Back to resultsEffects of Self-help Versus Group Cognitive Behavioural Therapy for Insomnia in Youth
Primary Purpose
Insomnia
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
CBTI
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Adolescents, Youth, Insomnia
Eligibility Criteria
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.
Sites / Locations
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Group CBTI
Email-delivered CBTI
Waiting-list control
Arm Description
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.
The email delivered self-guided CBT-I consists of 8 weekly learning sessions. Participants will receive an email embedded with session materials each week.
Participants will not receive any active treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
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
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
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, %
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
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
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
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
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.
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.
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.
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.
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
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.
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.
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.
Change of depressive symptoms (assessor-rated)
Hamilton Depression Rating Scale (HAM-D): 17 item for assessing depression
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03522701
First Posted
May 1, 2018
Last Updated
May 23, 2022
Sponsor
The University of Hong Kong
Collaborators
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03522701
Brief Title
Effects of Self-help Versus Group Cognitive Behavioural Therapy for Insomnia in Youth
Official Title
Effects of Self-help Versus Group Cognitive Behavioural Therapy for Insomnia in Youth: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Adolescents, Youth, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomised, assessor-blind, parallel group controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group CBTI
Arm Type
Experimental
Arm Description
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.
Arm Title
Email-delivered CBTI
Arm Type
Active Comparator
Arm Description
The email delivered self-guided CBT-I consists of 8 weekly learning sessions. Participants will receive an email embedded with session materials each week.
Arm Title
Waiting-list control
Arm Type
No Intervention
Arm Description
Participants will not receive any active treatment.
Intervention Type
Behavioral
Intervention Name(s)
CBTI
Intervention Description
Refer to the arm description
Primary Outcome Measure Information:
Title
Change of insomnia symptoms
Description
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.
Time Frame
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 Measure Information:
Title
Change of sleep quality
Description
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.
Time Frame
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
Title
Change of sleep diary measure (time in bed, TIB)
Description
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: time in bed (TIB) in hours
Time Frame
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]
Title
Change of sleep diary measure (total sleep time, TST)
Description
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours
Time Frame
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
Title
Change of sleep diary measure (sleep onset latency, SOL)
Description
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (SOL) in mins
Time Frame
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]
Title
Change of sleep diary measure (wake after sleep onset, WASO)
Description
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (WASO) in mins
Time Frame
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
Title
Change of sleep diary measure (sleep efficiency, SE)
Description
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, %
Time Frame
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
Title
Change of objective sleep measure (time in bed, TIB)
Description
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: time in bed (TIB) in hours
Time Frame
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
Title
Change of objective sleep measure (total sleep time, TST)
Description
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: total sleep time (TST) in hours
Time Frame
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
Title
Change of objective sleep measure (sleep onset latency, SOL)
Description
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep onset latency (SOL) in mins
Time Frame
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
Title
Change of objective sleep measure (wake after sleep onset, WASO)
Description
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: wake after sleep onset (WASO) in mins
Time Frame
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
Title
Change of daytime sleepiness
Description
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.
Time Frame
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
Title
Change of daytime fatigue
Description
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.
Time Frame
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
Title
Change of quality of life
Description
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.
Time Frame
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
Title
Change of suicidal ideation
Description
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.
Time Frame
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
Title
Change of self-report mood symptoms
Description
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
Time Frame
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
Title
Change of dysfunctional beliefs and attitudes about sleep
Description
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.
Time Frame
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
Title
Change of sleep hygiene and practice
Description
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.
Time Frame
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
Title
Change of pre-sleep arousal
Description
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.
Time Frame
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]
Title
Change of depressive symptoms (assessor-rated)
Description
Hamilton Depression Rating Scale (HAM-D): 17 item for assessing depression
Time Frame
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
Title
Change of overall severity of clinical symptoms
Description
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.
Time Frame
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
Title
Change of objective cognitive performance (visual attention & task switching)
Description
Trail Making Test for assessing visual attention and task switching. In Trail Making Test, longer reaction time indicates lower level of attention.
Time Frame
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
Title
Change of objective cognitive performance (inhibitory ability)
Description
Go/No-go Task for assessing inhibitory ability. In Go/No-go Task, a higher error rate indicates lower inhibition control.
Time Frame
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
Title
Change of objective cognitive performance (working memory by digit span)
Description
Digit Span Task for assessing working memory capacity. In Digit Span Task, a higher number of recalled digits indicates better working memory.
Time Frame
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
Title
Change of objective cognitive performance (working memory by N-Back)
Description
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.
Time Frame
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
Title
Change of objective cognitive performance (episodic memory)
Description
Chinese Auditory Verbal Learning Task for assessing episodic memory, where a higher number of recalled words indicates better episodic memory performance.
Time Frame
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
Title
Change of objective cognitive performance (problem solving)
Description
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.
Time Frame
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
Title
Change of sleep related attention bias
Description
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.
Time Frame
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
Title
Change of risk-taking & decision making
Description
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.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shirley Xin Li, PhD, DClinPsy
Phone
(852)39177035
Email
shirley.li@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley Xin Li, PhD, DClinPsy
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirley Xin Li, PhD,DClinPsy
Phone
852-39177035
Email
shirley.li@hku.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Self-help Versus Group Cognitive Behavioural Therapy for Insomnia in Youth
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