Prevention of Insomnia in At-risk Youth

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Insomnia

Treatments: Behavioral: Insomnia prevention program; Behavioral: General health education

Study type: Interventional

Funder types: Other

Identifiers

NCT05451524

2021.005

Details and patient eligibility

About

This study aims to conduct a randomized controlled trial in comparing cognitive behavioral insomnia prevention program with the active control group in youths who are at risk of insomnia. The results of this study will allow us to take this potential efficacious prevention program to scale and reduce the associated burden of insomnia in the future.

Full description

Adolescence is a vulnerable period for the emergence of insomnia, which affects more than 10% of the youths (approximately 40% if based on symptoms). Insomnia in youths tends to run a protracted course and is associated with numerous negative outcomes including poor quality of life, cognitive and academic impairment, and predisposing to development of depression and anxiety. The burden arises from insomnia has been increasingly recognized worldwide as a debilitating and costly public health concern.

However, insomnia in youths is often ignored and under-treated, with only 10% of the local youths recognized their insomnia problem and none of them has received the recommended first-line treatment - cognitive behavioral therapy for insomnia (CBT-I). Given the high prevalence, chronicity and long-lasting health-related consequences of insomnia, together with the delay and limited help-seeking behavior, it calls the urgent need for early insomnia prevention and intervention in this vulnerable population.

Thus, this study aims to conduct a randomized controlled trial in comparing cognitive behavioral insomnia prevention program with the active control group in youths who are at risk of insomnia and to explore the effect of prevention program in preventing the incidence of insomnia problems.

Enrollment: 204 estimated patients

Sex: All

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Youth aged between 15-24 years (as defined by WHO);
• Written informed consent of participation into the study is given by youth and his/her parents if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old;
• Have subclinical insomnia symptoms (at least once a month but less than 3 times/week in the past one month);
• At least one of the biological parents with current or lifetime history of insomnia disorder as defined by DSM-V diagnostic criteria.

Exclusion criteria

• A current or past history of neuropsychiatric disorder(s);
• A prominent medical condition or taking medication with potential side effects that may influence sleep quantity and quality;
• Having a diagnosed sleep disorder that may potentially contribute to the disruption of sleep quantity and quality as ascertained by both Structured Diagnostic Interview for Sleep patterns and Disorders (DISP) such as insomnia, delayed sleep phase and narcolepsy, restless leg syndrome;
• Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
• Currently receiving any structured psychotherapy;
• With hearing or speech deficit;
• Trans-meridian flight in the past 3 months and during the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 2 patient groups

Insomnia prevention program

Experimental group

Description:

The preventive program has been developed and modified as based on the evidence-based CBT-I insomnia treatment. Active intervention group will be conducted in group size with 6-8 subjects who are from the same education level (i.e. secondary vs university). Youths in the intervention group will receive 4 weekly insomnia prevention program conducted by the sleep therapists who has received training in conducting CBT-I under close supervision of sleep experts. Each session will last for about 60-90 mins.

Treatment:

Behavioral: Insomnia prevention program

General health education

Active Comparator group

Description:

In order to control for placebo effect and other non-specific factors such as contact time, youths in the control group will be provided with group-based general health education with same dosage (4 weeks) as intervention group. Modules will contain information about general well-being, diet, nutrition, and activity. It is expected that this health education will be an active control group to account for most of the non-specific effects including time, attention, therapist, and peer support.

Treatment:

Behavioral: General health education