InsomniaNCT06023693
Effectiveness of a Guided Self-help Intervention for Improving Sleep in University Students
A study testing i-Sleep & BioClock and Online Psychoeducation in people with Insomnia, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- i-Sleep & BioClock and Online Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being fluent in Dutch and/or English
- 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
Who cannot join
- Regular night shifts (Not being able to comply to the intervention due to regular night shift, meaning work between 2AM and 6AM at least once a week)
- Current risk for suicidal behaviour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Effectiveness of a Guided E-health Sleep and Biological Clock Intervention in University Students (i-Sleep & BioClock)
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.
Read the 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 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
- Insomnia
- Being tested
- i-Sleep & BioClock, Online Psychoeducation
- Keywords
- sleep, guided self-help, CBTi, e-health, university students
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-Sleep & BioClockBehavioural
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 PsychoeducationBehavioural
Online psychoeducation about sleep and the biological clock, basic sleep hygiene
| Study group | Role | What they receive |
|---|---|---|
| Guided online self-help intervention | Experimental | 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. Receives: Behavioral: i-Sleep & BioClock |
| Online psychoeducation | Active comparator | 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. Receives: Behavioral: Online Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity
Measured: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Secondary outcomes (15)
Sleep efficiency (in minutes)
Derived from sleep and light exposure diary
Measured: Change from week 1 to week 7
Sleep onset latency (in minutes)
Derived from sleep and light exposure diary
Measured: Change from week 1 to week 7
Wake after sleep onset (in minutes)
Derived from sleep and light exposure diary
Measured: Change from week 1 to week 7
Early morning awakening (in minutes)
Derived from sleep and light exposure diary
Measured: Change from week 1 to week 7
Total sleep time (in minutes)
Derived from sleep and light exposure diary
Measured: Change from week 1 to week 7
Time spent outside (in minutes)
Derived from sleep and light exposure diary
Measured: Change from week 1 to week 7
Screen use before bed
Yes/ No question. Derived from sleep and light exposure diary
Measured: Change from week 1 to week 7
Munich Chronotype Questionnaire (MCTQ)
Self-rated scale to assess individual phase of entrainment on work and work-free days, Addresses questions about: bedtime (actual time), time spent in bed awake before deciding to turn off the lights (in minutes), how long it takes to fall asleep (in minutes), wake up time (actual time), get up time (actual time) on work and work-free days. MCTQ uses the midpoint between sleep on- and offset on free days (mid-sleep on free days, MSF) to assess chronotype. The MCTQ chronotype is expressed in local time, in which earlier time refers to earlier chronotype and later time to later chronotype.
Measured: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Patient Health Questionnaire (PHQ-9)
9-items self-report instrument for severity of depressive symptoms, scores ranging from 0-27, higher scores indicating more severe depression
Measured: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Generalised Anxiety Disorder scale (GAD-7)
7-items self-report instrument for severity of anxiety symptoms, scores ranging from 0-21, higher scores indicating more severe anxiety
Measured: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Work and Social Adjustment Scale (WSAS)
5-item self-report instrument for impairment of functioning, scores ranging from 0-40, higher scores indicating more impairment in functioning
Measured: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Mental Health Quality of Life questionnaire (MHQoL)
7-item self report instrument for quality of life measure for use in people with mental health problems, scores ranging from 0-21, higher scores indicating higher quality of life, and MHQoL-VAS visual scale ranging from 0 (worst imaginable psychological wellbeing) to 10 (best imaginable psychological wellbeing)
Measured: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Dysfunctional beliefs and attitudes about sleep (DBAS-10)
10-item abbreviated measure for dysfunctional beliefs and attitudes about sleep, scored on a scale from 0 (strongly disagree) to 10 (strongly agree)
Measured: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)
Pre-Sleep Arousal Scale (PSAS)
16-item self report instrument for pre-sleep arousal, 5-point Likert Scale, higher scores reflecting more arousal
Measured: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)
Academic performance
Students will be asked about the grade of their last exam (Scale 1-10), the average grade of the past semester (Scale 1-10), whether they failed any exams in the past semester (Yes/No), and their study progression in the past semester in terms of ECTS achieved (30 ECTS per semester, Yes/No)
Measured: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Nov 2023
- Primary completion1 Nov 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Spinhoven, Leiden University Medical Center
- Investigators
- Niki Antypa, Dr., Principal investigator, Leiden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023693
- Sponsor's protocol ID
- i-Sleep&BioClockRCT
- Status last verified
- Jan 2025
- First submitted
- 3 Aug 2023
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pape LM, van Straten A, Struijs SY, Karch JD, Spinhoven P, Antypa N; Caring Universities Consortium. Effects of a guided digital intervention on sleep and mental health outcomes in university students - a randomized controlled trial. Sleep. 2026 May 12;49(5):zsaf357. doi: 10.1093/sleep/zsaf357.
PubMed 41288591Pape 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.
PubMed 39224668
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effectiveness of a Guided E-health Sleep and Biological Clock Intervention in University Students (i-Sleep & BioClock)
- ClinicalTrials.gov ID
- NCT06023693
- Acronym / sponsor ID
- i-Sleep&BioClockRCT
- Conditions
- Insomnia
- Keywords
- sleep, guided self-help, CBTi, e-health, university students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided online self-help intervention | Experimental | Behavioral: i-Sleep & BioClockThe 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. |
| Online psychoeducation | Active comparator | Behavioral: Online PsychoeducationThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Being fluent in Dutch and/or English
- 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
Key exclusion criteria (2 listed)
- Regular night shifts (Not being able to comply to the intervention due to regular night shift, meaning work between 2AM and 6AM at least once a week)
- Current risk for suicidal behaviour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-Sleep & BioClockModule 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 | Behavioural | Guided online self-help intervention |
| Online PsychoeducationOnline psychoeducation about sleep and the biological clock, basic sleep hygiene | Behavioural | Online psychoeducation |
Primary outcome
Insomnia Severity Index
Time frame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity
15 secondary outcomes
Sleep efficiency (in minutes)
Time frame: Change from week 1 to week 7
Sleep onset latency (in minutes)
Time frame: Change from week 1 to week 7
Wake after sleep onset (in minutes)
Time frame: Change from week 1 to week 7
Early morning awakening (in minutes)
Time frame: Change from week 1 to week 7
Total sleep time (in minutes)
Time frame: Change from week 1 to week 7
Time spent outside (in minutes)
Time frame: Change from week 1 to week 7
Screen use before bed
Time frame: Change from week 1 to week 7
Munich Chronotype Questionnaire (MCTQ)
Time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Generalised Anxiety Disorder scale (GAD-7)
Time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Work and Social Adjustment Scale (WSAS)
Time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Mental Health Quality of Life questionnaire (MHQoL)
Time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Dysfunctional beliefs and attitudes about sleep (DBAS-10)
Time frame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)
Pre-Sleep Arousal Scale (PSAS)
Time frame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)
Academic performance
Time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Derived from this study: PubMed 41288591Pape LM, van Straten A, Struijs SY, Karch JD, Spinhoven P, Antypa N; Caring Universities Consortium. Effects of a guided digital intervention on sleep and mental health outcomes in university students - a randomized controlled trial. Sleep. 2026 May 12;49(5):zsaf357. doi: 10.1093/sleep/zsaf357.
- Derived from this study: PubMed 39224668Pape 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niki Antypa, Dr. principal investigator
Leiden University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-Sleep & BioClock and Online Psychoeducation in people with Insomnia, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06023693, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.