CUHK_CCT00447
2015-02-11
Prospective
CRE-2012.576-T
Research Grants Council-General Research Fund
The Chinese University of Hong Kong
NA
Not Applicable
Mandy Yu
Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Shan
39797593
mandyyu@cuhk.edu.hk
The Chinese University of Hong Kong
Hong Kong
Prof. Wing Yun Kwok
Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Shan
39797593
ykwing@cuhk.edu.hk
The Chinese University of Hong Kong
China
Can we prevent insomnia? A randomized controlled trial of brief cognitive-behavioral insomnia prevention program for high-risk adolescents
Can we prevent insomnia? A randomized controlled trial of brief cognitive-behavioral insomnia prevention program for high-risk adolescents
失眠可以預防嗎? 針對高危青少年預防失眠的隨機對照認知行為計劃
Brief CBT-I prevention programme for high risk adolescents
Hong Kong
Yes
2013-01-19
Joint CUHK-NTEC Clinical Research Ethics Committee
CRE-2012.576-T
Insomnia
Other
Cognitive-behavioral therapy
The structure and content of the active preventive program will be developed and adapted by the research team comprising of sleep medicine specialists and experienced clinical psychologists on the basis of previous research on cognitive behavioral therapy for insomnia management. In particularly, the program will feature behavioral, cognitive and educational components that target the potentially modifiable risk factors in the insomnia etiology.
group therapy
4 sessions
4 weeks
weekly
control group with no active intervention
no active intervention
no active intervention
no active intervention
no active intervention
i. Chinese aged 12-18 years old;
ii. Written informed consent of participation into the study is given by his/her parents or caregivers;
iii. Being able to comply with the study protocol;
iv. Having at least one of the biological parents (either mother or father) reporting lifetime history or current insomnia disorder as defined by DSM-V (Having >/= 3 times of DIS, DMS, or EMA for 3 months, with significant distress or impairment of daytime functioning;
v. Reporting sub-threshold insomnia symptoms [having sleep difficulty in one of the following domains at least once per month but less than three times per week in the past one month: DIS, DMS, or EMA].
i. A current or past history of psychiatric disorder(s) or neurodevelopmental disorder(s);
ii. Receiving a medication known to affect sleep continuity and quality (e.g. psychotropics);
iii. Having a prominent medical condition known to interfere with sleep continuity and quality(e.g. Eczema, Gastric acid reflux);
iv. 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 Diagnostic Interview for Sleep Patterns and Disorders (DISP)
12
18
Both Male and Female
Interventional
Randomized
randomization
Not Applicable
Single-blind
Investigator/research team
Parallel
Other
na
2015-03-01
250
Complete
1. Incidence of insomnia disorder as confirmed by a clinical diagnosis of insomnia disorder based on DSM-V criteria; 2. The severity of insomnia symptoms as measured by Insomnia Severity Index (ISI)
All primary outcomes will be measured at baseline and reassessed at 2-week, 6-month, 12 month, 18 month, 24month, 36month and 48 month after the interventional trial.
sleep related measures including PDSS (daytime sleepiness scale), DBAS(sleep belief), FIRST(vulnerability to stress-related insomnia), ASHS(Adolescent Sleep Hygiene Practice), MEQ(Morningness and eveningness questionnaire), sleep diary, actiwatch and salivary cortisol. Mental health and fatigue will be measured by HADS, MFI and Kidscreen-27. All the secondary outcomes (except actiwatch and salivary cortisol) will be measured at baseline and reassessed at 2-week, 6-month, 12 month, 18 month 24month, 36month and 48 month after the interventional trial.
2020-08-21
ChiCTR-IPC-15005966
2015-02-12
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