N/A
Completed N=708
Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia
Source: ClinicalTrials.gov NCT04069247 ↗Enrolled (actual)
708
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Number of Participants With Major Depressive Disorder — 37; 62 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Depressive Disorder |
37; 62 | — |
| SECONDARY Change of Depressive Symptoms |
12.1; 12.1; 7.6; 7.7; 6.1; 7.0 | — |
| SECONDARY Change of Insomnia Symptoms |
18.3; 18.3; 11.5; 12.1; 9.0; 10.7 | — |
| SECONDARY Percentage of Participants in Remission of Insomnia Disorder |
52; 28; 56; 44; 57; 48 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT04069247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.