Evidence map›Paper›PMID 41288591›Full record

Trial reportSleep2026

Effects of a guided digital intervention on sleep and mental health outcomes in university students - a randomized controlled trial.

Laura Michelle Pape, Annemieke van Straten, Sascha Yuri Struijs, Julian David Karch, Philip Spinhoven, Niki Antypa, Caring Universities Consortium

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Sleep, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06023693 (A Study on the Effectiveness of a Guided E-health Sleep and Biological Clock Intervention in University Students), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06023693 nacompletednot on this map

A Study on the Effectiveness of a Guided E-health Sleep and Biological Clock Intervention in University Students (i-Sleep & BioClock)

TypeinterventionalSponsorLeiden University Medical CenterRan2023 to 2025Enrolled195ConditionsInsomniaArmsi-Sleep & BioClock, Online Psychoeducation
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Laura Michelle PapeDepartment of Clinical Psychology, Leiden University, Leiden, the Netherlands.ORCID 0000-0002-2076-7431
Annemieke van StratenDepartment of Clinical, Neuro- and Developmental Psychology, VU University Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0001-6875-2215
Sascha Yuri StruijsDepartment of Clinical, Neuro- and Developmental Psychology, VU University Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-2668-5410
Julian David KarchDepartment of Methodology and Statistics, Leiden University, Leiden, the Netherlands.ORCID 0000-0002-1625-2822
Philip SpinhovenDepartment of Clinical Psychology, Leiden University, Leiden, the Netherlands.ORCID 0000-0002-4117-335X
Niki AntypaDepartment of Clinical Psychology, Leiden University, Leiden, the Netherlands.ORCID 0000-0001-9343-8842
Caring Universities Consortium

Funding

Dutch Research Council NWA.1292.19.077
6 · The paper itself

Abstract

STUDY

objectivesTo evaluate the effectiveness of a guided digital intervention targeting sleep and circadian rhythms in university students.

methodsWe randomized 195 university students with self-reported insomnia (Insomnia Severity Index ≥10) from nine Dutch Universities to receive either the 5-week guided digital cognitive-behavioral therapy for insomnia "i-Sleep & BioClock", or digital sleep psychoeducation and sleep monitoring. Online assessments were at baseline, 3 (mid-treatment), 6 (post-treatment), and 18 (follow-up) weeks. The primary outcome was insomnia severity at 6 weeks. Secondary outcomes were symptoms of depression and anxiety; functioning; quality of life (QoL); academic performance; and sleep and light exposure diary outcomes.

resultsFrom Nov 1st 2023 until Sept 5th 2024, we randomly assigned 96 students (age 23.8 ± 3.8, 75.4% female) to the intervention and 99 to the control condition, stratified by university and gender. Fifty-one percent completed the post-treatment assessment, and 30% the follow-up. 31% were intervention completers. Linear mixed models showed no significant time x treatment interaction for insomnia severity ("i-Sleep & BioClock": baseline ISI M = 16.8, SD = 4.0; post-treatment ISI M = 10.2, SD = 3.9; Digital psychoeducation: baseline ISI M = 16.5, SD = 3.6; post-treatment ISI M = 11.1, SD = 4.2). The difference in change between groups was -1.17 points (95% CI -2.72 to 0.38), p=.14, Cohen's d = -0.31. Most secondary outcomes showed no significant time x treatment effects.

conclusions"i-Sleep & BioClock" was not more effective than online psychoeducation on most outcomes, possibly due to active elements present in both conditions or low adherence. Future research should identify factors for early disengagement and investigate which intervention components drive improvements in sleep. CLINICAL TRIAL: Effectiveness of a Guided Self-help Intervention for Improving Sleep in University Students, https://clinicaltrials.gov/study/NCT06023693, prospectively registered at ClinicalTrials.gov on August 3rd, 2023.

Indexed as

Cognitive Behavioral TherapyMental HealthSleepSleep Initiation and Maintenance DisordersStudentsAdultFemaleHumansMaleNetherlandsQuality of LifeTreatment OutcomeUniversitiesYoung Adultcircadian rhythmcognitive behavioural therapyE-healthinsomniastudentsuniversity

Identifiers

PMID41288591
PMCPMC13163168

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.