InsomniaNCT06358898
Digital Mood-enhanced CBT-I to Improve Depressive Symptoms in Adolescents
A study testing Standard dCBT-I and Modified Mood enhanced CBT-I (M-dCBT-I) in people with Insomnia and Depression, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Emerging encouraging evidence showed that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Insomnia, Depression, Adolescent
- What is being tested?
- Standard dCBT-I and Modified Mood enhanced CBT-I (M-dCBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Chinese adolescent aged 12-18 years old
- presence of insomnia problems as defined by insomnia severity index ≥ 9 (locally validated cut off for detecting clinical insomnia in adolescents)
- presence of depressive problems as defined by Patient Health Questionnaire-9 (PHQ-9) using cut off of 10 for detecting clinical depression
- ability to read and understand Chinese
- possession of smartphone
Who cannot join
- presence of prominent suicidality (suicide plans and suicide attempts) as determined by the Mini-International Neuropsychiatric Interview (MINI)
- a clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability
- presence of other sleep disorders that significantly affect sleep continuity or sleep quality (e.g. restless leg symptoms or obstructive sleep apnea syndrome) as determined by validated Diagnostic Interview for Sleep Patterns and Disorders
- currently receiving psychological treatment for insomnia and/or pharmacological treatment for depression
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Psychiatry, the Chinese University of Hong Kong
Shatin, New Territories
Rachel Ngan Yin Chan, PhD, 39710548, rachel.chan@cuhk.edu.hk
Jucheng Yu, PhD, 39710548, juchengyu@cuhk.edu.hk
About this study
Official title: Effect of a Smartphone-based, Mood-enhanced Cognitive Behavioral Therapy for Insomnia in Adolescents At Risk of Depression: A Cluster Randomized Trial
Emerging encouraging evidence showed that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population. This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment.
Read the detailed description
Adolescence is a critical transitional stage accompanied by the emergence of mental disorders, with major depressive disorder (MDD) being the most common mental disorder. The point prevalence of depression ranges from 3% to 18% across different studies. In addition, according to our previous studies, approximately 10% of adolescents experience insomnia disorders, and 36% have insomnia symptoms. Adolescent concurrently experiencing sleep and mood problems are typically at a higher risk of adverse health outcomes. This particular group is usually much more difficult to treat, with a poorer prognosis, suggesting that this group maybe in particular need for effective treatment.
There is accumulating evidence that adolescent sleep and mood problems can be treated successfully using cognitive behavioral therapy (CBT), which is one of the most extensively evaluated non-pharmacological approach for managing either depression or insomnia symptoms in adolescents. Cognitive behavioral therapy for depression (CBT-D) involves psychoeducation and addresses cognitive restructuring for unrealistic thinking contribute to depressed mood and behavioral strategies to increase pleasant activities. While cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment in managing adult insomnia, it has gained increasing empirical evidence in managing adolescent insomnia. The high comorbidity of insomnia and depression calls for the need for addressing both problems due to the fact that residual insomnia or residual depressive symptoms could further hasten a relapse to the other comorbid disorder. In addition, depression becomes more difficult to treat in the presence of insomnia. In fact, there has, however, been emerging encouraging evidence showing that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population.
This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment. Primary outcomes include the depressive symptoms as measured by PHQ-9, while secondary outcomes include clinician rated depression scale (HRSD), insomnia (ISI), sleep-related measures (Sleep diary variables, dysfunctional sleep belief), daytime sleepiness, anxiety (HADS), quality of life (Kidscreen-27). Outcome measurement will be conducted at baseline, postintervention, 6-month and 12-month follow up.
- Conditions
- Insomnia, Depression, Adolescent
- Being tested
- Standard dCBT-I, Modified Mood enhanced CBT-I (M-dCBT-I)
- Keywords
- Insomnia, Depression, Adolescent
- 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.
Standard dCBT-IBehavioural
This standard digital CBT-I intervention will cover (1) psycho-education about sleep, circadian and sleep hygiene education, (2) stimulus control, (3) sleep restriction, (4) relaxation techniques, (5) structured worry time, (6) cognitive restructuring (targeting sleep-related dysfunctional cognitions), and (7) relapse prevention. In order to have comparable dosage as modified CBT-I, the treatment will be dispersed to 8 modules (8-week) which is still in the range of standard CBT-I duration (usually last for 6-8weeks).
Modified Mood enhanced CBT-I (M-dCBT-I)Behavioural
Additional depression specific components will be added to the standard CBT-I, including behavioral activation and problem solving.
| Study group | Role | What they receive |
|---|---|---|
| Standard dCBT-I | Active comparator | Treatment content for insomnia was structured and based on the well-established CBT elements for treating insomnia, with developmental adaptation and age-appropriate modification specific for adolescent population. For example, regularity of sleep wake pattern and circadian component will be further emphasized in this age group given the high prevalence of social jetlag resulting from the early school schedule and their natural development delay in circadian rhythm. Receives: Behavioral: Standard dCBT-I |
| Modified Mood enhanced CBT-I (M-dCBT-I) | Experimental | For mood-enhanced dCBT-I (M-dCBT-I), apart from including core CBT-I component, additional depression specific component including behavioral activation and problem solving. More specifically, cognitive restructuring techniques will cover both unhelpful belief relevant to both insomnia and depression. Psychoeducation will also cover both condition and vignette example will be included in the treatment. Receives: Behavioral: Modified Mood enhanced CBT-I (M-dCBT-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
The severity of depressive symptoms as measured by Patient Health Questionnaire 9-item (PHQ-9): locally validated in adolescents and commonly used self-administered questionnaire to assess depressive symptoms and severity. Scores range from 0 to 27, with higher score indicate higher level of depression.
Measured: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Secondary outcomes (8)
Assessor-rated depressive symptomatology
Hamilton Rating Scale for Depression (HRSD), a 17-item clinician-administered instrument, will be used to assess depressive symptomatology. Scores range from 0 to 52, with higher score indicate higher level of depression.
Measured: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Overall severity of depression symptoms
Improvement of depression, in reference to the severity prior to the start of the treatment, will be rated using the Clinical Global Improvement Scale (CGI-I), on a scale of 1 (very much improved) to 7 (very much worse).
Measured: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Severity of insomnia symptoms
Severity of insomnia symptoms will be measured by Insomnia Severity Index (ISI). ISI is a self-report measure designed to assess the nature, severity and impact of insomnia, with a higher total score suggesting more severe insomnia symptoms. Scores range from 0 to 28.
Measured: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Sleep-wake pattern
Prospective 7-day Sleep diary will be used to record sleep-wake pattern including sleep duration, wakeup time, bedtime and sleep latency.
Measured: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Sleep-related beliefs and cognitions
Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) will be used to measure faulty sleep-related beliefs and cognitions, which are cognitive aspects typically involved in the maintenance of insomnia. The total score is calculated from the average score of all the items on the scale and could range from 0 to 10.
Measured: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Daytime sleepiness
8-item Pediatric Daytime Sleepiness Scale (PDSS) will be used to assess adolescents' daytime sleepiness in school children and adolescents. It is an 8-item inventory designed for use with school children and youths, with a higher score indicating greater sleepiness. Scores ranged from 0 to 32.
Measured: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Anxiety and depression symptoms
Cantonese-Chinese version Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety and depression. It has been validated in the community-based sample of adolescents in Hong Kong.
A higher total score of each subscale represents a greater severity of depression/anxiety. The total score for each subscale ranges from 0 to 21.
Measured: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Quality of life by KIDSCREEN-27
KIDSCREEN-27 health questionnaire for children and young people will be used to measure quality of life.
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, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start20 Apr 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Chinese 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 343 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN NGAN YIN, Chinese University of Hong Kong
- Investigators
- Rachel Ngan Yin Chan, PhD, Principal investigator, Department of Psychiatry, the Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358898
- Sponsor's protocol ID
- 20221207
- Status last verified
- Jul 2025
- First submitted
- 2 Apr 2024
- Last updated
- 10 Jul 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 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Smartphone-based, Mood-enhanced Cognitive Behavioral Therapy for Insomnia in Adolescents At Risk of Depression: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06358898
- Acronym / sponsor ID
- 20221207
- Conditions
- Insomnia, Depression, Adolescent
- Keywords
- Insomnia, Depression, Adolescent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 343 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Apr 2024 (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.
Emerging encouraging evidence showed that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population. This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment.
Detailed description
Adolescence is a critical transitional stage accompanied by the emergence of mental disorders, with major depressive disorder (MDD) being the most common mental disorder. The point prevalence of depression ranges from 3% to 18% across different studies. In addition, according to our previous studies, approximately 10% of adolescents experience insomnia disorders, and 36% have insomnia symptoms. Adolescent concurrently experiencing sleep and mood problems are typically at a higher risk of adverse health outcomes. This particular group is usually much more difficult to treat, with a poorer prognosis, suggesting that this group maybe in particular need for effective treatment.
There is accumulating evidence that adolescent sleep and mood problems can be treated successfully using cognitive behavioral therapy (CBT), which is one of the most extensively evaluated non-pharmacological approach for managing either depression or insomnia symptoms in adolescents. Cognitive behavioral therapy for depression (CBT-D) involves psychoeducation and addresses cognitive restructuring for unrealistic thinking contribute to depressed mood and behavioral strategies to increase pleasant activities. While cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment in managing adult insomnia, it has gained increasing empirical evidence in managing adolescent insomnia. The high comorbidity of insomnia and depression calls for the need for addressing both problems due to the fact that residual insomnia or residual depressive symptoms could further hasten a relapse to the other comorbid disorder. In addition, depression becomes more difficult to treat in the presence of insomnia. In fact, there has, however, been emerging encouraging evidence showing that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population.
This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment. Primary outcomes include the depressive symptoms as measured by PHQ-9, while secondary outcomes include clinician rated depression scale (HRSD), insomnia (ISI), sleep-related measures (Sleep diary variables, dysfunctional sleep belief), daytime sleepiness, anxiety (HADS), quality of life (Kidscreen-27). Outcome measurement will be conducted at baseline, postintervention, 6-month and 12-month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dCBT-I | Active comparator | Behavioral: Standard dCBT-ITreatment content for insomnia was structured and based on the well-established CBT elements for treating insomnia, with developmental adaptation and age-appropriate modification specific for adolescent population. For example, regularity of sleep wake pattern and circadian component will be further emphasized in this age group given the high prevalence of social jetlag resulting from the early school schedule and their natural development delay in circadian rhythm. |
| Modified Mood enhanced CBT-I (M-dCBT-I) | Experimental | Behavioral: Modified Mood enhanced CBT-I (M-dCBT-I)For mood-enhanced dCBT-I (M-dCBT-I), apart from including core CBT-I component, additional depression specific component including behavioral activation and problem solving. More specifically, cognitive restructuring techniques will cover both unhelpful belief relevant to both insomnia and depression. Psychoeducation will also cover both condition and vignette example will be included in the treatment. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Chinese adolescent aged 12-18 years old
- presence of insomnia problems as defined by insomnia severity index ≥ 9 (locally validated cut off for detecting clinical insomnia in adolescents)
- presence of depressive problems as defined by Patient Health Questionnaire-9 (PHQ-9) using cut off of 10 for detecting clinical depression
- ability to read and understand Chinese
- possession of smartphone
Key exclusion criteria (4 listed)
- presence of prominent suicidality (suicide plans and suicide attempts) as determined by the Mini-International Neuropsychiatric Interview (MINI)
- a clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability
- presence of other sleep disorders that significantly affect sleep continuity or sleep quality (e.g. restless leg symptoms or obstructive sleep apnea syndrome) as determined by validated Diagnostic Interview for Sleep Patterns and Disorders
- currently receiving psychological treatment for insomnia and/or pharmacological treatment for depression
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 |
|---|---|---|
| Standard dCBT-IThis standard digital CBT-I intervention will cover (1) psycho-education about sleep, circadian and sleep hygiene education, (2) stimulus control, (3) sleep restriction, (4) relaxation techniques, (5) structured worry time, (6) cognitive restructuring (targeting sleep-related dysfunctional cognitions), and (7) relapse prevention. In order to have comparable dosage as modified CBT-I, the treatment will be dispersed to 8 modules (8-week) which is still in the range of standard CBT-I duration (usually last for 6-8weeks). | Behavioural | Standard dCBT-I |
| Modified Mood enhanced CBT-I (M-dCBT-I)Additional depression specific components will be added to the standard CBT-I, including behavioral activation and problem solving. | Behavioural | Modified Mood enhanced CBT-I (M-dCBT-I) |
Primary outcome
Depressive symptoms
Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
The severity of depressive symptoms as measured by Patient Health Questionnaire 9-item (PHQ-9): locally validated in adolescents and commonly used self-administered questionnaire to assess depressive symptoms and severity. Scores range from 0 to 27, with higher score indicate higher level of depression.
8 secondary outcomes
Assessor-rated depressive symptomatology
Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Overall severity of depression symptoms
Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Severity of insomnia symptoms
Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Sleep-wake pattern
Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Sleep-related beliefs and cognitions
Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Daytime sleepiness
Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Anxiety and depression symptoms
Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Quality of life by KIDSCREEN-27
Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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.
Rachel Ngan Yin Chan, PhD principal investigator
Department of Psychiatry, the Chinese 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 Standard dCBT-I and Modified Mood enhanced CBT-I (M-dCBT-I) in people with Insomnia and Depression, run by Chinese 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Ngan Yin Chan, PhD (39710548, rachel.chan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up). 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 10 Jul 2025.