InsomniaNCT05270369
Effects of Group-based and Digitally Delivered CBT-I in Youth
A study testing digital CBTI and group CBTI in people with Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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%. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Insomnia
- What is being tested?
- digital CBTI and group CBTI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- (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)
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong
About this study
Official title: Effects of Group-based and Digitally Delivered Cognitive Behavioural Therapy for Insomnia (CBT-I) in Youth: a Randomised Controlled Trial
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.
- Conditions
- Insomnia
- Being tested
- digital CBTI, group CBTI
- Keywords
- youth, sleep, insomnia, CBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital CBTIBehavioural
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
group CBTIBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| digital cognitive behavioural therapy for insomnia (CBTI) | Experimental | The digital CBTI group will receive 6-session on their smartphone application Receives: Behavioral: digital CBTI |
| group cognitive behavioural therapy for insomnia (CBTI) | Experimental | The group CBTI will receive 6-session CBTI in group Receives: Behavioral: group CBTI |
| waitlist | No intervention | The waitlist group will receive treatment sessions after about 10 weeks' time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of insomnia symptoms
Insomnia symptoms measured by Insomnia Severity Index (ISI). ISI is a 7-item self-rated scale. Possible scores range from 0 to 28, with higher scores indicating higher insomnia severity.
Measured: 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 outcomes (38)
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.
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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, %
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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, %
Measured: 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
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.
Measured: 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
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.
Measured: 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
Change of Self-report emotional states of depression, anxiety and stress
Depression Anxiety Stress Scales 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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
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:
- 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
Measured: Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
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.
Measured: Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
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).
Measured: Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
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
Measured: Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Jan 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, University of Oxford
- Responsible party
- Principal investigator, Dr. Shirley Xin Li, The University of Hong Kong
- Investigators
- Shirley Xin Li, PhD,DClinPsy, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270369
- Sponsor's protocol ID
- EA200037
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Group-based and Digitally Delivered Cognitive Behavioural Therapy for Insomnia (CBT-I) in Youth: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05270369
- Acronym / sponsor ID
- EA200037
- Conditions
- Insomnia
- Keywords
- youth, sleep, insomnia, CBT-I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, University of Oxford
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| digital cognitive behavioural therapy for insomnia (CBTI) | Experimental | Behavioral: digital CBTIThe digital CBTI group will receive 6-session on their smartphone application |
| group cognitive behavioural therapy for insomnia (CBTI) | Experimental | Behavioral: group CBTIThe group CBTI will receive 6-session CBTI in group |
| waitlist | No intervention | –The waitlist group will receive treatment sessions after about 10 weeks' time |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- (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)
Key exclusion criteria (8 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital CBTIThe 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 | Behavioural | digital cognitive behavioural therapy for insomnia (CBTI) |
| group CBTIThe 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 | Behavioural | group cognitive behavioural therapy for insomnia (CBTI) |
Primary outcome
Change of insomnia 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 6-month and Post-Treatment 12-month for participants in the treatment groups
Insomnia symptoms measured by Insomnia Severity Index (ISI). ISI is a 7-item self-rated scale. Possible scores range from 0 to 28, with higher scores indicating higher insomnia severity.
38 secondary outcomes
Change in Sleep Quality
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
Change of Sleep Diary Measure - Time in Bed (TIB)
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
Change of Sleep Diary Measure - Total Sleep Time (TST)
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
Change of Sleep Diary Measure - Sleep Onset Latency (SOL)
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
Change of Sleep Diary Measure - Wake After Sleep Onset (WASO)
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
Change of Sleep Diary Measure - Sleep Efficiency (SE)
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
Change in Objective Sleep Measures - Time in Bed (TIB)
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
Change in Objective Sleep Measures - Total Sleep Time (TST)
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
Change of objective sleep measure (sleep onset latency, SOL)
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
Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)
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
Change in Objective Sleep Measures - Sleep Efficiency (SE)
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
Change of Depressive Symptoms (Assessor-rated)
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
Change of Self-report states of depression and anxiety 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 6-month and Post-Treatment 12-month for participants in the treatment groups
Change of Self-report emotional states of depression, anxiety and stress
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
Change of Self-report 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 6-month and Post-Treatment 12-month for participants in the treatment groups
Change of subjective mental 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 6-month and Post-Treatment 12-month for participants in the treatment groups
Change of 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 6-month and Post-Treatment 12-month for participants in the treatment groups
Change of sleep hygiene and practice
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
Change of 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 6-month and Post-Treatment 12-month for participants in the treatment groups
Change of sleep reactivity
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
Change of 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 6-month and Post-Treatment 12-month for participants in the treatment groups
Change of Daytime 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 6-month and Post-Treatment 12-month for participants in the treatment groups
Change of Daytime Fatigue
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
Change of Quality of Life (KIDSCREEN-27)
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
Change of Overall Severity of Clinical 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 6-month and Post-Treatment 12-month for participants in the treatment groups
Change of Objective Cognitive Performance (visual attention & task switching)
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
Change of Objective Cognitive Performance (inhibitory ability)
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
Change of Objective Cognitive Performance (working memory by digit span)
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
Change of Objective Cognitive Performance (working memory by N-Back)
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
Change of Objective Cognitive Performance (episodic 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 6-month and Post-Treatment 12-month for participants in the treatment groups
Change of Objective Cognitive Performance (problem solving)
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
Change of sleep related attention bias
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
Change of risk-taking & decision making
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
Change of implicit cognition of suicide or death
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
Change of emotion regulation abilities
Time frame: Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
Change of emotion regulation tendency/capacity
Time frame: Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
Change of ability/efficiency in using different emotion regulation strategies
Time frame: Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
Change of verbal fluency
Time frame: Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley Xin Li, PhD,DClinPsy principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital CBTI and group CBTI in people with Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of insomnia 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 6-month and Post-Treatment 12-month for participants in the treatment groups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.