InsomniaNCT03438331
Effects of Group Cognitive Behavioural Therapy on Comorbid Insomnia and Depression in Youth
A study testing Cognitive Behavioural Therapy for Insomnia (CBT-I) and Cognitive Behavioural Therapy for Depression (CBT-D) in people with Insomnia and Depression, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Major depressive disorder (MDD) is among the most common psychiatric disorders among adolescents, and is associated with considerable psychosocial and functional impairments and an elevated risk of suicidal behaviour and completed suicide. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Insomnia, Depression
- What is being tested?
- Cognitive Behavioural Therapy for Insomnia (CBT-I) and Cognitive Behavioural Therapy for Depression (CBT-D)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 May 2018to 26 Mar 2021
- 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 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Chinese aged 12-24 years old;
- Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
- Being able to comply with the study protocol;
- Having a DSM-V diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) >=9; AND a DSM-V diagnosis of depressive disorder
Who cannot join
- A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities;
- Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
- Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, as ascertained by DISP;
- Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);
- In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
- Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
Show all 10Show fewer
- Initiation of or change in antidepressant medication within past 2 months;
- Having been or is currently receiving any structured psychotherapy;
- With hearing or speech deficit;
- Night shift worker.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong
About this study
Official title: Effects of Group Cognitive Behavioural Therapy on Comorbid Insomnia and Depression in Youth: a Randomised, Assessor Blind, Parallel Group Trial
Major depressive disorder (MDD) is among the most common psychiatric disorders among adolescents, and is associated with considerable psychosocial and functional impairments and an elevated risk of suicidal behaviour and completed suicide. Meanwhile, sleep disturbance, particularly insomnia, is among the most prevalent and prominent presenting complaints in adolescents with depression. Despite its high prevalence, insomnia often remains overlooked and under-treated in clinical practice. However, growing evidence suggests an intricate relationship between insomnia and depression, which has become an area in need of further focused attention. This project will involve a randomised controlled trial proposed to examine whether insomnia treatment confers additional benefit to depression treatment in adolescents with comorbid depression and insomnia, for improving sleep and depressive symptoms, and other clinical and daytime symptoms as well as overall functional improvement in both the short and long term. Eligible adolescent participants will be randomised to either intervention (8-week group Cognitive Behavioural Therapy for Insomnia, CBT-I, or 8-week group Cognitive Behavioural Therapy for Depression, CBT-D) or waiting-list control condition. Assessments will be conducted at pre-treatment (week 0), during the treatment (week 2, 4, 6) and post-treatment (week 8/at the conclusion of the last group session). The two active treatment groups will be additionally followed up at posttreatment one-month and six-month.
- Conditions
- Insomnia, Depression
- Being tested
- Cognitive Behavioural Therapy for Insomnia (CBT-I), Cognitive Behavioural Therapy for Depression (CBT-D)
- Keywords
- Insomnia, Depression, Adolescents, Youth
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy for Insomnia (CBT-I)Behavioural
The intervention will consist of 8 weekly group sessions (90-min, 5-8 adolescents in each group) of CBT-I delivered within a 10-week window. The treatment components in the CBT-I aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia and include: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention.
Cognitive Behavioural Therapy for Depression (CBT-D)Behavioural
The intervention will consist of 8 weekly group sessions (90-min, 5-8 adolescents in each group) of CBT-D delivered within a 10-week window. The main treatment elements of CBT-D include: psycho-education about depression, self-monitoring, behavioural activation, improving social skills, communication skills and problem solving skills, cognitive restructuring (addressing negative and irrational thoughts often associated with depression in adolescents), relaxation techniques, and relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | Not described Receives: Behavioral: Cognitive Behavioural Therapy for Insomnia (CBT-I) |
| CBT-D | Active comparator | Not described Receives: Behavioral: Cognitive Behavioural Therapy for Depression (CBT-D) |
| Waiting-list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of self-report mood symptoms
Hospital Anxiety and Depression Scale (HADS) is a self-assessed scale for detecting states of depression and anxiety. The depression subscale range in scores from 0 to 21, with higher scores indicating severer states of depression. Similarly, the anxiety subscale range in scores from 0-21 with higher scores indicating severer states of anxiety. No additional computation will be made with the two subscores.
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of insomnia symptoms
Insomnia Severity Index (ISI) is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Secondary outcomes (28)
Change of sleep quality
Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale consisting of 19 questions. All items are combined to form seven component scores on different aspects of sleep quality, each of which ranges from 0 to 3 points with higher scores representing more sleep disturbance. The seven component scores are added to one global score, which ranges from 0 to 21, with higher scores indicating more difficulties with sleep.
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of objective sleep measure (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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective sleep measure (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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective sleep measure (wake after sleep onset, WASO)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: wake after sleep onset (WASO) in mins
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective sleep measure (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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of quality of life
KIDSCREEN-27 is a 27-item self-rated scale measuring health related quality of life measure for children and adolescents. There are five subscales on: physical well-being (possibly scored from 5 to 25), psychological well-being (possibly scored 7 to 35), autonomy \& parents (possibly scored 7 to 35), peers \& social support (possibly scored 4 to 20), and school environment (possibly scored 4 to 20). A grand total score can be calculated by summing up the five sub scores. In all cases, a higher score represents higher perceived well-being.
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of subjective cognitive performance
Cognitive Failures Questionnaire (CFQ) is a 20-item self-rated scale measuring perceived failures in daily cognitive tasks. Possible total scores range from 0 to 80, with higher scores indicating higher cognitive failures.
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective cognitive performance (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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective cognitive performance (inhibitory ability)
Go/No-go Task for assessing inhibitory ability. In Go/No-go Task, a higher error rate indicates lower inhibition control.
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective cognitive performance (working memory by digit span)
Digit Span Task for assessing working memory capacity. In Digit Span Task, a higher number of recalled digits indicates better working memory.
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective cognitive performance (working memory by N-Back)
N-back Task for assessing working memory capacity and manipulation. In N-back Task, a d prime score will be calculated based on the signal detection theory, where a higher score indicates better working memory performance.
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective cognitive performance (episodic memory)
Chinese Auditory Verbal Learning Task for assessing episodic memory, where a higher number of recalled words indicates better episodic memory performance.
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective cognitive performance (problem solving)
Wisconsin Card Sorting Test for assessing problem solving. In Wisconsin Card Sorting Test, lower executive functioning is indicated by a higher percentage of persistent errors and a higher number of trials taken to complete the first category.
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of sleep related attention bias
Sleep-related Dot-Probe Task for assessing sleep-related attention bias. In the Sleep-related Dot-probe Task, a higher attention bias score indicates higher vigilance towards sleep-related stimuli.
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of risk-taking & decision making
Balloon Analogue Risk Task for assessing risk-taking and decision-making. In Balloon Analogue Risk Task, a score will be calculated by averaging the number of pumps on unexploded blue balloons, where a higher score indicates more risk-taking and impulsive propensities.
Measured: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of overall severity of clinical symptoms
Clinical Global Impression (CGI) Scale is a clinician-rated scale, comprised of two one-item subscales: Severity of Illness (CGI-S) subscale evaluating the severity of 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 (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start15 May 2018
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 133 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
- NCT03438331
- Sponsor's protocol ID
- 27613017
- Status last verified
- May 2022
- First submitted
- 2 Jan 2018
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Group Cognitive Behavioural Therapy on Comorbid Insomnia and Depression in Youth: a Randomised, Assessor Blind, Parallel Group Trial
- ClinicalTrials.gov ID
- NCT03438331
- Acronym / sponsor ID
- 27613017
- Conditions
- Insomnia, Depression
- Keywords
- Insomnia, Depression, Adolescents, Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, University of Oxford
- Study start
- 15 May 2018 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 19 Feb 2018 (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.
Major depressive disorder (MDD) is among the most common psychiatric disorders among adolescents, and is associated with considerable psychosocial and functional impairments and an elevated risk of suicidal behaviour and completed suicide. Meanwhile, sleep disturbance, particularly insomnia, is among the most prevalent and prominent presenting complaints in adolescents with depression. Despite its high prevalence, insomnia often remains overlooked and under-treated in clinical practice. However, growing evidence suggests an intricate relationship between insomnia and depression, which has become an area in need of further focused attention. This project will involve a randomised controlled trial proposed to examine whether insomnia treatment confers additional benefit to depression treatment in adolescents with comorbid depression and insomnia, for improving sleep and depressive symptoms, and other clinical and daytime symptoms as well as overall functional improvement in both the short and long term. Eligible adolescent participants will be randomised to either intervention (8-week group Cognitive Behavioural Therapy for Insomnia, CBT-I, or 8-week group Cognitive Behavioural Therapy for Depression, CBT-D) or waiting-list control condition. Assessments will be conducted at pre-treatment (week 0), during the treatment (week 2, 4, 6) and post-treatment (week 8/at the conclusion of the last group session). The two active treatment groups will be additionally followed up at posttreatment one-month and six-month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Behavioral: Cognitive Behavioural Therapy for Insomnia (CBT-I) |
| CBT-D | Active comparator | Behavioral: Cognitive Behavioural Therapy for Depression (CBT-D) |
| Waiting-list control | No intervention | – |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Chinese aged 12-24 years old;
- Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
- Being able to comply with the study protocol;
- Having a DSM-V diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) >=9; AND a DSM-V diagnosis of depressive disorder
Key exclusion criteria (10 listed)
- A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities;
- Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
- Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, as ascertained by DISP;
- Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);
- In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
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 |
|---|---|---|
| Cognitive Behavioural Therapy for Insomnia (CBT-I)The intervention will consist of 8 weekly group sessions (90-min, 5-8 adolescents in each group) of CBT-I delivered within a 10-week window. The treatment components in the CBT-I aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia and include: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention. | Behavioural | CBT-I |
| Cognitive Behavioural Therapy for Depression (CBT-D)The intervention will consist of 8 weekly group sessions (90-min, 5-8 adolescents in each group) of CBT-D delivered within a 10-week window. The main treatment elements of CBT-D include: psycho-education about depression, self-monitoring, behavioural activation, improving social skills, communication skills and problem solving skills, cognitive restructuring (addressing negative and irrational thoughts often associated with depression in adolescents), relaxation techniques, and relapse prevention. | Behavioural | CBT-D |
Primary outcome
Change of depressive symptoms (assessor-rated)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
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 mood symptoms
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
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 insomnia symptoms
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Insomnia Severity Index (ISI) is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
28 secondary outcomes
Change of sleep quality
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of sleep diary measure (time in bed, TIB)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of sleep diary measure (total sleep time, TST)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of sleep diary measure (sleep onset latency, SOL)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of sleep diary measure (wake after sleep onset, WASO)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of sleep diary measure (sleep efficiency, SE)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of objective sleep measure (time in bed, TIB)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective sleep measure (total sleep time, TST)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective sleep measure (sleep onset latency, SOL)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective sleep measure (wake after sleep onset, WASO)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective sleep measure (sleep efficiency, SE)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of daytime sleepiness
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of daytime fatigue
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of quality of life
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of suicidal ideation
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of subjective cognitive performance
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective cognitive performance (visual attention & task switching)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective cognitive performance (inhibitory ability)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective cognitive performance (working memory by digit span)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective cognitive performance (working memory by N-Back)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective cognitive performance (episodic memory)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of objective cognitive performance (problem solving)
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of sleep related attention bias
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of risk-taking & decision making
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Change of dysfunctional beliefs and attitudes about sleep
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of sleep hygiene and practice
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of pre-sleep arousal
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Change of overall severity of clinical symptoms
Time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
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 24 May 2022.
- Individual participant dataSharing planned: No
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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 Cognitive Behavioural Therapy for Insomnia (CBT-I) and Cognitive Behavioural Therapy for Depression (CBT-D) in people with Insomnia and Depression, 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 10 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 24 May 2022. 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 depressive symptoms (assessor-rated) (time frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups). The study lists 3 primary outcomes in all. 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 24 May 2022.