Effectiveness of a Guided Self-help Intervention for Improving Sleep in University Students
NCT ID: NCT06023693
Last Updated: 2025-02-03
Study Results
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Basic Information
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COMPLETED
NA
195 participants
INTERVENTIONAL
2023-11-01
2025-01-01
Brief Summary
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Detailed Description
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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 parameters/endpoints: 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Guided online self-help 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. The topics covered will be sleep hygiene, psychoeducation on sleep and the biological clock, sleep restriction, stimulus control, worrying and relaxation, dysfunctional thoughts, and relapse prevention.
i-Sleep & BioClock
Module 1 Psychoeducation about normal sleep and insomnia, Psychoeducation on the biological clock: the circadian rhythm, chronotypes, zeitgebers, importance of light behaviour Basic sleep hygiene: information about behaviours that are known to promote or impede sleep e.g. performing physical exercise or the use of caffeine Module 2 Sleep restriction and stimulus control: patients are taught to use the bedroom only to sleep and to restrict the time in bed to the average amount of night-time sleep Module 3 Worrying and relaxation: audio files with progressive muscle relaxation exercises are offered and techniques to stop worrying (e.g. thought blocking, evaluation and worry time) Module 4 Erroneous cognitions about sleep: the basics of cognitive behavioural therapy are explained and the most common erroneous ideas about insomnia are discussed Module 5 Summary and plan for the future
Online psychoeducation
The control group will receive access to the platform and to the sleep diary. Their intervention will consist of brief, unstructured online PE for insomnia based on recognized sleep hygiene advice, for example, recommendations about evening routines, and use of alcohol and caffeine. Students will be advised to monitor their sleep in the diary. In contrast to the intervention group, the control group will not receive support of an e-coach. Key differences to the CBTi group are that the online PE (1) does not provide individualized support by an e-coach; (2) includes less content, and (3) is not delivered in a step-by-step manner, but will be provided all at once.
Online Psychoeducation
Online psychoeducation about sleep and the biological clock, basic sleep hygiene
Interventions
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i-Sleep & BioClock
Module 1 Psychoeducation about normal sleep and insomnia, Psychoeducation on the biological clock: the circadian rhythm, chronotypes, zeitgebers, importance of light behaviour Basic sleep hygiene: information about behaviours that are known to promote or impede sleep e.g. performing physical exercise or the use of caffeine Module 2 Sleep restriction and stimulus control: patients are taught to use the bedroom only to sleep and to restrict the time in bed to the average amount of night-time sleep Module 3 Worrying and relaxation: audio files with progressive muscle relaxation exercises are offered and techniques to stop worrying (e.g. thought blocking, evaluation and worry time) Module 4 Erroneous cognitions about sleep: the basics of cognitive behavioural therapy are explained and the most common erroneous ideas about insomnia are discussed Module 5 Summary and plan for the future
Online Psychoeducation
Online psychoeducation about sleep and the biological clock, basic sleep hygiene
Eligibility Criteria
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Inclusion Criteria
* Being enrolled as a student (Bachelor, Master or PhD) in one of the Caring Universities partner universities
* Being ≥ 16 years old
* Having self-reported sleep problems; Insomnia Severity Index ≥ 10
Exclusion Criteria
* Current risk for suicidal behaviour
16 Years
ALL
Yes
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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Philip Spinhoven
Prof. dr. Philip Spinhoven
Principal Investigators
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Niki Antypa, Dr.
Role: PRINCIPAL_INVESTIGATOR
Leiden University
Locations
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Leiden Univeristy
Leiden, , Netherlands
Countries
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References
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Pape LM, van Straten A, Struijs SY, Spinhoven P, Antypa N. Effectiveness of a guided digital self-help intervention to improve sleep and the biological clock in university students - Study protocol for a randomized controlled trial. Internet Interv. 2024 Aug 2;37:100763. doi: 10.1016/j.invent.2024.100763. eCollection 2024 Sep.
Other Identifiers
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i-Sleep&BioClockRCT
Identifier Type: -
Identifier Source: org_study_id
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