Clinical trial NCT05451524: Prevention of Insomnia in At-risk Youth
Official title: Prevention of Insomnia in At-risk Youth: A Randomized Controlled Trial Comparing Cognitive Behavioural Prevention Programme for Insomnia With Active Control Condition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: insomnia
prevention
at-risk youth
cognitive behavioral approach
active control group
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 204
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia disorder incidence
timeFrame: week 5
measure: Insomnia disorder incidence
timeFrame: 3-month follow up
measure: Insomnia disorder incidence
timeFrame: 6-month follow up
measure: Insomnia disorder incidence
timeFrame: 12-month follow up
measure: Change of insomnia symptoms
timeFrame: baseline, week 5, 3-, 6-, and 12-month follow up
Secondary outcomes:
measure: Change of sleep parameters as measured by 7-day sleep diary
timeFrame: baseline, week 5, 3-, 6-, and 12-month follow up
measure: Change of score in vulnerability to stress-related insomnia
timeFrame: baseline, week 5, 3-, 6-, and 12-month follow up
measure: Change of sleep-related thoughts and behaviors
timeFrame: baseline, week 5, 3-, 6-, and 12-month follow up
measure: Change of daytime sleepiness
timeFrame: baseline, week 5 3-, 6-, and 12-month follow up
measure: Daytime fatigue
timeFrame: baseline, week 5, 3-, 6-, and 12-month follow up
measure: Change of self-reported cognitive failures
timeFrame: baseline, week 5, 3-, 6-, and 12-month follow up
measure: Change of anxiety and depressive symptoms
timeFrame: baseline, week 5, 3-, 6-, and 12-month follow up
measure: Change of health related quality of life
timeFrame: baseline, week 5, 3-, 6-, and 12-month follow up
measure: Change of sleep hygiene
timeFrame: baseline, week 5, 3-, 6-, and 12-month follow up
measure: Change of pre-sleep arousal behaviors
timeFrame: baseline, week 5, 3-, 6-, and 12-month follow up
measure: Change of academic performance
timeFrame: baseline and 12-month follow up
measure: Change of adolescent's perception and attitude towards sleep
timeFrame: baseline, week 5 3-, 6-, and 12-month follow up
Other outcomes:
measure: Major life events and self-perceived stress
timeFrame: baseline and 12-month follow up
measure: Change of chronotype
timeFrame: baseline, week 5, 3-, 6-, and 12-month follow up
measure: Self-reported pubertal status
timeFrame: baseline and 12-month follow up
measure: Treatment satisfaction, adherence and integrity
timeFrame: week 5
measure: Treatment adherence
timeFrame: week 5
measure: Treatment expectancy and credibility
timeFrame: week 5
Locations:
city: Shatin
country: Hong Kong
facility: Department of Psychiatry
state: NT
Study officials:
affiliation: Chinese University of Hong Kong
name: NGAN YIN CHAN, PhD
role: PRINCIPAL_INVESTIGATOR
References: