InsomniaNCT06156306
CBT-I Versus CBT-I+ACT for Youths With Insomnia and Anxiety
A study testing CBT-I and CBT-I combined ACT in people with Insomnia and Anxiety, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Insomnia in adolescents and youth is a long-standing public health concern due to its high prevalence and association with various physical and mental health problems. Insomnia and psychiatric disorders are highly comorbid and intercorrelated in adolescents. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- What is being tested?
- CBT-I and CBT-I combined ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Dec 2023to 31 Dec 2025
- 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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth who meet the following criteria would be eligible for taking part in this trial:
- Chinese youth aged 15-24 years old, ii. Presence of insomnia problems as defined by insomnia severity index (ISI) using cut-off of 9, which has been locally validated cut off for detecting clinical insomnia), iii. Presence of anxiety features as defined by General Anxiety Disorder-7 (GAD-7) using cut-off of 10 for detecting clinical anxiety, iv. Ability to listen, speak, and read Chinese and Cantonese, and v. Written informed consent of participation into the study is given by youth and his/her parent's if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old vi. Possession of smartphone
Who cannot join
- A youth would be excluded from the study if meeting one or more of the following criteria:
- A clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability ii. Having a diagnosed sleep disorder (e.g. delayed sleep phase and narcolepsy) that may potentially contribute to the disruption of sleep quantity and quality as determined by validated Diagnostic Interview for Sleep Patterns and Disorders (DISP) iii. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by The Structured Clinical Interview (SCID) iv. Currently receiving psychological treatment and/or pharmacological treatment for insomnia or anxiety disorder.
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
About this study
Official title: Effectiveness of CBT-I and CBT-I Combined ACT for Insomnia and Anxiety Symptoms in Youth: A Randomised Control Trial
Insomnia in adolescents and youth is a long-standing public health concern due to its high prevalence and association with various physical and mental health problems. Insomnia and psychiatric disorders are highly comorbid and intercorrelated in adolescents. Among all mental disorders, anxiety has been shown to be have high comorbidity with insomnia, affecting approximately 30% of individuals. CBT for insomnia (CBT-I) has been shown to be effective in improving sleep complaints and short-term improvement in mood while previous systematic reviews of interventional studies have demonstrated the effectiveness of acceptance and commitment therapy (ACT) interventions in treating insomnia, both as a primary condition and with other physical and/or mental health comorbidities. This study aims to compare the effect of CBT-I and CBT-I combined ACT in improving anxiety symptoms in youth.
Read the detailed description
Insomnia and psychiatric disorders are highly comorbid and intercorrelated in adolescents. Among all mental disorders, anxiety has been shown to be have high comorbidity with insomnia, affecting approximately 30% of individuals. Moreover, approximately three-quarters of anxious youth also report sleep-related problems. Literature reviews have investigated the relationship and the shared underlying mechanisms between sleep and anxiety. Anxiety sensitivity and pre-sleep arousal have been found to play a critical role in difficulty initiating sleep, which is the most common insomnia symptoms in adolescent population, partially due their natural delay of circadian rhythm. The findings suggest shared neurological and cognitive features that may account for dysregulation of both sleep and affect. Management targeting both sleep and anxiety is recommended due to potentially higher treatment efficacy and cost-effectiveness.
Accumulating evidence supports the effectiveness of cognitive-behavioural therapy for insomnia (CBT-I) and acceptance and commitment therapy (ACT) for addressing sleep and mood problems in adolescents. However, Only a few studies have directly compared the effectiveness of CBT-I and ACT. Past studies have shown that both CBT-I and ACT were effective in treating insomnia in adults.
This current study aims to compare the effect of CBT-I and CBT-I combined ACT in improving anxiety symptoms in youth. The primary hypothesis is that subjects in CBT-I combined ACT will have fewer anxiety symptoms as compared to CBT-I at post-intervention and 3-month follow-up.
- Being tested
- CBT-I, CBT-I combined ACT
- Keywords
- Insomnia, Anxiety, Youth
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IBehavioural
The CBT-I intervention will cover sleep education, stimulus control, sleep restriction, cognitive therapy and relaxation training.
CBT-I combined ACTBehavioural
In addition to the standard CBT-I components, mindfulness, thought diary, and other ACT components will be taught in the group.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Active comparator | A total of 6 sessions of face-to-face group CBT-I therapy will be provided. Each session will last 90-120 mins, with each group 8-10 subjects. Receives: Behavioral: CBT-I |
| CBT-I combined ACT | Experimental | A total of 6 sessions of face-to-face group CBT-I+ACT therapy will be provided. Each session will last 90-120 mins, with each group 8-10 subjects. Receives: Behavioral: CBT-I combined ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of anxiety symptoms and severity
General Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptoms and severity.
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Severity of anxiety symptoms
Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety symptoms.
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Clinician-rated severity of anxiety symptoms
Hamilton Anxiety Rating Scale (HAM-A) will be used to assess anxiety symptoms.
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary outcomes (13)
Severity of insomnia symptoms
Insomnia Severity Index (ISI) will be used to measure the severity of insomnia symptoms.
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Sleep-wake pattern
Youths will be asked to keep a sleep diary to chart their daily sleep-wake pattern including sleep duration, wakeup time, bedtime and sleep latency
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Daytime sleepiness
Pediatric Daytime Sleepiness Scale (PDSS) will be used to assess adolescents' daytime sleepiness.
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Anxiety trait
The State-Trait Anxiety Inventory (STAI) will be used to measure anxiety trait
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Severity of depressive symptoms
Patient Health Questionnaire 9-item (PHQ-9) will be used to measure the severity of depressive symptoms.
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Faulty sleep-related beliefs and cognitions
Dysfunctional Beliefs and Attitudes about Sleep Scale-16-item (DBAS-16) will be used to measure faulty sleep-related beliefs and cognitions, which are cognitive aspects typically involved in the maintenance of insomnia.
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Frequency of an individual practice sleep hygiene
Sleep Hygiene Practice Scale (SHPS) will be used to measure the frequency of an individual practice sleep hygiene.
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Psychological flexibility and experiential avoidance
Acceptance and Action Questionnaire-II (AAQ-II) is related to the underlying ACT theory to measure psychological flexibility and experiential avoidance.
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Individual's state of arousal
Pre-Sleep Arousal Scale (PSAS) will be used to measure individual's state of arousal as one falls asleep.
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Tendency to ruminate
The Ruminative Responses Scale - short version (RRS-10) is a 10-item scale on a 4-likert scale. It measures the tendency to ruminate.
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Major life events and hassles
The Adolescent Stress Index (ASI), which was developed using a Hong Kong student sample, will be used to measure major life events and hassles
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Global cognitive appraisal of one's life satisfaction
The Satisfaction With Life Scale (SWLS): SWLS is a 5-item scale on a 7-Likert scale. It measures the global cognitive appraisal of one's life satisfaction.
Measured: Baseline, Postintervention (6 weeks), and 3-month follow up
Subjective well-being in the previous week
The International Positive and Negative Affect Schedule Short Form (IPANAS-SF) will be used to capture the subjective well-being in the previous week. It has 9 items on a 5-Likert scale with previous study demonstrating satisfactory internal consistency reliability and reasonable nomological validity in Chinese youth.
Measured: Baseline, Postintervention (6 weeks), and 3-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 posted5 Dec 2023
- Study start15 Dec 2023
- Primary completion15 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- 50 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
- NCT06156306
- Sponsor's protocol ID
- 20230914
- Status last verified
- Jul 2025
- First submitted
- 27 Nov 2023
- Last updated
- 10 Jul 2025
- 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 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of CBT-I and CBT-I Combined ACT for Insomnia and Anxiety Symptoms in Youth: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT06156306
- Acronym / sponsor ID
- 20230914
- Keywords
- Insomnia, Anxiety, Youth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Dec 2023 (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.
Insomnia in adolescents and youth is a long-standing public health concern due to its high prevalence and association with various physical and mental health problems. Insomnia and psychiatric disorders are highly comorbid and intercorrelated in adolescents. Among all mental disorders, anxiety has been shown to be have high comorbidity with insomnia, affecting approximately 30% of individuals. CBT for insomnia (CBT-I) has been shown to be effective in improving sleep complaints and short-term improvement in mood while previous systematic reviews of interventional studies have demonstrated the effectiveness of acceptance and commitment therapy (ACT) interventions in treating insomnia, both as a primary condition and with other physical and/or mental health comorbidities. This study aims to compare the effect of CBT-I and CBT-I combined ACT in improving anxiety symptoms in youth.
Detailed description
Insomnia and psychiatric disorders are highly comorbid and intercorrelated in adolescents. Among all mental disorders, anxiety has been shown to be have high comorbidity with insomnia, affecting approximately 30% of individuals. Moreover, approximately three-quarters of anxious youth also report sleep-related problems. Literature reviews have investigated the relationship and the shared underlying mechanisms between sleep and anxiety. Anxiety sensitivity and pre-sleep arousal have been found to play a critical role in difficulty initiating sleep, which is the most common insomnia symptoms in adolescent population, partially due their natural delay of circadian rhythm. The findings suggest shared neurological and cognitive features that may account for dysregulation of both sleep and affect. Management targeting both sleep and anxiety is recommended due to potentially higher treatment efficacy and cost-effectiveness.
Accumulating evidence supports the effectiveness of cognitive-behavioural therapy for insomnia (CBT-I) and acceptance and commitment therapy (ACT) for addressing sleep and mood problems in adolescents. However, Only a few studies have directly compared the effectiveness of CBT-I and ACT. Past studies have shown that both CBT-I and ACT were effective in treating insomnia in adults.
This current study aims to compare the effect of CBT-I and CBT-I combined ACT in improving anxiety symptoms in youth. The primary hypothesis is that subjects in CBT-I combined ACT will have fewer anxiety symptoms as compared to CBT-I at post-intervention and 3-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 |
|---|---|---|
| CBT-I | Active comparator | Behavioral: CBT-IA total of 6 sessions of face-to-face group CBT-I therapy will be provided. Each session will last 90-120 mins, with each group 8-10 subjects. |
| CBT-I combined ACT | Experimental | Behavioral: CBT-I combined ACTA total of 6 sessions of face-to-face group CBT-I+ACT therapy will be provided. Each session will last 90-120 mins, with each group 8-10 subjects. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Chinese youth aged 15-24 years old, ii. Presence of insomnia problems as defined by insomnia severity index (ISI) using cut-off of 9, which has been locally validated cut off for detecting clinical insomnia), iii. Presence of anxiety features as defined by General Anxiety Disorder-7 (GAD-7) using cut-off of 10 for detecting clinical anxiety, iv. Ability to listen, speak, and read Chinese and Cantonese, and v. Written informed consent of participation into the study is given by youth and his/her parent's if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old vi. Possession of smartphone
Key exclusion criteria (2 listed)
- A youth would be excluded from the study if meeting one or more of the following criteria:
- A clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability ii. Having a diagnosed sleep disorder (e.g. delayed sleep phase and narcolepsy) that may potentially contribute to the disruption of sleep quantity and quality as determined by validated Diagnostic Interview for Sleep Patterns and Disorders (DISP) iii. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by The Structured Clinical Interview (SCID) iv. Currently receiving psychological treatment and/or pharmacological treatment for insomnia or anxiety disorder.
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 |
|---|---|---|
| CBT-IThe CBT-I intervention will cover sleep education, stimulus control, sleep restriction, cognitive therapy and relaxation training. | Behavioural | CBT-I |
| CBT-I combined ACTIn addition to the standard CBT-I components, mindfulness, thought diary, and other ACT components will be taught in the group. | Behavioural | CBT-I combined ACT |
Primary outcome
Severity of anxiety symptoms and severity
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
General Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptoms and severity.
Severity of anxiety symptoms
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety symptoms.
Clinician-rated severity of anxiety symptoms
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Hamilton Anxiety Rating Scale (HAM-A) will be used to assess anxiety symptoms.
13 secondary outcomes
Severity of insomnia symptoms
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Sleep-wake pattern
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Daytime sleepiness
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Anxiety trait
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Severity of depressive symptoms
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Faulty sleep-related beliefs and cognitions
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Frequency of an individual practice sleep hygiene
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Psychological flexibility and experiential avoidance
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Individual's state of arousal
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Tendency to ruminate
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Major life events and hassles
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Global cognitive appraisal of one's life satisfaction
Time frame: Baseline, Postintervention (6 weeks), and 3-month follow up
Subjective well-being in the previous week
Time frame: Baseline, Postintervention (6 weeks), and 3-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.
- Individual participant dataSharing planned: No
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
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 CBT-I and CBT-I combined ACT in people with Insomnia and Anxiety, 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 2 inclusion and 2 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 (39710550, 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?
Severity of anxiety symptoms and severity (time frame: Baseline, Postintervention (6 weeks), and 3-month follow up). 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 10 Jul 2025.