Clinical trial NCT05011929: Comparison of the Effects of Support and Non-support Online CBT-I
Official title: Comparison of the Effects of Support and Non-support Online Cognitive Behavioural Therapy for Insomnia in Youth: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2021-08-18
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised, assessor-blind, parallel group controlled trial
Primary purpose: TREATMENT

Brief summary: Insomnia is the most prevalent sleep problem in children and adolescents and it has been found to predict the development of mental health problems in young adulthood. Cognitive behavioral therapy for insomnia (CBT-I) has been found to be effective in both adults and adolescents. However, limited accessibility and availability of the treatment has only benefited a small proportion of insomnia patients. Therefore, digital CBT-I has been promoted as an alternative way to manage individual's insomnia problems with adequate efficacy. Nonetheless, one of the major limitations of the online self-help intervention is the relatively high drop-out rate and lower compliance compared to the face-to-face modality which the interactive component is less practical in the online intervention. Therefore, the objectives of current study are 1) evaluate the efficacy of mobile-APP based CBT-I in treating youth insomnia, 2) evaluate whether the provision of additional support could further enhance the treatment outcomes.


Eligibility criteria: Inclusion Criteria:

* Chinese aged 12-24 years old;
* Informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
* Being able to comply with the study protocol;
* Having a DSM-5 diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) \>= 9 (suggested cut-off for adolescents)

Exclusion Criteria:

* A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities;
* Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
* 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;
* Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);
* In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
* Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
* Initiation of or change in antidepressant medication within past 2 months;
* Having been or is currently receiving any structured psychotherapy;
* With hearing or speech deficit;
* Night shift worker.

Primary outcomes:
measure: Change of insomnia symptoms
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Secondary outcomes:
measure: Change of sleep quality
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of sleep diary measure (total time in bed)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of sleep diary measure (total sleep time)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of sleep diary measure (sleep efficiency)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of sleep diary measure (sleep onset latency)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of sleep diary measure (wake after sleep onset)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of daytime sleepiness
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of daytime fatigue
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of quality of life
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of suicidal ideation
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of self-report mood symptoms
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of dysfunctional beliefs and attitudes about sleep
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of sleep hygiene and practice
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
measure: Change of pre-sleep arousal
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Shirley Xin Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: