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Completed

NCT Number: NCT06023693

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

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden Univeristy

Leiden, 2333AK, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

i-Sleep & BioClock

Behavioral

Module 1 Psychoeducation about normal sleep and insomnia, Psychoeducation on the biological clock: the circadian rhythm, chronotypes, zeitgebers, importance of light behaviour Basic sleep hygiene: information about behaviours that are known to promote or impede sleep e.g. performing physical exercise or the use of caffeine Module 2 Sleep restriction and stimulus control: patients are taught to use the bedroom only to sleep and to restrict the time in bed to the average amount of night-time sleep Module 3 Worrying and relaxation: audio files with progressive muscle relaxation exercises are offered and techniques to stop worrying (e.g. thought blocking, evaluation and worry time) Module 4 Erroneous cognitions about sleep: the basics of cognitive behavioural therapy are explained and the most common erroneous ideas about insomnia are discussed Module 5 Summary and plan for the future

online psychoeducation

Behavioral

Online psychoeducation about sleep and the biological clock, basic sleep hygiene

Primary outcomes

  1. Insomnia Severity Index

    Time frame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)

    7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity

Secondary outcomes

  1. Sleep efficiency (in minutes)

    Time frame: Change from week 1 to week 7

    Derived from sleep and light exposure diary

  2. Sleep onset latency (in minutes)

    Time frame: Change from week 1 to week 7

    Derived from sleep and light exposure diary

  3. Wake after sleep onset (in minutes)

    Time frame: Change from week 1 to week 7

    Derived from sleep and light exposure diary

  4. Early morning awakening (in minutes)

    Time frame: Change from week 1 to week 7

    Derived from sleep and light exposure diary

  5. Total sleep time (in minutes)

    Time frame: Change from week 1 to week 7

    Derived from sleep and light exposure diary

  6. Time spent outside (in minutes)

    Time frame: Change from week 1 to week 7

    Derived from sleep and light exposure diary

  7. Screen use before bed

    Time frame: Change from week 1 to week 7

    Yes/ No question. Derived from sleep and light exposure diary

  8. Munich Chronotype Questionnaire (MCTQ)

    Time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)

    Self-rated scale to assess individual phase of entrainment on work and work-free days, Addresses questions about: bedtime (actual time), time spent in bed awake before deciding to turn off the lights (in minutes), how long it takes to fall asleep (in minutes), wake up time (actual time), get up time (actual time) on work and work-free days. MCTQ uses the midpoint between sleep on- and offset on free days (mid-sleep on free days, MSF) to assess chronotype. The MCTQ chronotype is expressed in local time, in which earlier time refers to earlier chronotype and later time to later chronotype.

  9. Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)

    9-items self-report instrument for severity of depressive symptoms, scores ranging from 0-27, higher scores indicating more severe depression

  10. Generalised Anxiety Disorder scale (GAD-7)

    Time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)

    7-items self-report instrument for severity of anxiety symptoms, scores ranging from 0-21, higher scores indicating more severe anxiety

  11. Work and Social Adjustment Scale (WSAS)

    Time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)

    5-item self-report instrument for impairment of functioning, scores ranging from 0-40, higher scores indicating more impairment in functioning

  12. Mental Health Quality of Life questionnaire (MHQoL)

    Time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)

    7-item self report instrument for quality of life measure for use in people with mental health problems, scores ranging from 0-21, higher scores indicating higher quality of life, and MHQoL-VAS visual scale ranging from 0 (worst imaginable psychological wellbeing) to 10 (best imaginable psychological wellbeing)

  13. Dysfunctional beliefs and attitudes about sleep (DBAS-10)

    Time frame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)

    10-item abbreviated measure for dysfunctional beliefs and attitudes about sleep, scored on a scale from 0 (strongly disagree) to 10 (strongly agree)

  14. Pre-Sleep Arousal Scale (PSAS)

    Time frame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)

    16-item self report instrument for pre-sleep arousal, 5-point Likert Scale, higher scores reflecting more arousal

  15. Academic performance

    Time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)

    Students will be asked about the grade of their last exam (Scale 1-10), the average grade of the past semester (Scale 1-10), whether they failed any exams in the past semester (Yes/No), and their study progression in the past semester in terms of ECTS achieved (30 ECTS per semester, Yes/No)

Other outcomes

  1. Adherence - Total number of completed modules

    Time frame: Through study completion, an average of 18 weeks

    Measures though Log Data

  2. Adherence - Time spent in the platform (in minutes)

    Time frame: Through study completion, an average of 18 weeks

    Measures though Log Data

  3. Adherence - Number of logins (total amount)

    Time frame: Through study completion, an average of 18 weeks

    Measures though Log Data

  4. Adverse events

    Time frame: Mid-treatment (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)

    • falling accidents, 2) traffic accidents, or 3) any other accidents related to fatigue or sleepiness, and its consequences

  5. Stressful life events questionnaire

    Time frame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)

    2 item questionnaire about whether participants experienced life-threatening or serious accident/ illness, death of someone close, physical/sexual violence or abuse or other incidents, and the consequences thereof

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

A Study on the Effectiveness of a Guided E-health Sleep and Biological Clock Intervention in University Students (i-Sleep & BioClock)

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 5, 2023
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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