xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06023693</url>
    </required_header>
    <id_info>
      <org_study_id>i-Sleep&amp;BioClockRCT</org_study_id>
      <nct_id>NCT06023693</nct_id>
    </id_info>
    <brief_title>Effectiveness of a Guided Self-help Intervention for Improving Sleep in University Students</brief_title>
    <official_title>A Study on the Effectiveness of a Guided E-health Sleep and Biological Clock Intervention in University Students (i-Sleep &amp; BioClock)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Leiden University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Leiden University Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This randomized controlled trials aims to assess the effectiveness of an online guided&#xD;
        self-help intervention ('i-Sleep &amp; BioClock') based on CBTi principles for university&#xD;
        students' sleep problems. The study will involve 192 students with subthreshold insomnia who&#xD;
        will be randomized to the intervention or online psychoeducation. The intervention consists&#xD;
        of 5 modules completed in about 5 weeks, supported by e-coaches. Outcomes include insomnia&#xD;
        severity, mental health symptoms, functioning, quality of life, and academic performance,&#xD;
        measured at baseline, post-treatment (6 weeks after baseline), and 18 weeks follow-up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rationale: University students often suffer from sleep problems which affect their mental&#xD;
        health and daily functioning. Cognitive behavioural therapy for insomnia (CBTi) has been&#xD;
        proven effective in adults, but research in university students is still limited. The&#xD;
        investigators hypothesize that a guided e-health self-help intervention based on CBTi&#xD;
        principles ('i-Sleep &amp; BioClock') could offer convenient treatment to students with sleep&#xD;
        problems by reducing insomnia severity and improving mental health outcomes.&#xD;
  &#xD;
        Objective: The aim of this randomized controlled trial is to assess the effectiveness of a&#xD;
        guided e-health sleep and biological clock intervention on sleep, mental health symptoms&#xD;
        (depression and anxiety), functioning, quality of life, and academic performance in&#xD;
        university students.&#xD;
  &#xD;
        Study design: This is a two-arm parallel group superiority randomized controlled trial,&#xD;
        comparing a guided e-health intervention based on CBTi to online psychoeducation (PE).&#xD;
  &#xD;
        Study population: The aim is to include 192 university students (Bachelor, Master and PhD)&#xD;
        with at least subthreshold insomnia (Insomnia Severity Index ≥ 10), aged ≥ 16, who are able&#xD;
        to speak Dutch or English, and are affiliated to one of the nine participating universities.&#xD;
        Students with current suicidal ideation are excluded.&#xD;
  &#xD;
        Intervention: The intervention will be a guided e-health intervention based on CBTi&#xD;
        principles (i-Sleep &amp; BioClock). It consists of 5 modules, to be completed in about 5 weeks,&#xD;
        and is aimed at improving sleep in university students. The intervention will be entirely&#xD;
        held online and will be supported by e-coaches.&#xD;
  &#xD;
        Main study parameters/endpoints: The primary outcome will be insomnia severity. Secondary&#xD;
        outcomes will be depression, anxiety, daily functioning, academic performance, quality of&#xD;
        life, and sleep &amp; light exposure diary outcomes. Outcomes will be measured at baseline, at&#xD;
        post-treatment (6 weeks after baseline), and at 18 weeks follow-up. Mediators such as shift&#xD;
        in chronotype and light exposure will be examined at baseline, mid-treatment, and&#xD;
        post-treatment&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Insomnia Severity Index</measure>
      <time_frame>Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)</time_frame>
      <description>7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep efficiency (in minutes)</measure>
      <time_frame>Change from week 1 to week 7</time_frame>
      <description>Derived from sleep and light exposure diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep onset latency (in minutes)</measure>
      <time_frame>Change from week 1 to week 7</time_frame>
      <description>Derived from sleep and light exposure diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wake after sleep onset (in minutes)</measure>
      <time_frame>Change from week 1 to week 7</time_frame>
      <description>Derived from sleep and light exposure diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Early morning awakening (in minutes)</measure>
      <time_frame>Change from week 1 to week 7</time_frame>
      <description>Derived from sleep and light exposure diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total sleep time (in minutes)</measure>
      <time_frame>Change from week 1 to week 7</time_frame>
      <description>Derived from sleep and light exposure diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time spent outside (in minutes)</measure>
      <time_frame>Change from week 1 to week 7</time_frame>
      <description>Derived from sleep and light exposure diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Screen use before bed</measure>
      <time_frame>Change from week 1 to week 7</time_frame>
      <description>Yes/ No question. Derived from sleep and light exposure diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Munich Chronotype Questionnaire (MCTQ)</measure>
      <time_frame>Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-9)</measure>
      <time_frame>Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)</time_frame>
      <description>9-items self-report instrument for severity of depressive symptoms, scores ranging from 0-27, higher scores indicating more severe depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalised Anxiety Disorder scale (GAD-7)</measure>
      <time_frame>Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)</time_frame>
      <description>7-items self-report instrument for severity of anxiety symptoms, scores ranging from 0-21, higher scores indicating more severe anxiety</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Work and Social Adjustment Scale (WSAS)</measure>
      <time_frame>Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)</time_frame>
      <description>5-item self-report instrument for impairment of functioning, scores ranging from 0-40, higher scores indicating more impairment in functioning</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mental Health Quality of Life questionnaire (MHQoL)</measure>
      <time_frame>Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dysfunctional beliefs and attitudes about sleep (DBAS-10)</measure>
      <time_frame>Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)</time_frame>
      <description>10-item abbreviated measure for dysfunctional beliefs and attitudes about sleep, scored on a scale from 0 (strongly disagree) to 10 (strongly agree)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pre-Sleep Arousal Scale (PSAS)</measure>
      <time_frame>Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)</time_frame>
      <description>16-item self report instrument for pre-sleep arousal, 5-point Likert Scale, higher scores reflecting more arousal</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Academic performance</measure>
      <time_frame>Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Adherence - Total number of completed modules</measure>
      <time_frame>Through study completion, an average of 18 weeks</time_frame>
      <description>Measures though Log Data</description>
    </other_outcome>
    <other_outcome>
      <measure>Adherence - Time spent in the platform (in minutes)</measure>
      <time_frame>Through study completion, an average of 18 weeks</time_frame>
      <description>Measures though Log Data</description>
    </other_outcome>
    <other_outcome>
      <measure>Adherence - Number of logins (total amount)</measure>
      <time_frame>Through study completion, an average of 18 weeks</time_frame>
      <description>Measures though Log Data</description>
    </other_outcome>
    <other_outcome>
      <measure>Adverse events</measure>
      <time_frame>Mid-treatment (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)</time_frame>
      <description>1) falling accidents, 2) traffic accidents, or 3) any other accidents related to fatigue or sleepiness, and its consequences</description>
    </other_outcome>
    <other_outcome>
      <measure>Stressful life events questionnaire</measure>
      <time_frame>Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)</time_frame>
      <description>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</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">192</enrollment>
    <condition>Insomnia</condition>
    <arm_group>
      <arm_group_label>Guided online self-help intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention will be a guided e-health intervention based on CBTi principles (i-Sleep &amp; 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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Online psychoeducation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>i-Sleep &amp; BioClock</intervention_name>
      <description>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</description>
      <arm_group_label>Guided online self-help intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Online Psychoeducation</intervention_name>
      <description>Online psychoeducation about sleep and the biological clock, basic sleep hygiene</description>
      <arm_group_label>Online psychoeducation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being fluent in Dutch and/or English&#xD;
  &#xD;
            -  Being enrolled as a student (Bachelor, Master or PhD) in one of the Caring&#xD;
               Universities partner universities&#xD;
  &#xD;
            -  Being ≥ 16 years old&#xD;
  &#xD;
            -  Having self-reported sleep problems; Insomnia Severity Index ≥ 10&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Regular night shifts (Not being able to comply to the intervention due to regular&#xD;
               night shift, meaning work between 2AM and 6AM at least once a week)&#xD;
  &#xD;
            -  Current risk for suicidal behaviour&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Niki Antypa, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Leiden University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Laura Pape, MSc.</last_name>
      <phone>+31 71 527</phone>
      <phone_ext>1780</phone_ext>
      <email>l.m.pape@fsw.leidenuniv.nl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Leiden Univeristy</name>
        <address>
          <city>Leiden</city>
          <zip>2333AK</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <last_name>Laura Pape</last_name>
        <email>l.m.pape@fsw.leidenuniv.nl</email>
      </contact>
      <contact_backup>
        <last_name>Niki Antypa</last_name>
        <email>nantypa@fsw.leidenuniv.nl</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
      <investigator_full_name>Philip Spinhoven</investigator_full_name>
      <investigator_title>Prof. dr. Philip Spinhoven</investigator_title>
    </responsible_party>
    <keyword>sleep</keyword>
    <keyword>guided self-help</keyword>
    <keyword>CBTi</keyword>
    <keyword>e-health</keyword>
    <keyword>university students</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06023693
  org study id: i-Sleep&BioClockRCT
  nct id: NCT06023693
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Insomnia Severity Index
  time frame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
  description: 7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity
  measure: Sleep efficiency (in minutes)
  time frame: Change from week 1 to week 7
  description: Derived from sleep and light exposure diary
  measure: Sleep onset latency (in minutes)
  time frame: Change from week 1 to week 7
  description: Derived from sleep and light exposure diary
  measure: Wake after sleep onset (in minutes)
  time frame: Change from week 1 to week 7
  description: Derived from sleep and light exposure diary
  measure: Early morning awakening (in minutes)
  time frame: Change from week 1 to week 7
  description: Derived from sleep and light exposure diary
  measure: Total sleep time (in minutes)
  time frame: Change from week 1 to week 7
  description: Derived from sleep and light exposure diary
  measure: Time spent outside (in minutes)
  time frame: Change from week 1 to week 7
  description: Derived from sleep and light exposure diary
  measure: Screen use before bed
  time frame: Change from week 1 to week 7
  description: Yes/ No question. Derived from sleep and light exposure diary
  measure: Munich Chronotype Questionnaire (MCTQ)
  time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
  description: 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.
  measure: Patient Health Questionnaire (PHQ-9)
  time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
  description: 9-items self-report instrument for severity of depressive symptoms, scores ranging from 0-27, higher scores indicating more severe depression
  measure: Generalised Anxiety Disorder scale (GAD-7)
  time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
  description: 7-items self-report instrument for severity of anxiety symptoms, scores ranging from 0-21, higher scores indicating more severe anxiety
  measure: Work and Social Adjustment Scale (WSAS)
  time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
  description: 5-item self-report instrument for impairment of functioning, scores ranging from 0-40, higher scores indicating more impairment in functioning
  measure: Mental Health Quality of Life questionnaire (MHQoL)
  time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
  description: 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)
  measure: Dysfunctional beliefs and attitudes about sleep (DBAS-10)
  time frame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)
  description: 10-item abbreviated measure for dysfunctional beliefs and attitudes about sleep, scored on a scale from 0 (strongly disagree) to 10 (strongly agree)
  measure: Pre-Sleep Arousal Scale (PSAS)
  time frame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)
  description: 16-item self report instrument for pre-sleep arousal, 5-point Likert Scale, higher scores reflecting more arousal
  measure: Academic performance
  time frame: Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
  description: 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)
  measure: Adherence - Total number of completed modules
  time frame: Through study completion, an average of 18 weeks
  description: Measures though Log Data
  measure: Adherence - Time spent in the platform (in minutes)
  time frame: Through study completion, an average of 18 weeks
  description: Measures though Log Data
  measure: Adherence - Number of logins (total amount)
  time frame: Through study completion, an average of 18 weeks
  description: Measures though Log Data
  measure: Adverse events
  time frame: Mid-treatment (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
  description: 1) falling accidents, 2) traffic accidents, or 3) any other accidents related to fatigue or sleepiness, and its consequences
  measure: Stressful life events questionnaire
  time frame: Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
  description: 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
  arm group label: Guided online self-help intervention
  arm group type: Experimental
  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.
  arm group label: Online psychoeducation
  arm group type: Active Comparator
  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.
  intervention type: Behavioral
  intervention name: i-Sleep & BioClock
  description: 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
  arm group label: Guided online self-help intervention
  intervention type: Behavioral
  intervention name: Online Psychoeducation
  description: Online psychoeducation about sleep and the biological clock, basic sleep hygiene
  arm group label: Online psychoeducation
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Niki Antypa, Dr.
  role: Principal Investigator
  affiliation: Leiden University
  last name: Laura Pape, MSc.
  phone: +31 71 527
  phone ext: 1780
  email: l.m.pape@fsw.leidenuniv.nl
  facility: 
  contact: 
  contact backup: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Leiden University Medical Center
  investigator full name: Philip Spinhoven
  investigator title: Prof. dr. Philip Spinhoven
  sharing ipd: No