Clinical trial NCT06023693: Effectiveness of a Guided Self-help Intervention for Improving Sleep in University Students
Official title: A Study on the Effectiveness of a Guided E-health Sleep and Biological Clock Intervention in University Students (i-Sleep & BioClock)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: sleep
guided self-help
CBTi
e-health
university students
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 195
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Secondary outcomes:
measure: Sleep efficiency (in minutes)
timeFrame: Change from week 1 to week 7
measure: Sleep onset latency (in minutes)
timeFrame: Change from week 1 to week 7
measure: Wake after sleep onset (in minutes)
timeFrame: Change from week 1 to week 7
measure: Early morning awakening (in minutes)
timeFrame: Change from week 1 to week 7
measure: Total sleep time (in minutes)
timeFrame: Change from week 1 to week 7
measure: Time spent outside (in minutes)
timeFrame: Change from week 1 to week 7
measure: Screen use before bed
timeFrame: Change from week 1 to week 7
measure: Munich Chronotype Questionnaire (MCTQ)
timeFrame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
measure: Generalised Anxiety Disorder scale (GAD-7)
timeFrame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
measure: Mental Health Quality of Life questionnaire (MHQoL)
timeFrame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
measure: Dysfunctional beliefs and attitudes about sleep (DBAS-10)
timeFrame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)
measure: Pre-Sleep Arousal Scale (PSAS)
timeFrame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)
measure: Academic performance
timeFrame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Other outcomes:
measure: Adherence - Total number of completed modules
timeFrame: Through study completion, an average of 18 weeks
measure: Adherence - Time spent in the platform (in minutes)
timeFrame: Through study completion, an average of 18 weeks
measure: Adherence - Number of logins (total amount)
timeFrame: Through study completion, an average of 18 weeks
measure: Adverse events
timeFrame: Mid-treatment (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
measure: Stressful life events questionnaire
timeFrame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Locations:
city: Leiden
country: Netherlands
facility: Leiden Univeristy
Study officials:
affiliation: Leiden University
name: Niki Antypa, Dr.
role: PRINCIPAL_INVESTIGATOR
References: