Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00447

2 Trial Registration Date

2015-02-11

i Registration Status

Prospective

3 Secondary IDs

CRE-2012.576-T

4 Source(s) of Funding

Research Grants Council-General Research Fund

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Mandy Yu

ii Address

Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Shan

iii Phone

39797593

iv Email

mandyyu@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Wing Yun Kwok

ii Address

Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Shan

iii Phone

39797593

iv Email

ykwing@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

China

9 Official Scientific Title of the Study

Can we prevent insomnia? A randomized controlled trial of brief cognitive-behavioral insomnia prevention program for high-risk adolescents

10 Public Title

Can we prevent insomnia? A randomized controlled trial of brief cognitive-behavioral insomnia prevention program for high-risk adolescents

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

Brief CBT-I prevention programme for high risk adolescents

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-01-19

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2012.576-T

14 Medical Condition Being Studied

Insomnia

15 Intervention

i Types of intervention

Other

Please specify

Cognitive-behavioral therapy

ii Description/ name of Intervention/article

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.

iii Dosage form of the intervention

group therapy

iv Dosage of the intervention

4 sessions

v Duration of the intervention

4 weeks

vi Frequency of the intervention

weekly

16 Comparative Treatments

i Description/ name of comparative treatments

control group with no active intervention

ii Dosage form of the comparative treatments

no active intervention

iii Dosage of the comparative treatments

no active intervention

iv Duration of the comparative treatments

no active intervention

v Frequency of the comparative treatments

no active intervention

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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].

ii Exclusion Criteria

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)

iii Age Minimum

12

iv Age Maximum

18

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

randomization

ii Nature of control

Not Applicable

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

na

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-03-01

21 Target Sample Size

250

22 Recruitment Status

Recruiting

23 Primary Outcome

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, and 18 month after the interventional trial.

24 Secondary Outcome

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 and 18 month after the interventional trial.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-08-21

27 Primary Registry and Trial Identifying Number

ChiCTR-IPC-15005966

28 Date of Registration in Primary Registry

2015-02-12

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Trial History Detail on 2019-03-15