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

Primary Purpose

Insomnia

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

ECBT-I

About this trial

This is an interventional prevention trial for Insomnia focused on measuring cognitive behavioral therapy, insomnia, depression, suicide, youth

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 suicide plans and suicide attempts measured by MINI via telephone interview
A reported diagnosis of psychosis, schizophrenia, bipolar disorders, or neurodevelopmental disorders
Medical conditions that could cause poor sleep quality and sleep continuity disruption, such as eczema, gastro-oesophageal and reflux disease
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 major depressive disorder measured by MINI via telephone interview
Women during pregnancy or lactation
Currently receiving psychological treatment for insomnia provided by a psychologist

Sites / Locations

Peking University Sixth HospitalRecruiting
Department of psychiatry, Faculty of Medicine, The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

E-based cognitive behavioral therapy for insomnia (eCBT-I)

Health education (HE)

Arm Description

The eCBT-I will be delivered by a mobile application (eSleep) developed by BestCare & SuMian BioTech Co., Ltd. which contains a digital, self-paced, and highly interactive programme. It consists of six weekly sessions with animated elements, including an overview of sleep, sleep restriction, stimulus control, cognitive therapy, structured worry time and relapse prevention. Participants will have access to the eCBT-I treatment for 12 weeks.

The HE, a psychoeducation/information-approach, also consists of six consecutive sessions which contains information about general sleep knowledge, functions of human organs, nutrition, environmental health, brain health, identification and treatments of common diseases, but the contents are not related to any active therapeutic components of cognitive behavioral therapy for insomnia (CBT-I).Participants will have access to the intervention for 12 weeks.

Outcomes

Primary Outcome Measures

Remission rate 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.

Remission rate of insomnia disorder

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.

New incidence of major depressive disorder

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

New incidence of major depressive disorder

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

New incidence of major depressive disorder

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

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.

Secondary Outcome Measures

New incidence of suicidality

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

New incidence of suicidality

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

New incidence of suicidality

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

Change of anxiety symptoms

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.

Full Information

NCT ID

NCT04069247

First Posted

August 15, 2019

Last Updated

August 28, 2023

Sponsor

Chinese University of Hong Kong

Collaborators

Peking University Sixth Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04069247

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 5, 2019 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

Collaborators

Peking University Sixth Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study aims to conduct a randomized control trial to validate the treatment effect of e-based cognitive behavioral therapy for Insomnia (eCBT-I) on insomnia disorder, and explore whether eCBT-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 eCBT-I on prevention of depression and suicide.

Detailed Description

Previous studies have documented the associations of insomnia with depression and suicide. Currently, researchers have done considerable work to investigate whether eCBT-I could be effective in improving psychological well-being for adults, and previous studies have confirmed that eCBT-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 eCBT-I might affect mental health, and whether eCBT-I could reduce the risk of depression and suicide. This study will be the first specifically designed investigation of the preventive effects of eCBT-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 eCBT-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

Keywords

cognitive behavioral therapy, insomnia, depression, suicide, youth

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

E-based cognitive behavioral therapy for insomnia (eCBT-I)

Arm Type

Experimental

Arm Description

Arm Title

Health education (HE)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

ECBT-I

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Intervention Description

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

Primary Outcome Measure Information:

Title

Remission rate of insomnia disorder

Description

Time Frame

Post-treatment (week 7/at the conclusion of last session)

Title

Remission rate of insomnia disorder

Description

Time Frame

6-month follow-up

Title

Remission rate of insomnia disorder

Description

Time Frame

12-month follow-up

Title

Change of insomnia symptoms

Description

Time Frame

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

Title

New incidence of major depressive disorder

Description

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

Time Frame

Post-treatment (week 7/at the conclusion of last session)

Title

New incidence of major depressive disorder

Description

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

Time Frame

6-month follow-up

Title

New incidence of major depressive disorder

Description

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

Time Frame

12-month follow-up

Title

Change of depressive symptoms

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

New incidence of suicidality

Description

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

Time Frame

Post-treatment (week 7/at the conclusion of last session)

Title

New incidence of suicidality

Description

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

Time Frame

6-month follow-up

Title

New incidence of suicidality

Description

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

Time Frame

12-month follow-up

Title

Change of anxiety symptoms

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Change of suicidal ideation

Description

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.

Time Frame

Baseline, post-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up

Title

Change of daytime symptoms

Description

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.

Time Frame

Baseline, post-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up

Title

Change of sleep-related thoughts and behaviors

Description

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.

Time Frame

Baseline, post-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up

Title

Change of circadian rhythms

Description

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.

Time Frame

Baseline, post-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up

Title

Change of subjective sleep measure (time in bed, TIB)

Description

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).

Time Frame

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

Title

Change of subjective sleep measure (total sleep time, TST)

Description

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).

Time Frame

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

Title

Change of subjective sleep measure (sleep onset latency, SOL)

Description

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).

Time Frame

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

Title

Change of subjective sleep measure (wake after sleep onset, WASO)

Description

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).

Time Frame

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

Title

Change of subjective sleep measure (sleep efficiency, SE)

Description

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).

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 suicide plans and suicide attempts measured by MINI via telephone interview A reported diagnosis of psychosis, schizophrenia, bipolar disorders, or neurodevelopmental disorders Medical conditions that could cause poor sleep quality and sleep continuity disruption, such as eczema, gastro-oesophageal and reflux disease 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 major depressive disorder measured by MINI via telephone interview Women during pregnancy or lactation Currently receiving psychological treatment for insomnia provided by a psychologist

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yun Kwok Wing, MBChB

Phone

+852 39197593

ykwing@cuhk.edu.hk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yun Kwok Wing, MBChB

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lin Lu, PhD

Organizational Affiliation

Peking University Sixth Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shirley Xin Li, PhD

Organizational Affiliation

Hong Kong University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jihui Zhang, PhD

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Le Shi, PhD

Organizational Affiliation

Peking University Sixth Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Peking University Sixth Hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Le Shi, PhD

Facility Name

Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong

City

Hong Kong

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jihui Zhang, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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