A study on the effectiveness of a guided e-health sleep and biological clock intervention in university students (i-Sleep & BioClock)

University students often suffer from sleep problems which affect their mood,
energy levels, daily functioning, and quality of life. Irregular sleep-wake
patterns contribute to the disruption of their circadian rhythms. Recent
systematic reviews have found strong associations of insomnia with mental
disorders, such as depression and anxiety. When untreated, persistent insomnia
also increased the risk of suicidal ideation. University students are an
especially vulnerable group as their age group is the most common for the onset
of several mental health disorders, which is why early preventative
interventions are crucial in this population. Although CBTi interventions have
been proven effective in adults, research in university students is still
limited.

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, and quality of life in
university students.

Randomized controlled trial

The *i-Sleep & BioClock* intervention for students is based on the i-Sleep
intervention which was developed by Prof. Annemieke van Straten and Dr. Jaap
Lancee. The intervention was developed based on the existing literature and
uses evidence-based techniques (cognitive behavioural therapy for insomnia). We
adapted i-Sleep to the specific needs of university students and added elements
of the biological clock (e.g. light exposure and timing of exercise and meals).
The new version of the intervention was named i-Sleep & BioClock and it
consists of five modules:

(1) psychoeducation on insomnia, the biological clock, and sleep hygiene,
(2) stimulus control and sleep restriction,
(3) worrying and relaxation,
(4) cognitive therapy to change dysfunctional thoughts about sleep, and
(5) summary module, relapse prevention, and plan for the future.

The modules consist of text, question boxes, exercises, and audio-visual
components (e.g. summary video*s and relaxation audio*s). Each module lasts
about 30 to 60 minutes and it is recommended to complete one module per week.
Therefore, the duration of the i-Sleep & BioClock intervention will be
approximately 5 weeks. In addition, students are asked to keep daily record of
their sleep and light exposure habits in form of a diary.

This study involves a low-risk intervention. Research has shown that
self-guided CBT interventions have a lower rate of negative outcomes on
symptoms than control conditions. We expect the chance of severe incidents
occurring as very unlikely. No adverse events have been reported in a previous
trial examining the effectiveness of i-Sleep among depressed adults with
insomnia. We want to emphasize again that participation is completely voluntary
and participants can always withdraw consent if they feel impaired by the
intervention. Appropriate protocols are in place in case of crisis situations.