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Students often suffer from sleep problems and circadian rhythm disruptions which affect their mental health and daily functioning. The aim of this project is to develop, implement and evaluate an e-health intervention that targets the biological clock and improves the sleep patterns of university students in order to prevent the development or exacerbation of mental health problems. The investigators will assess the feasibility, usability and acceptability of the intervention in this pilot trial.
The primary objective of this study is to evaluate the e-health modules, in terms of overall acceptability, feasibility, and usability. The secondary objective is to evaluate preliminary effectiveness on the outcomes mentioned below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Blended e-health intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i-Sleep & BioClock Intervention | Behavioral | The 'i-Sleep & BioClock' intervention aims at improving sleep and the biological clock among university students. It is incorporates evidence-based techniques such as cognitive behavioural therapy for insomnia (CBTi). The intervention has a duration of 5 weeks and consists of five modules:
The intervention is supported by e-coaches who give personalized written feedback. Students will fill in a sleep & light exposure diary daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | 7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity | Change from baseline (T0) to 7 weeks after baseline (T1) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep and light exposure diary | This diary includes measures such as sleep efficiency, sleep onset latency, total sleep time, wake after sleep onset, number of awakenings, early morning awakening, time spent outside, screen use before bedtime) | Change from week 0 (7 days prior to intervention period) to week 8 (7 days after T1) |
| Measure | Description | Time Frame |
|---|---|---|
| Client Satisfaction Questionnaire (CSQ-8) | 8-item self-report questionnaire for client satisfaction with services, total score ranging from 8-32, higher indicating higher satisfaction | 7 weeks after baseline (T1) |
| System Usability Scale (SUS-10) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niki Antypa, PhD | Leiden University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden Univeristy | Leiden | North Holland | 2333AK | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40593043 | Derived | Pape LM, Antypa N, Spinhoven P, van Straten A, Struijs SY; Caring Universities Consortium. Open pilot study of a guided digital self-help intervention targeting sleep and the biological clock in university students using a pre-test post-test design. Sci Rep. 2025 Jul 1;15(1):21837. doi: 10.1038/s41598-025-04891-8. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Single arm open feasibility study
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|
| Munich Chronotype Questionnaire (MCTQ) |
Self-rated scale to assess individual phase of entrainment on work and work-free days, Addresses questions about: bedtime, time spent in bed awake before deciding to turn off the lights, how long it takes to fall asleep, wake up time, get up 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 |
| Change from baseline (T0) to 7 weeks after baseline (T1) |
| 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 | Change from baseline (T0) to 7 weeks after baseline (T1) |
| 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 | Change from baseline (T0) to 7 weeks after baseline (T1) |
| 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 | Change from baseline (T0) to 7 weeks after baseline (T1) |
| 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) | Change from baseline (T0) to 7 weeks after baseline (T1) |
10-item self-report scale for system usability, five response options for respondents; from strongly agree to strongly disagree, scores ranging from 0-40, higher scores indicating better system usability
| 7 weeks after baseline (T1) |
| Working Alliance Inventory for guided Internet interventions (WAI-I) | 12-item self-report instrument to capture alliance in guided Internet interventions, 5-point Likert scale ranging from 1 (never) to 5 (always), scores ranging from 12-60, higher scores indicating better alliance | 7 weeks after baseline (T1) |
| Acceptability and usability of the sleep & light exposure diary | 11 items on the sleep & light exposure diary, 5 point Likert Scale, scores ranging from 0-44, higher scores indicating better usability and acceptability, one visual scale on usefulness of the diary, 0 (not at all useful) to 10 (Very much useful) | 7 weeks after baseline (T1) |
| Adherence to the program | Will be measured by the total number of completed modules and lessons, time spent in the platform, and the number of logins | Through study completion, on average 7 weeks |
| D001523 |
| Mental Disorders |