Clinical trial NCT04069247: 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
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: cognitive behavioral therapy
insomnia
depression
suicide
youth
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Peking University Sixth Hospital
First posted: 2019-08-28
Enrollment: 708
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Major Depressive Disorder
timeFrame: Up to 12-month follow-up
Secondary outcomes:
measure: Change of Depressive Symptoms
timeFrame: Baseline, post-session 2, post-session 4, post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up
measure: Change of Insomnia Symptoms
timeFrame: 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
measure: Percentage of Participants in Remission of Insomnia Disorder
timeFrame: Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up
Other outcomes:
measure: Change of Anxiety Symptoms
timeFrame: 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
measure: Percentage of Participants With Suicidality
timeFrame: Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up
measure: Change of Suicidal Ideation
timeFrame: Baseline, post-intervention, 6- and 12-month follow-up
measure: Change of Daytime Symptoms
timeFrame: Baseline, post-intervention, 6- and 12-month follow-up
measure: Change of Sleep-related Thoughts and Behaviors
timeFrame: Baseline, post-intervention, 6- and 12-month follow-up
measure: Change of Circadian Rhythms
timeFrame: Baseline, post-intervention, 6- and 12-month follow-up
measure: Change of Subjective Sleep Measure (Time in Bed, TIB)
timeFrame: Baseline, post-intervention, 6- and 12-month follow-up
measure: Change of Subjective Sleep Measure (Total Sleep Time, TST)
timeFrame: Baseline, post-intervention, 6- and 12-month follow-up
measure: Change of Subjective Sleep Measure (Sleep Onset Latency, SOL)
timeFrame: Baseline, post-intervention, 6- and 12-month follow-up
measure: Change of Subjective Sleep Measure (Wake After Sleep Onset, WASO)
timeFrame: Baseline, post-intervention, 6- and 12-month follow-up
measure: Change of Subjective Sleep Measure (Sleep Efficiency, SE)
timeFrame: Baseline, post-intervention, 6- and 12-month follow-up
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital
city: Hong Kong
country: Hong Kong
facility: Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Yun Kwok Wing, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Sixth Hospital
name: Lin Lu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hong Kong University
name: Shirley Xin Li, PhD
role: STUDY_DIRECTOR
affiliation: Chinese University of Hong Kong
name: Jihui Zhang, PhD
role: STUDY_DIRECTOR
affiliation: Peking University Sixth Hospital
name: Le Shi, PhD
role: STUDY_DIRECTOR
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