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Effects of Group-based and Digitally Delivered CBT-I in Youth

Primary Purpose

Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
digital CBTI
group CBTI
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring youth, sleep, insomnia, CBT-I

Eligibility Criteria

12 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (1) Chinese aged 12-20 years old (an age range that was similarly adopted in the previous studies to cover a wider developmental span in adolescence);
  • (2) Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
  • (3) Willing to comply with the study protocol;
  • (4) Meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria of insomnia disorder and with a score on Insomnia Severity Index (ISI) - 9 (suggested cut-off for adolescents)

Exclusion Criteria:

  • (1) 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;
  • (2) Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
  • (3) 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 Structured Interview for Sleep Patterns and Disorders (DISP), a validated structured diagnostic interview to assess major sleep disorders according to the International Classification of Sleep Disorder (ICSD) criteria;
  • (4) Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both western medications (e.g. hypnotics, steroids) and over-the-counter (OTC) medications (e.g. melatonin, Traditional Chinese Medicine, TCM);
  • (5) Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
  • (6) In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by Mini-International Neuropsychiatric Interview (MINI);
  • (7) Currently receiving any structured psychotherapy;
  • (8) With hearing or speech deficit; (9) Night shift worker.

Sites / Locations

  • Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

digital cognitive behavioural therapy for insomnia (CBTI)

group cognitive behavioural therapy for insomnia (CBTI)

waitlist

Arm Description

The digital CBTI group will receive 6-session on their smartphone application

The group CBTI will receive 6-session CBTI in group

The waitlist group will receive treatment sessions after about 10 weeks' time

Outcomes

Primary Outcome Measures

Change of insomnia symptoms
Insomnia symptoms measured by Insomnia Severity Index (ISI). 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 in 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 [Time Frame: Baseline, Post-Treatment (at the conclusion of the last session) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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
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 in Objective Sleep Measures - Time in Bed (TIB)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: time in bed (TIB) in hours
Change in Objective Sleep Measures - 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 in Objective Sleep Measures - 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 in Objective Sleep Measures - Sleep Efficiency (SE)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, %
Change in Self-Report Chronotype Measures
The Munich Chronotype Questionnaire (MCTQ) is a self-report measures of sleeping patterns during weekdays and weekends separately. The Mid-Sleep Time (MSF/MSFsc) are used to as an indicator of chronotype, where individuals with earlier mid-sleep time reflect a morning chronotype and later mid-sleep time reflect an evening chronotype.
Change of Depressive Symptoms (Assessor-rated)
Children's Depression Rating Scale (CDRS-R) is a 17-item rating scale based on a semistructured interview with children. Possible scores range from 17 to 113, with higher scores indicating severer depressive symptoms.
Change of Self-report states of depression and anxiety 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 Self-report emotional states of depression, anxiety and stress
Depression Anxiety Stress Scales (DASS-21) consists of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS scales contains 14 items. Higher scores suggest more depression, anxiety and stress, respectively.
Change of Self-report depressive symptoms
Beck's Depression Inventory (BDI) consists of 13 self-report items designed to measure depressive symptoms. Higher scores suggest high level of depression
Change of clinically depressive symptoms
Patient Health Questionnaire-9 (PHQ-9) consists of 9 self-report items designed to assess clinically significant depression. Higher scores indicate high level of depression.
Change of clinically anxiety symptoms
General Anxiety Disorder-7 (GAD-7) consists of 7 self-report items designed to assess general anxiety symptoms. Higher scores indicate high level of anxiety.
Change of subjective mental well-being
The World Health Organisation- Five Well-Being Index (WHO-5) consists of 5 self-report items designed to measure subjective well-being. Higher scores indicate better well-being.
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 sleep reactivity
Ford Insomnia Response to Stress Test (FIRST) consists of 9 items designed to measure sleep reactivity. Possible scores range from 9 to 36. A higher score indicates higher sleep activity.
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 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)
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 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 psychopathology, 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 decisionmaking. 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.
Change of implicit cognition of suicide or death
Suicide Implicit Association Test (IAT) for assessing implicit cognition of suicide or death. In the Suicide Implicit Association Test, positive D-scores indicate stronger implicit identification with death and negative D scores indicate stronger implicit identification with life
Change of emotion regulation abilities
Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-reported scale measuring emotion regulation problems. Every item uses a 1-to-5 Likert scale, with 1 represents "Almost never" and 5 represents "Almost always". Total score ranges from 36 to 180. Higher score represents higher difficulties in regulating emotions. Sub-scores will also be calculated on the following subscales: i. Nonacceptance of emotional responses ii. Difficulty engaging in goal-directed behavior iii. Impulse control difficulties iv. Lack of emotional awareness v. Limited access to emotion regulation strategies vi. Lack of emotional clarity
Change of emotion regulation tendency/capacity
Emotion regulation questionnaire - frequency/capacity (ERQ-f/ERQ-c) is a 28-item scale designed to measure respondents' tendency/capacity to regulate their emotions in three ways: (1) Cognitive Reappraisal, (2) Expressive Suppression and (3) Distraction. Scores will be calculated separately for each subscale, ranging from 4 to 42. Each item will be answered on a 7-point Likert-type scale ranging from 1(strongly disagree) to 7 (strongly agree). For ERQ-f, higher score represents higher frequency of using certain regulation method. For ERQ-c, higher score represents higher capacity of using certain regulation method.
Change of ability/efficiency in using different emotion regulation strategies
Emotion regulation task is a paradigm used to examined subjects' ability/efficiency in using different emotion regulation strategies (i.e., watch, reappraisal and distraction). Subject will first see a negative or neutral picture, followed by instructions on using which strategy to regulate their emotions induced by the picture (watch, reappraisal or distraction). There are four conditions: neutral-watch, negative-watch, negative-reappraisal, negative-distraction. After each picture, subjective emotional valence and arousal ratings (ranging from 1-9) will be collected. To examine the subjects' different emotion regulation ability, valence and arousal ratings will be analysed by comparing different conditions, groups, and time (pre/post-treatment).
Change of Awareness of Narrative Identity Questionnaire
Awareness of Narrative Identity Questionnaire (ANIQ) consists of 20 self-report items designed to assess Awareness of Narrative Identity, with a rating of 0-10 for each item. Higher scores indicate high level of awareness of narrative Identity.
Change of social support measure
social support measure contains 12-items measuring three factors: tangible support, informational support, and emotional support received from their social environment. Each item is rated on a 4-point scale (1=never, 2=once in a while; 3=fairly often; 4=very often), totalling to a single global composite score, with higher scores indicating greater social support.
Change of narrative coherence
To assess the coherence of the participants' narratives, they will be asked to complete a writing task with the following a narrative coherence prompt. The measure assesses the three dimensions of coherence as defined by Reese et al (2011) : contextual, chronology, and theme. Each of the three subdimensions will be scored on a 4-point scale, which will be summed together into a total coherence score.
Change of verbal fluency
Category Fluency Task will be used to assess verbal fluency. The total number of words produced will be summed and transformed into z-scores in comparison to local norms

Full Information

First Posted
February 14, 2022
Last Updated
September 19, 2023
Sponsor
The University of Hong Kong
Collaborators
Chinese University of Hong Kong, University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT05270369
Brief Title
Effects of Group-based and Digitally Delivered CBT-I in Youth
Official Title
Effects of Group-based and Digitally Delivered Cognitive Behavioural Therapy for Insomnia (CBT-I) in Youth: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (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, University of Oxford

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
Adolescence is a critical transitional stage characterised by a cascade of developmental changes in biological, cognitive, and psychological functioning. Sleep problems, particularly insomnia, are prevalent in adolescents, with a prevalence rate as high as 36%. Insomnia symptoms, presented as the problems initiating sleep or maintaining sleep, have often 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. This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in reducing insomnia severity in youth with insomnia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
youth, sleep, insomnia, CBT-I

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
digital cognitive behavioural therapy for insomnia (CBTI)
Arm Type
Experimental
Arm Description
The digital CBTI group will receive 6-session on their smartphone application
Arm Title
group cognitive behavioural therapy for insomnia (CBTI)
Arm Type
Experimental
Arm Description
The group CBTI will receive 6-session CBTI in group
Arm Title
waitlist
Arm Type
No Intervention
Arm Description
The waitlist group will receive treatment sessions after about 10 weeks' time
Intervention Type
Behavioral
Intervention Name(s)
digital CBTI
Intervention Description
The app-based intervention will consists of 6 weekly sessions and will be delivered within a 10-week window. The treatment components aim to address the behavioural, cognitive and physiological factors perpetuating insomnia whilst considering the sleep and circadian features in adolescents and developmental context with the following key elements: psycho-education about sleep, circadian rhythm and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention
Intervention Type
Behavioral
Intervention Name(s)
group CBTI
Intervention Description
The group-based CBT-I intervention will consist of 6 weekly sessions (90-min, 5-8 adolescents in each group) and will be delivered within a 10-week window. The treatment components aim to address the behavioural, cognitive and physiological factors perpetuating insomnia whilst considering the sleep and circadian features in adolescents and developmental context with the following key elements: psycho-education about sleep, circadian rhythm and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention
Primary Outcome Measure Information:
Title
Change of insomnia symptoms
Description
Insomnia symptoms measured by Insomnia Severity Index (ISI). 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups
Secondary Outcome Measure Information:
Title
Change in 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the 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 (at the conclusion of the last session) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups]
Time Frame
Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups
Title
Change in Objective Sleep Measures - 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups
Title
Change in Objective Sleep Measures - 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change in Objective Sleep Measures - 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change in Objective Sleep Measures - Sleep Efficiency (SE)
Description
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, %
Time Frame
Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change in Self-Report Chronotype Measures
Description
The Munich Chronotype Questionnaire (MCTQ) is a self-report measures of sleeping patterns during weekdays and weekends separately. The Mid-Sleep Time (MSF/MSFsc) are used to as an indicator of chronotype, where individuals with earlier mid-sleep time reflect a morning chronotype and later mid-sleep time reflect an evening chronotype.
Time Frame
Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change of Depressive Symptoms (Assessor-rated)
Description
Children's Depression Rating Scale (CDRS-R) is a 17-item rating scale based on a semistructured interview with children. Possible scores range from 17 to 113, with higher scores indicating severer depressive symptoms.
Time Frame
Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change of Self-report states of depression and anxiety 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change of Self-report emotional states of depression, anxiety and stress
Description
Depression Anxiety Stress Scales (DASS-21) consists of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS scales contains 14 items. Higher scores suggest more depression, anxiety and stress, respectively.
Time Frame
Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change of Self-report depressive symptoms
Description
Beck's Depression Inventory (BDI) consists of 13 self-report items designed to measure depressive symptoms. Higher scores suggest high level of depression
Time Frame
Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change of clinically depressive symptoms
Description
Patient Health Questionnaire-9 (PHQ-9) consists of 9 self-report items designed to assess clinically significant depression. Higher scores indicate high level of depression.
Time Frame
Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change of clinically anxiety symptoms
Description
General Anxiety Disorder-7 (GAD-7) consists of 7 self-report items designed to assess general anxiety symptoms. Higher scores indicate high level of anxiety.
Time Frame
Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change of subjective mental well-being
Description
The World Health Organisation- Five Well-Being Index (WHO-5) consists of 5 self-report items designed to measure subjective well-being. Higher scores indicate better well-being.
Time Frame
Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change of sleep reactivity
Description
Ford Insomnia Response to Stress Test (FIRST) consists of 9 items designed to measure sleep reactivity. Possible scores range from 9 to 36. A higher score indicates higher sleep activity.
Time Frame
Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change of Quality of Life (KIDSCREEN-27)
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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 psychopathology, 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change of risk-taking & decision making
Description
Balloon Analogue Risk Task for assessing risk-taking and decisionmaking. 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 (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change of implicit cognition of suicide or death
Description
Suicide Implicit Association Test (IAT) for assessing implicit cognition of suicide or death. In the Suicide Implicit Association Test, positive D-scores indicate stronger implicit identification with death and negative D scores indicate stronger implicit identification with life
Time Frame
Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Title
Change of emotion regulation abilities
Description
Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-reported scale measuring emotion regulation problems. Every item uses a 1-to-5 Likert scale, with 1 represents "Almost never" and 5 represents "Almost always". Total score ranges from 36 to 180. Higher score represents higher difficulties in regulating emotions. Sub-scores will also be calculated on the following subscales: i. Nonacceptance of emotional responses ii. Difficulty engaging in goal-directed behavior iii. Impulse control difficulties iv. Lack of emotional awareness v. Limited access to emotion regulation strategies vi. Lack of emotional clarity
Time Frame
Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
Title
Change of emotion regulation tendency/capacity
Description
Emotion regulation questionnaire - frequency/capacity (ERQ-f/ERQ-c) is a 28-item scale designed to measure respondents' tendency/capacity to regulate their emotions in three ways: (1) Cognitive Reappraisal, (2) Expressive Suppression and (3) Distraction. Scores will be calculated separately for each subscale, ranging from 4 to 42. Each item will be answered on a 7-point Likert-type scale ranging from 1(strongly disagree) to 7 (strongly agree). For ERQ-f, higher score represents higher frequency of using certain regulation method. For ERQ-c, higher score represents higher capacity of using certain regulation method.
Time Frame
Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
Title
Change of ability/efficiency in using different emotion regulation strategies
Description
Emotion regulation task is a paradigm used to examined subjects' ability/efficiency in using different emotion regulation strategies (i.e., watch, reappraisal and distraction). Subject will first see a negative or neutral picture, followed by instructions on using which strategy to regulate their emotions induced by the picture (watch, reappraisal or distraction). There are four conditions: neutral-watch, negative-watch, negative-reappraisal, negative-distraction. After each picture, subjective emotional valence and arousal ratings (ranging from 1-9) will be collected. To examine the subjects' different emotion regulation ability, valence and arousal ratings will be analysed by comparing different conditions, groups, and time (pre/post-treatment).
Time Frame
Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
Title
Change of Awareness of Narrative Identity Questionnaire
Description
Awareness of Narrative Identity Questionnaire (ANIQ) consists of 20 self-report items designed to assess Awareness of Narrative Identity, with a rating of 0-10 for each item. Higher scores indicate high level of awareness of narrative Identity.
Time Frame
Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
Title
Change of social support measure
Description
social support measure contains 12-items measuring three factors: tangible support, informational support, and emotional support received from their social environment. Each item is rated on a 4-point scale (1=never, 2=once in a while; 3=fairly often; 4=very often), totalling to a single global composite score, with higher scores indicating greater social support.
Time Frame
Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
Title
Change of narrative coherence
Description
To assess the coherence of the participants' narratives, they will be asked to complete a writing task with the following a narrative coherence prompt. The measure assesses the three dimensions of coherence as defined by Reese et al (2011) : contextual, chronology, and theme. Each of the three subdimensions will be scored on a 4-point scale, which will be summed together into a total coherence score.
Time Frame
Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
Title
Change of verbal fluency
Description
Category Fluency Task will be used to assess verbal fluency. The total number of words produced will be summed and transformed into z-scores in comparison to local norms
Time Frame
Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) Chinese aged 12-20 years old (an age range that was similarly adopted in the previous studies to cover a wider developmental span in adolescence); (2) Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18); (3) Willing to comply with the study protocol; (4) Meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria of insomnia disorder and with a score on Insomnia Severity Index (ISI) - 9 (suggested cut-off for adolescents) Exclusion Criteria: (1) 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; (2) Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease); (3) 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 Structured Interview for Sleep Patterns and Disorders (DISP), a validated structured diagnostic interview to assess major sleep disorders according to the International Classification of Sleep Disorder (ICSD) criteria; (4) Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both western medications (e.g. hypnotics, steroids) and over-the-counter (OTC) medications (e.g. melatonin, Traditional Chinese Medicine, TCM); (5) Having been enrolled in any other clinical trial investigational products within one month at the entry of the study; (6) In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by Mini-International Neuropsychiatric Interview (MINI); (7) Currently receiving any structured psychotherapy; (8) With hearing or speech deficit; (9) 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 and 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 X Li

12. IPD Sharing Statement

Learn more about this trial

Effects of Group-based and Digitally Delivered CBT-I in Youth

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