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

Clinical Snapshot

Key Findings

• P Value: p = 0.14

• Effect Size: Cohen's d = -0.31 (small effect favouring intervention)

• Primary Outcome: No significant difference in insomnia severity between groups at 6 weeks

• Nnt Or Sensitivity: Not applicable - no significant benefit demonstrated

• Confidence Interval: 95% CI -2.72 to 0.38 points on ISI

Clinical Application

Low feasibility given poor adherence (31% completion) and high dropout rates in motivated research participants Relevant to Australian university mental health services, though PBS funding unlikely given lack of efficacy. May inform university counselling services about digital CBT-I limitations University students with mild to moderate insomnia seeking digital health interventions

Abstract

STUDY OBJECTIVES: To evaluate the effectiveness of a guided digital intervention targeting sleep and circadian rhythms in university students. METHODS: We 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. RESULTS: From 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.

References

1. 1.Pape, L. M., van Straten, A., Struijs, S. Y., Karch, J. D., Spinhoven, P., & Antypa, N. (2026). Effects of a guided digital intervention on sleep and mental health outcomes in university students - a randomized controlled trial. Sleep. https://doi.org/10.1093/sleep/zsaf357