intervention for Improving Sleep in University Students
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
A Study on the Effectiveness of a Guided E-health Sleep and Biological Clock Intervention in University Students i-Sleep BioClock
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Rationale University students often suffer from sleep problems which affect their mental health and daily functioning Cognitive behavioural therapy for insomnia CBTi has been proven effective in adults but research in university students is still limited The investigators hypothesize that a guided e-health self-help intervention based on CBTi principles i-Sleep BioClock could offer convenient treatment to students with sleep problems by reducing insomnia severity and improving mental health outcomes
Objective The aim of this randomized controlled trial is to assess the effectiveness of a guided e-health sleep and biological clock intervention on sleep mental health symptoms depression and anxiety functioning quality of life and academic performance in university students
Study design This is a two-arm parallel group superiority randomized controlled trial comparing a guided e-health intervention based on CBTi to online psychoeducation PE
Study population The aim is to include 192 university students Bachelor Master and PhD with at least subthreshold insomnia Insomnia Severity Index 10 aged 16 who are able to speak Dutch or English and are affiliated to one of the nine participating universities Students with current suicidal ideation are excluded
Intervention The intervention will be a guided e-health intervention based on CBTi principles i-Sleep BioClock It consists of 5 modules to be completed in about 5 weeks and is aimed at improving sleep in university students The intervention will be entirely held online and will be supported by e-coaches
Main study parametersendpoints The primary outcome will be insomnia severity Secondary outcomes will be depression anxiety daily functioning academic performance quality of life and sleep light exposure diary outcomes Outcomes will be measured at baseline at post-treatment 6 weeks after baseline and at 18 weeks follow-up Mediators such as shift in chronotype and light exposure will be examined at baseline mid-treatment and post-treatment
Objective The aim of this randomized controlled trial is to assess the effectiveness of a guided e-health sleep and biological clock intervention on sleep mental health symptoms depression and anxiety functioning quality of life and academic performance in university students
Study design This is a two-arm parallel group superiority randomized controlled trial comparing a guided e-health intervention based on CBTi to online psychoeducation PE
Study population The aim is to include 192 university students Bachelor Master and PhD with at least subthreshold insomnia Insomnia Severity Index 10 aged 16 who are able to speak Dutch or English and are affiliated to one of the nine participating universities Students with current suicidal ideation are excluded
Intervention The intervention will be a guided e-health intervention based on CBTi principles i-Sleep BioClock It consists of 5 modules to be completed in about 5 weeks and is aimed at improving sleep in university students The intervention will be entirely held online and will be supported by e-coaches
Main study parametersendpoints The primary outcome will be insomnia severity Secondary outcomes will be depression anxiety daily functioning academic performance quality of life and sleep light exposure diary outcomes Outcomes will be measured at baseline at post-treatment 6 weeks after baseline and at 18 weeks follow-up Mediators such as shift in chronotype and light exposure will be examined at baseline mid-treatment and post-treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None