Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPC-15005966
Enrollment
Unknown
Registered
2015-02-11
Start date
2015-03-01
Completion date
Unknown
Last updated
2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

Two groups:Cognitive-behavioral therapy for four weeks versus no active intervention

Sponsors

The Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Chinese aged 12-18 years old; 2. Written informed consent of participation into the study is given by his/her parents or caregivers; 3. Being able to comply with the study protocol; 4. 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; 5. 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].

Exclusion criteria

Exclusion criteria: 1. A current or past history of psychiatric disorder(s) or neurodevelopmental disorder(s); 2. Receiving a medication known to affect sleep continuity and quality (e.g. psychotropics); 3. Having a prominent medical condition known to interfere with sleep continuity and quality(e.g. Eczema, Gastric acid reflux); 4. 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).

Design outcomes

Primary

MeasureTime frame
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.;

Secondary

MeasureTime frame
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.;

Countries

China

Contacts

Public ContactProf. Wing Yun Kwok
ykwing@cuhk.edu.hk+852 26367748

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026