Effectiveness of a Guided Self-help Intervention for Improving Sleep in University Students

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Online Psychoeducation; Behavioral: i-Sleep & BioClock

Study type: Interventional

Funder types: Other

Identifiers

NCT06023693

i-Sleep&BioClockRCT

Details and patient eligibility

About

This randomized controlled trials aims to assess the effectiveness of an online guided self-help intervention ('i-Sleep & BioClock') based on CBTi principles for university students' sleep problems. The study will involve 192 students with subthreshold insomnia who will be randomized to the intervention or online psychoeducation. The intervention consists of 5 modules completed in about 5 weeks, supported by e-coaches. Outcomes include insomnia severity, mental health symptoms, functioning, quality of life, and academic performance, measured at baseline, post-treatment (6 weeks after baseline), and 18 weeks follow-up.

Full description

Rationale: University students often suffer from sleep problems which affect their mental health and daily functioning. Cognitive behavioural therapy for insomnia (CBTi) has been proven effective in adults, but research in university students is still limited. The investigators hypothesize that a guided e-health self-help intervention based on CBTi principles ('i-Sleep & BioClock') could offer convenient treatment to students with sleep problems by reducing insomnia severity and improving mental health outcomes.

Objective: 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, quality of life, and academic performance in university students.

Study design: This is a two-arm parallel group superiority randomized controlled trial, comparing a guided e-health intervention based on CBTi to online psychoeducation (PE).

Study population: The aim is to include 192 university students (Bachelor, Master and PhD) with at least subthreshold insomnia (Insomnia Severity Index ≥ 10), aged ≥ 16, who are able to speak Dutch or English, and are affiliated to one of the nine participating universities. Students with current suicidal ideation are excluded.

Intervention: The intervention will be a guided e-health intervention based on CBTi principles (i-Sleep & BioClock). It consists of 5 modules, to be completed in about 5 weeks, and is aimed at improving sleep in university students. The intervention will be entirely held online and will be supported by e-coaches.

Main study parameters/endpoints: The primary outcome will be insomnia severity. Secondary outcomes will be depression, anxiety, daily functioning, academic performance, quality of life, and sleep & light exposure diary outcomes. Outcomes will be measured at baseline, at post-treatment (6 weeks after baseline), and at 18 weeks follow-up. Mediators such as shift in chronotype and light exposure will be examined at baseline, mid-treatment, and post-treatment

Enrollment: 195 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Being fluent in Dutch and/or English
• Being enrolled as a student (Bachelor, Master or PhD) in one of the Caring Universities partner universities
• Being ≥ 16 years old
• Having self-reported sleep problems; Insomnia Severity Index ≥ 10

Exclusion criteria

• Regular night shifts (Not being able to comply to the intervention due to regular night shift, meaning work between 2AM and 6AM at least once a week)
• Current risk for suicidal behaviour

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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195 participants in 2 patient groups

Guided online self-help intervention

Experimental group

Description:

The intervention will be a guided e-health intervention based on CBTi principles (i-Sleep \& BioClock). It consists of 5 modules, to be completed in about 5 weeks, and is aimed at improving sleep in university students. The intervention will be entirely held online and will be supported by e-coaches. The topics covered will be sleep hygiene, psychoeducation on sleep and the biological clock, sleep restriction, stimulus control, worrying and relaxation, dysfunctional thoughts, and relapse prevention.

Treatment:

Behavioral: i-Sleep & BioClock

Online psychoeducation

Active Comparator group

Description:

The control group will receive access to the platform and to the sleep diary. Their intervention will consist of brief, unstructured online PE for insomnia based on recognized sleep hygiene advice, for example, recommendations about evening routines, and use of alcohol and caffeine. Students will be advised to monitor their sleep in the diary. In contrast to the intervention group, the control group will not receive support of an e-coach. Key differences to the CBTi group are that the online PE (1) does not provide individualized support by an e-coach; (2) includes less content, and (3) is not delivered in a step-by-step manner, but will be provided all at once.

Treatment:

Behavioral: Online Psychoeducation