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NCT Number: NCT04069247

Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia

This study aims to conduct a randomized control trial to validate the treatment effect of e-based cognitive behavioral therapy for Insomnia (e-CBT-I) on insomnia disorder, and explore whether e-CBT-I could prevent depression and suicide in youths with insomnia and subclinical depression. In addition, to further explore the mechanisms underlying the association between insomnia treatments and psychiatric disorders, this study will evaluate whether changes in candidate factors including insomnia symptoms, poor sleep hygiene, sleep-related unhelpful thoughts and maladaptive behaviors, circadian rhythm disruption and chronic sleep deprivation will mediate the effect of e-CBT-I on prevention of depression and suicide.

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Key information

Conditions

Insomnia Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Self-Injurious Behavior Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Suicide

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Sixth Hospital, Beijing, China

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About this study

Previous studies have documented the associations of insomnia with depression and suicide. Currently, researchers have done considerable work to investigate whether e-CBT-I could be effective in improving psychological well-being for adults, and previous studies have confirmed that e-CBT-I is effective in reducing depressive symptoms and suicidal ideation in adult population.

However, such studies have not been established in youths yet. Additionally, it is still unclear that by which mechanisms e-CBT-I might affect mental health, and whether e-CBT-I could reduce the risk of depression and suicide.

This study will be the first specifically designed investigation of the preventive effects of e-CBT-I for depression and suicide in youths, and the first large scale causal test of the relationship between insomnia treatments and psychiatric disorders. The results can be expected to influence care provision for the youth population who are at a life stage of emerging adulthood and vulnerable to psychiatric disorders. Further, because the investigators will be using an e-CBT-I approach, a scalable solution may be demonstrated as both feasible and effective. The findings of this study will show the possibility of developing novel preventive intervention for depression and suicide by targeting insomnia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Native Han youths in Hong Kong and mainland China, aged between15-25
  • A diagnosis of insomnia disorder measured by ICD-10 Classification of Mental and Behavioural Disorders
  • The presence of moderate or severe insomnia measured by a score of 15 or above on ISI
  • The presence of subclinical depression assessed by a score of between 4 and 20 on PHQ-9
  • Access to smartphones
  • Ability to read and understand research protocol

Exclusion criteria

  • Shift workers
  • The presence of prominent suicidality (suicide plans and suicide attempts) measured by MINI via telephone interview
  • A reported diagnosis of psychosis, schizophrenia, bipolar disorder, or neurodevelopmental disorders
  • Medical conditions that could cause poor sleep quality and sleep continuity disruption, such as eczema
  • An additional sleep disorder (other than insomnia) that may potentially contribute to a disruption in sleep continuity and quality, such as excessive sleepiness and possible obstructive sleep apnoea
  • The presence of current MDD or a prior episode of MDD within past two months measured by MINI via telephone interview
  • Women during pregnancy or lactation
  • Currently receiving psychological treatment for insomnia provided by a psychologist and/or pharmacological treatment for depression

Treatment and study plan

e-CBT-I

Behavioral

The e-CBT-I will be delivered through a mobile application (eSleep) with a personal password.

e-HE

Behavioral

The e-HE will be delivered in control though a mobile application (eSleep) with a personal password.

Primary outcomes

  1. Number of Participants With Major Depressive Disorder

    Time frame: Up to 12-month follow-up

    Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI).

Secondary outcomes

  1. Change of Depressive Symptoms

    Time frame: Baseline, post-session 2, post-session 4, post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up

    Depressive symptoms will be measured by Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is a commonly used self-administered questionnaire to assess depressive symptoms and severity, with a higher total score suggesting more severe depressive symptoms. Scores range from 0 to 27.

  2. Change of Insomnia Symptoms

    Time frame: Baseline, post-session 2 (week 3/at the conclusion of session 2), post-session 4 (week 5/at the conclusion of session 4), post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up

    Insomnia symptoms will be measured by Insomnia Severity Index (ISI). ISI is a seven-item self-report measure designed to assess the nature, severity and impact of insomnia, with a higher total score suggesting more severe insomnia symptoms. Scores range from 0 to 28.

  3. Percentage of Participants in Remission of Insomnia Disorder

    Time frame: Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up

    Insomnia disorder will be confirmed by International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) Classification of Mental and Behavioural Disorders: Diagnostic Criteria for Research.

Other outcomes

  1. Change of Anxiety Symptoms

    Time frame: Baseline, post-session 2 (week 3/at the conclusion of session 2), post-session 4 (week 5/at the conclusion of session 4), post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up

    Anxiety symptoms will be measured by Generalised Anxiety Disorder 7-item (GAD-7). GAD-7 is a self-report measure of anxiety severity, with a higher total score suggesting more severe anxiety symptoms. Scores range from 0 to 21.

  2. Percentage of Participants With Suicidality

    Time frame: Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up

    Suicidality which includes suicidal ideation, suicide plans and suicide attempts will be measured by MINI.

  3. Change of Suicidal Ideation

    Time frame: Baseline, post-intervention, 6- and 12-month follow-up

    Suicidal ideation will be measured by Beck Scale for Suicide Ideation (BSSI). BSSI is a 19-item self-report measure designed to assess suicidality, with higher total scores representing greater. Scores range from 0 to 38.

  4. Change of Daytime Symptoms

    Time frame: Baseline, post-intervention, 6- and 12-month follow-up

    Daytime symptoms will be measured by Multidimensional Fatigue Inventory (MFI). MFI is a 20-item self-rated scale on fatigue symptoms. There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue. A grand total score can be calculated by summing up the three sub scores. In all cases, a higher score represents higher fatigue symptoms.

  5. Change of Sleep-related Thoughts and Behaviors

    Time frame: Baseline, post-intervention, 6- and 12-month follow-up

    Sleep-related thoughts and behaviors will be measured by Brief Version of Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16). DBAS-16 is a 16-item self-report measure designed to evaluate a subset of those sleep related cognition, with a higher score indicating more dysfunctional beliefs and attitudes about sleep. The total score is calculated from the average score of all the items on the scale and could range from 0 to 10.

  6. Change of Circadian Rhythms

    Time frame: Baseline, post-intervention, 6- and 12-month follow-up

    Circadian rhythms will be measured by reduced version of Horne and Östberg Morningness-Eveningness Questionnaire (rMEQ). The rMEQ is a 5-item self reported measure used to evaluate circadian rhythm and sleep rhythm patterns in individuals. Individuals scored higher than 17 and lower than 12 were classified as morning-type and evening-type, respectively. Individuals scored between 12 and 17 were classified as intermediate-type. Scores range from 4 to 25.

  7. Change of Subjective Sleep Measure (Time in Bed, TIB)

    Time frame: Baseline, post-intervention, 6- and 12-month follow-up

    TIB will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).

  8. Change of Subjective Sleep Measure (Total Sleep Time, TST)

    Time frame: Baseline, post-intervention, 6- and 12-month follow-up

    TST will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).

  9. Change of Subjective Sleep Measure (Sleep Onset Latency, SOL)

    Time frame: Baseline, post-intervention, 6- and 12-month follow-up

    SOL will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).

  10. Change of Subjective Sleep Measure (Wake After Sleep Onset, WASO)

    Time frame: Baseline, post-intervention, 6- and 12-month follow-up

    WASO will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).

  11. Change of Subjective Sleep Measure (Sleep Efficiency, SE)

    Time frame: Baseline, post-intervention, 6- and 12-month follow-up

    SE will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Peking University Sixth Hospital

Registry information

Official study title

Effectiveness of E-based Cognitive Behavioral Therapy for Insomnia on Improving Mental Health in Chinese Youths With Insomnia: a Large-scale Randomized Control Trial

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2019
Registry last updated
Jan 9, 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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