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

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

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.

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.

"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.

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.