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

Chinese University of Hong Kong708 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

Eligibility

Sex: ALLMin age: 15 YearsMax age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Native Han youths in Hong Kong and mainland China, aged between15-25 2. A diagnosis of insomnia disorder measured by ICD-10 Classification of Mental and Behavioural Disorders 3. The presence of moderate or severe insomnia measured by a score of 15 or above on ISI 4. The presence of subclinical depression assessed by a score of between 4 and 20 on PHQ-9 5. Access to smartphones 6. Ability to read and understand research protocol Exclusion Criteria: 1. Shift workers 2. The presence of prominent suicidality (suicide plans and suicide attempts) measured by MINI via telephone interview 3. A reported diagnosis of psychosis, schizophrenia, bipolar disorder, or neurodevelopmental disorders 4. Medical conditions that could cause poor sleep quality and sleep continuity disruption, such as eczema 5. 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 6. The presence of current MDD or a prior episode of MDD within past two months measured by MINI via telephone interview 7. Women during pregnancy or lactation 8. Currently receiving psychological treatment for insomnia provided by a psychologist and/or pharmacological treatment for depression

Outcomes

Primary Outcomes

Number of Participants With Major Depressive Disorder

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

Time frame: Up to 12-month follow-up

Secondary Outcomes

Change of Depressive Symptoms

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.

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

Change of Insomnia Symptoms

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.

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

Percentage of Participants in Remission of Insomnia Disorder

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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes