Effects of Self-help Versus Group Cognitive Behavioural Therapy for Insomnia in Youth

Study Overview
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Brief Summary
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Insomnia is the most prevalent sleep problem in both the general and clinical populations. Insomnia symptoms, presented as the problems initiating sleep or maintaining sleep, have been reported in association with adverse outcomes in adolescents, including an increased risk of developing depression, anxiety, interpersonal problems, somatic health problems, self-harm and suicidal ideation. Moreover, adolescent insomnia has been found to predict the development of mental health problems in young adulthood. Currently there is no medication specifically approved for use as hypnotics in children under age 18 by the US Food and Drug Administration (FDA). Although cognitive behavioural therapy for insomnia (CBT-I) has been regarded as the first-line treatment for insomnia in adults, there exists limited evidence for the efficacy of CBT-I among adolescents and young adults. Given the high prevalence and profound consequences of insomnia among youth, further research on the short-term and long-term effects of CBT-I for adolescents is warranted. To address the limitations of the existing literature, this randomised controlled trial aims to examine whether face-to-face (group-based CBT-I) versus self-help insomnia treatment benefit adolescents with insomnia, for improving sleep and other clinical and daytime symptoms as well as overall functional improvement in both the short and long term.

Official Title
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Effects of Self-help Versus Group Cognitive Behavioural Therapy for Insomnia in Youth: a Randomised Controlled Trial

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: CBTI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese aged 12-24 years old (according to World Health Organization's defined age range for youth); Written 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 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, as ascertained by the Diagnostic Interview for Sleep Patterns and Disorders (DISP); 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group CBTI<br>Behavioral: Cognitive Behavioural Therapy for Insomnia (CBT-I) The intervention will consist of 8 weekly group sessions (90-min, 5-8 adolescents in each group) of CBT-I delivered within a 10-week window. 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. | Behavioral: CBTI<br>* Refer to the arm description<br>|
| Active Comparator: Email-delivered CBTI<br>The email delivered self-guided CBT-I consists of 8 weekly learning sessions. Participants will receive an email embedded with session materials each week. | Behavioral: CBTI<br>* Refer to the arm description<br>|
| No Intervention: Waiting-list control<br>Participants will not receive any active treatment. | |

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 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month 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 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups | 
| Change of sleep diary measure (time in bed, TIB) | Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: time in bed (TIB) in hours | Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups] | 
| Change of sleep diary measure (total sleep time, TST) | Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours | Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups | 
| Change of sleep diary measure (sleep onset latency, SOL) | Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (SOL) in mins | Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups] | 
| Change of sleep diary measure (wake after sleep onset, WASO) | Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (WASO) in mins | Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups | 
| Change of sleep diary measure (sleep efficiency, SE) | Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, % | Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups | 
| Change of objective sleep measure (time in bed, TIB) | Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: time in bed (TIB) in hours | Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups | 
| Change of objective sleep measure (total sleep time, TST) | Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: total sleep time (TST) in hours | Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups | 
| Change of objective sleep measure (sleep onset latency, SOL) | Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep onset latency (SOL) in mins | Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups | 
| Change of objective sleep measure (wake after sleep onset, WASO) | Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: wake after sleep onset (WASO) in mins | Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-month 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 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month 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 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month 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 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month 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 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month 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 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month 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 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month 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 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month 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 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups] | 
| Change of depressive symptoms (assessor-rated) | Hamilton Depression Rating Scale (HAM-D): 17 item for assessing depression | Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups | 
| Change of overall severity of clinical symptoms | Clinical Global Impression (CGI) Scale is a clinician-rated scale, comprised of two one-item subscales: Severity of Illness (CGI-S) subscale evaluating the severity of the illness, and Clinical Global Improvement Scale (CGI-I) evaluating change from the initiation of treatment. In both cases, the score is given on a seven-point scale, with higher values indicating higher severity of illness and larger improvement respectively. | Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups | 
| Change of objective cognitive performance (visual attention & task switching) | Trail Making Test for assessing visual attention and task switching. In Trail Making Test, longer reaction time indicates lower level of attention. | Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups | 
| Change of objective cognitive performance (inhibitory ability) | Go/No-go Task for assessing inhibitory ability. In Go/No-go Task, a higher error rate indicates lower inhibition control. | Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups | 
| Change of objective cognitive performance (working memory by digit span) | Digit Span Task for assessing working memory capacity. In Digit Span Task, a higher number of recalled digits indicates better working memory. | Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups | 
| Change of objective cognitive performance (working memory by N-Back) | N-back Task for assessing working memory capacity and manipulation. In N-back Task, a d prime score will be calculated based on the signal detection theory, where a higher score indicates better working memory performance. | Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups | 
| Change of objective cognitive performance (episodic memory) | Chinese Auditory Verbal Learning Task for assessing episodic memory, where a higher number of recalled words indicates better episodic memory performance. | Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups | 
| Change of objective cognitive performance (problem solving) | Wisconsin Card Sorting Test for assessing problem solving. In Wisconsin Card Sorting Test, lower executive functioning is indicated by a higher percentage of persistent errors and a higher number of trials taken to complete the first category. | Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups | 
| Change of sleep related attention bias | Sleep-related Dot-Probe Task for assessing sleep-related attention bias. In the Sleep-related Dot-probe Task, a higher attention bias score indicates higher vigilance towards sleep-related stimuli. | Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups | 
| Change of risk-taking & decision making | Balloon Analogue Risk Task for assessing risk-taking and decision-making. In Balloon Analogue Risk Task, a score will be calculated by averaging the number of pumps on unexploded blue balloons, where a higher score indicates more risk-taking and impulsive propensities. | Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Youth, Insomnia