Comparison of the Effects of Support and Non-support Online CBT-I

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of the Effects of Support and Non-support Online Cognitive Behavioural Therapy for Insomnia in Youth: a Randomised Controlled Trial

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomised, assessor-blind, parallel group controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: online CBT-I with support (individualized feedback and reminders)<br>The mobile-APP based CBT-I consists of 6 weekly session. The treatment is structured and based on the well-established CBT elements for treating insomnia. The treatment components in the CBT-I aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia and include: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention. reminders and individualized feedback regarding the behavioral strategies will be sent to the participant every week. | Behavioral: Cognitive behavioral therapy<br>* refer to the arm description<br>|
| Active Comparator: online CBT-I without support<br>same as the experimental arm but without reminders and individualized feedback | Behavioral: Cognitive behavioral therapy<br>* refer to the arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of insomnia symptoms | Insomnia Severity Index (ISI) is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of sleep quality | Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale consisting of 19 questions. All items are combined to form seven component scores on different aspects of sleep quality, each of which ranges from 0 to 3 points with higher scores representing more sleep disturbance. The seven component scores are added to one global score, which ranges from 0 to 21, with higher scores indicating more difficulties with sleep. | 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 | 
| Change of sleep diary measure (total time in bed) | Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total time in bed (minutes) | 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 | 
| Change of sleep diary measure (total sleep time) | Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (minutes) | 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 | 
| Change of sleep diary measure (sleep efficiency) | Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep efficiency (%) | 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 | 
| Change of sleep diary measure (sleep onset latency) | Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (minutes) | 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 | 
| Change of sleep diary measure (wake after sleep onset) | Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (minutes). | 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 | 
| Change of daytime sleepiness | Paediatric Daytime Sleepiness Scale (PDSS) is an 8-item self-rated scale measuring daytime sleepiness, ranging in total scores from 0 to 32 with higher scores indicating more sleepiness. | 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 | 
| Change of daytime fatigue | Multidimensional Fatigue Inventory (MFI) is a 20-item self-rated scale on fatigue symptoms. There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue. A grand total score can be calculated by summing up the three sub scores. In all cases, a higher score represents higher fatigue symptoms. | 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 | 
| Change of quality of life | KIDSCREEN-27 is a 27-item self-rated scale measuring health related quality of life measure for children and adolescents. There are five subscales on: physical well-being (possibly scored from 5 to 25), psychological well-being (possibly scored 7 to 35), autonomy & parents (possibly scored 7 to 35), peers & social support (possibly scored 4 to 20), and school environment (possibly scored 4 to 20). A grand total score can be calculated by summing up the five sub scores. In all cases, a higher score represents higher perceived well-being. | 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 | 
| Change of suicidal ideation | Depressive Symptom Inventory Suicidality Subscale (DSI-SS) is a 4-item self-rated scale measuring suicidal ideation. Possible total scores range from 0 to 12, with higher scores indicating higher suicidal ideation. | 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 | 
| Change of self-report mood symptoms | Hospital Anxiety and Depression Scale (HADS) is a self-assessed scale for detecting states of depression and anxiety. The depression subscale range in scores from 0 to 21, with higher scores indicating severer states of depression. Similarly, the anxiety subscale range in scores from 0-21 with higher scores indicating severer states of anxiety. No additional computation will be made with the two subscores | 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 | 
| Change of dysfunctional beliefs and attitudes about sleep | Dysfunctional Beliefs and Attitudes about Sleep (DBAS) is a 16-item self-rated scale measuring the respondent's sleep-related beliefs, more specifically, their expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues. A total score is calculated by averaging score of all items, possibly scored 0 to 10, with a higher score indicating more dysfunctional beliefs and attitudes about sleep. | 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 | 
| Change of sleep hygiene and practice | Sleep Hygiene Practice Scale (SHPS) is a 30-item self-rated scale measuring sleep hygiene behaviors, ranging in total scores from 30 to 180, with higher scores indicating lower levels of sleep hygiene. | 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 | 
| Change of pre-sleep arousal | Pre-Sleep Arousal Scale is a 16-item self-rated scale measuring pre-sleep arousal. There are two subscales on the cognitive and somatic manifestations of arousal, with eight items in each subscale (possibly scored from 8 to 40). In both cases, a higher score indicates higher pre-sleep arousal. | 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 |