Status:
COMPLETED
Effects of Group-based and Digitally Delivered CBT-I in Youth
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Chinese University of Hong Kong
University of Oxford
Conditions:
Insomnia
Eligibility:
All Genders
12-20 years
Phase:
NA
Brief Summary
Adolescence is a critical transitional stage characterised by a cascade of developmental changes in biological, cognitive, and psychological functioning. Sleep problems, particularly insomnia, are pre...
Eligibility Criteria
Inclusion
- (1) Chinese aged 12-20 years old (an age range that was similarly adopted in the previous studies to cover a wider developmental span in adolescence);
- (2) Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
- (3) Willing to comply with the study protocol;
- (4) Meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria of insomnia disorder and with a score on Insomnia Severity Index (ISI) - 9 (suggested cut-off for adolescents)
Exclusion
- (1) A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities;
- (2) Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
- (3) Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, as ascertained by the Structured Interview for Sleep Patterns and Disorders (DISP), a validated structured diagnostic interview to assess major sleep disorders according to the International Classification of Sleep Disorder (ICSD) criteria;
- (4) Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both western medications (e.g. hypnotics, steroids) and over-the-counter (OTC) medications (e.g. melatonin, Traditional Chinese Medicine, TCM);
- (5) Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
- (6) In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by Mini-International Neuropsychiatric Interview (MINI);
- (7) Currently receiving any structured psychotherapy;
- (8) With hearing or speech deficit; (9) Night shift worker.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT05270369
Start Date
January 1 2022
End Date
November 30 2024
Last Update
April 2 2025
Active Locations (1)
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1
Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong, Hong Kong