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Recruiting NCT05451524

Prevention of Insomnia in At-risk Youth

No phase Interventional Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Insomnia prevention program, General health education.
Who it may be relevant to
Registry conditions: Insomnia. Basic parameters: 15 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Prevention of Insomnia in At-risk Youth: A Randomized Controlled Trial Comparing Cognitive Behavioural Prevention Programme for Insomnia With Active Control Condition

Overview

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.

Interventions

  • Behavioral Insomnia prevention program
    Youths in the intervention group will receive 4 weekly insomnia prevention program. Each session will last for about 60-90 mins.
  • Behavioral General health education
    Youths in the control group will be provided with group-based general health education with same dosage (4 weeks) as intervention group.

Primary outcome measures

  • Insomnia disorder incidence [Time frame: week 5]
  • Insomnia disorder incidence [Time frame: 3-month follow up]
  • Insomnia disorder incidence [Time frame: 6-month follow up]
  • Insomnia disorder incidence [Time frame: 12-month follow up]
  • Change of insomnia symptoms [Time frame: baseline, week 5, 3-, 6-, and 12-month follow up]
Secondary outcome measures (12)
  • Change of sleep parameters as measured by 7-day sleep diary [Time frame: baseline, week 5, 3-, 6-, and 12-month follow up]
  • Change of score in vulnerability to stress-related insomnia [Time frame: baseline, week 5, 3-, 6-, and 12-month follow up]
  • Change of sleep-related thoughts and behaviors [Time frame: baseline, week 5, 3-, 6-, and 12-month follow up]
  • Change of daytime sleepiness [Time frame: baseline, week 5 3-, 6-, and 12-month follow up]
  • Daytime fatigue [Time frame: baseline, week 5, 3-, 6-, and 12-month follow up]
  • Change of self-reported cognitive failures [Time frame: baseline, week 5, 3-, 6-, and 12-month follow up]
  • Change of anxiety and depressive symptoms [Time frame: baseline, week 5, 3-, 6-, and 12-month follow up]
  • Change of health related quality of life [Time frame: baseline, week 5, 3-, 6-, and 12-month follow up]
  • Change of sleep hygiene [Time frame: baseline, week 5, 3-, 6-, and 12-month follow up]
  • Change of pre-sleep arousal behaviors [Time frame: baseline, week 5, 3-, 6-, and 12-month follow up]
  • Change of academic performance [Time frame: baseline and 12-month follow up]
  • Change of adolescent's perception and attitude towards sleep [Time frame: baseline, week 5 3-, 6-, and 12-month follow up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Hong Kong · 1 center
  • Department of Psychiatry — Shatin

Identifiers

NCT: NCT05451524 · 2021.005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗