InsomniaNCT06351930
CBT for Insomnia in Adolescents With ADHD
A study testing CBT-I + UC group in people with Insomnia and ADHD, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
Insomnia and attention deficit hyperactivity disorder (ADHD) are highly comorbid conditions with an intricate, bidirectional relationship. In particular, insomnia and ADHD often co-occur, with 22.9-34.6% of adolescents with insomnia having clinically significant ADHD, and 22-33.5% of adolescents with ADHD experiencing… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- What is being tested?
- CBT-I + UC group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Jun 2023to 5 Sep 2025
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cantonese-speaking adolescent aged 12-18 years old;
- A diagnosis of ADHD as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV);
- Having a DSM-5 diagnosis of insomnia disorder and with a score on Insomnia Severity Index (ISI) ≥ 9 (suggested cut-off for adolescents);
- 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;
- Those who are not on ADHD medication or have been stabilized on psychostimulant or nonstimulant ADHD medications (maintaining the optimal medication dosage for at least 6 months).
Who cannot join
- A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, autism spectrum disorder, organic mental disorders, or intellectual disabilities;
- Having a prominent medical condition known to interfere with sleep continuity and quality (e.g., severe 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;
- Concurrent, regular use of psychotropic medications(s) known to affect sleep continuity and quality (e.g., hypnotics, steroids), except for the use of psychostimulant medication for ADHD;
- Receiving ongoing psychological treatment for sleep problems;
- With hearing or speech deficit;
- In the opinion of the research clinician, having a clinically significant suicidality (e.g., with suicidal ideation with a plan or a suicide attempt in the recent one month), and/or endorsing "nearly everyday" for item 9 (suicidal thoughts) in the Patient Health Questionnaire - 9 (PHQ-9).
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital
Hong Kong
Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong
About this study
Official title: Efficacy of Cognitive Behaviour Therapy for Insomnia (CBT-I) in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD): A Randomized Controlled Trial
Insomnia and attention deficit hyperactivity disorder (ADHD) are highly comorbid conditions with an intricate, bidirectional relationship. In particular, insomnia and ADHD often co-occur, with 22.9-34.6% of adolescents with insomnia having clinically significant ADHD, and 22-33.5% of adolescents with ADHD experiencing comorbid insomnia symptoms. Insomnia is not only associated with increased ADHD severity, but also linked to an increased risk for other mental health problems and poorer treatment response in young people with ADHD. Behavioural sleep interventions have shown promise in improving sleep in young children with comorbid ADHD and insomnia. Nonetheless, when treating adolescent insomnia, especially those with ADHD, there is a need to consider the unique sleep and circadian features as well as psychosocial factors associated with not only ADHD but also adolescence, a challenging developmental stage. To date, there is a paucity of research to test the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in adolescents with comorbid ADHD and insomnia. To address the limitations in the existing literature, this study aims to conduct a randomised controlled trial (RCT) to examine the effects of CBT-I relative to a usual care (UC) condition in adolescents with ADHD, on improving sleep and ADHD symptoms, and other clinical and daytime symptoms, as well as overall functional improvement.
Read the detailed description
A parallel-group, randomised controlled trial will be conducted in adolescents with comorbid ADHD and insomnia. Eligible participants will be randomised to either CBT-I + UC or UC condition. Assessments will be conducted at baseline, one-week post-treatment, and post-treatment 3-month. A random subset of the sample (estimated 15 participants per group) will be assessed for sleep objectively using actigraphy for 7 consecutive days at baseline and one-week post-treatment. Participants in the control group will be offered CBT-I after 3-month follow-up. During the study period, all the participants will continue their regular clinical follow-ups with their attending psychiatrist for the prescription of psychotropic medication(s), if needed, for managing their ADHD and mental health condition. Prescription of any psychotropic medications of each participant during the trial will be reviewed and documented at baseline and at each follow-up.
- Being tested
- CBT-I + UC group
- Keywords
- Insomnia, ADHD, Adolescents, Youth, CBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-I + UC groupBehavioural
Refer to the arm description
| Study group | Role | What they receive |
|---|---|---|
| cognitive behaviour therapy for insomnia (CBT-I) + usual care (UC) group | Experimental | The intervention for the CBT-I + UC group will involve five weekly 50-minute individual, face-to-face sessions of CBT-I. The treatment components aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia whilst considering the clinical context of ADHD and include: psycho-education about ADHD, sleep, circadian rhythm and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention. Receives: Behavioral: CBT-I + UC group |
| UC group | No intervention | Participants will continue their usual clinical follow-up and receive standard treatment at the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Symptoms
Insomnia symptoms measured by Insomnia Severity Index (ISI). ISI is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
Measured: Baseline, week 2&4 of the intervention, one-week post-treatment and post-treatment 3 month.
Secondary outcomes (17)
Change in ADHD Symptoms (Self-report)
The Adult ADHD Self-Report Scale (ASRS) v1.1 Symptom Checklist is an 18-item self-administered questionnaire to screen for ADHD symptoms in both community surveys and clinical settings based on criteria of the DSM-IV-TR. The questionnaire asks participants to rate how often a symptom of inattention or hyperactivity has occurred during the past 6 months using a scale from 0 (never) to 4 (very often). The total score on this scale can range from 0 to 72, with higher scores indicating more ADHD symptomology.
Measured: Baseline, one-week post-treatment and post-treatment 3 month
Change in Internalising and Externalising Symptoms (Parent-rated)
The Strengths and Difficulties Questionnaire (SDQ) - parent report is a widely used and validated screening questionnaire to measure emotional and behavioural problems in adolescents. It consists of 25 items covering five subscales relating to emotional problems, peer problems, conduct problems, hyperactivity, and prosocial behaviour. A higher score of the scales indicates a higher severity of the problem, except for prosocial behaviour scale.
Measured: Baseline, one-week post-treatment and post-treatment 3 month
Change in depressive symptoms (Self-report)
Patient Health Questionnaire - 9 (PHQ9) consists of nine items to assess the frequency of depressive symptoms in the past 2 weeks. Higher scores suggest more severe depressive symptoms.
Measured: Baseline, one-week post-treatment and post-treatment 3 month
Change in anxiety symptoms (Self-report)
Generalized Anxiety Disorder 7-item scale (GAD-7) is a self-report measure of generalised anxiety symptoms in the past 2 weeks. Higher scores suggest more severe anxiety symptoms.
Measured: Baseline, one-week post-treatment and post-treatment 3 month
Change in 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, one-week post-treatment and post-treatment 3 month
Change in 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, one-week post-treatment and post-treatment 3 month
Change in 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, one-week post-treatment and post-treatment 3 month
Change in 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, one-week post-treatment and post-treatment 3 month
Change in 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, one-week post-treatment and post-treatment 3 month
Change in Objective Sleep Measures - Time in Bed (TIB)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: time in bed (TIB) in hours. A subset of sample will complete actigraphic assessment.
Measured: Baseline and one-week post-treatment
Change in Objective Sleep Measures - Total Sleep Time (TST)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: total sleep time (TST) in hours. A subset of sample will complete actigraphic assessment.
Measured: Baseline and one-week post-treatment
Change in Objective Sleep Measures - Sleep Onset Latency (SOL)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep onset latency (SOL) in mins. A subset of sample will complete actigraphic assessment.
Measured: Baseline and one-week post-treatment
Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: wake after sleep onset (WASO) in mins. A subset of sample will complete actigraphic assessment.
Measured: Baseline and one-week post-treatment
Change in Objective Sleep Measures - Sleep Efficiency (SE)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, %. A subset of sample will complete actigraphic assessment.
Measured: Baseline and one-week post-treatment
Change in Individual Beliefs and Attitude 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, one-week post-treatment and post-treatment 3 month
Change in Adolescent Sleep Hygiene
The Revised Adolescents Sleep Hygiene Scale (ASHSr) is used to measure adolescent sleep hygiene. It comprises 33 self-report items, categorizing into six subscales: physiological, sleep environment, cognitive/emotional, sleep stability, daytime sleep, and behavioral arousal. Adolescents rate the frequency of their sleep-related behaviors over the past month using a 6-point scale, where 1 corresponds to "always" and 6 to "never." Subscale scores are computed using means, and these scores range from 1 to 6. Higher scores on the subscales indicate better sleep hygiene.
Measured: Baseline, one-week post-treatment and post-treatment 3 month
Change in 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, one-week post-treatment and post-treatment 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Jun 2023
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
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
- Model description
- A randomised, parallel group controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Kwai Chung Hospital
- Responsible party
- Principal investigator, Dr. Shirley Xin Li, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351930
- Sponsor's protocol ID
- EA210473
- Status last verified
- Jun 2026
- First submitted
- 1 Apr 2024
- Last updated
- 17 Jun 2026
- 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cognitive Behaviour Therapy for Insomnia (CBT-I) in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06351930
- Acronym / sponsor ID
- EA210473
- Keywords
- Insomnia, ADHD, Adolescents, Youth, CBT-I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Kwai Chung Hospital
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 8 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.
Insomnia and attention deficit hyperactivity disorder (ADHD) are highly comorbid conditions with an intricate, bidirectional relationship. In particular, insomnia and ADHD often co-occur, with 22.9-34.6% of adolescents with insomnia having clinically significant ADHD, and 22-33.5% of adolescents with ADHD experiencing comorbid insomnia symptoms. Insomnia is not only associated with increased ADHD severity, but also linked to an increased risk for other mental health problems and poorer treatment response in young people with ADHD. Behavioural sleep interventions have shown promise in improving sleep in young children with comorbid ADHD and insomnia. Nonetheless, when treating adolescent insomnia, especially those with ADHD, there is a need to consider the unique sleep and circadian features as well as psychosocial factors associated with not only ADHD but also adolescence, a challenging developmental stage. To date, there is a paucity of research to test the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in adolescents with comorbid ADHD and insomnia. To address the limitations in the existing literature, this study aims to conduct a randomised controlled trial (RCT) to examine the effects of CBT-I relative to a usual care (UC) condition in adolescents with ADHD, on improving sleep and ADHD symptoms, and other clinical and daytime symptoms, as well as overall functional improvement.
Detailed description
A parallel-group, randomised controlled trial will be conducted in adolescents with comorbid ADHD and insomnia. Eligible participants will be randomised to either CBT-I + UC or UC condition. Assessments will be conducted at baseline, one-week post-treatment, and post-treatment 3-month. A random subset of the sample (estimated 15 participants per group) will be assessed for sleep objectively using actigraphy for 7 consecutive days at baseline and one-week post-treatment. Participants in the control group will be offered CBT-I after 3-month follow-up. During the study period, all the participants will continue their regular clinical follow-ups with their attending psychiatrist for the prescription of psychotropic medication(s), if needed, for managing their ADHD and mental health condition. Prescription of any psychotropic medications of each participant during the trial will be reviewed and documented at baseline and at each follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A randomised, parallel group controlled trial
| Arm | Type | Receives |
|---|---|---|
| cognitive behaviour therapy for insomnia (CBT-I) + usual care (UC) group | Experimental | Behavioral: CBT-I + UC groupThe intervention for the CBT-I + UC group will involve five weekly 50-minute individual, face-to-face sessions of CBT-I. The treatment components aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia whilst considering the clinical context of ADHD and include: psycho-education about ADHD, sleep, circadian rhythm and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention. |
| UC group | No intervention | –Participants will continue their usual clinical follow-up and receive standard treatment at the clinic. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Cantonese-speaking adolescent aged 12-18 years old;
- A diagnosis of ADHD as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV);
- Having a DSM-5 diagnosis of insomnia disorder and with a score on Insomnia Severity Index (ISI) ≥ 9 (suggested cut-off for adolescents);
- 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;
Key exclusion criteria (7 listed)
- A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, autism spectrum disorder, organic mental disorders, or intellectual disabilities;
- Having a prominent medical condition known to interfere with sleep continuity and quality (e.g., severe 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;
- Concurrent, regular use of psychotropic medications(s) known to affect sleep continuity and quality (e.g., hypnotics, steroids), except for the use of psychostimulant medication for ADHD;
- Receiving ongoing psychological treatment for sleep problems;
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-I + UC groupRefer to the arm description | Behavioural | cognitive behaviour therapy for insomnia (CBT-I) + usual care (UC) group |
Primary outcome
Change in Insomnia Symptoms
Time frame: Baseline, week 2&4 of the intervention, one-week post-treatment and post-treatment 3 month.
Insomnia symptoms measured by Insomnia Severity Index (ISI). ISI is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
17 secondary outcomes
Change in ADHD Symptoms (Self-report)
Time frame: Baseline, one-week post-treatment and post-treatment 3 month
Change in Internalising and Externalising Symptoms (Parent-rated)
Time frame: Baseline, one-week post-treatment and post-treatment 3 month
Change in depressive symptoms (Self-report)
Time frame: Baseline, one-week post-treatment and post-treatment 3 month
Change in anxiety symptoms (Self-report)
Time frame: Baseline, one-week post-treatment and post-treatment 3 month
Change in Sleep Diary Measure - Time in Bed (TIB)
Time frame: Baseline, one-week post-treatment and post-treatment 3 month
Change in Sleep Diary Measure - Total Sleep Time (TST)
Time frame: Baseline, one-week post-treatment and post-treatment 3 month
Change in Sleep Diary Measure - Sleep Onset Latency (SOL)
Time frame: Baseline, one-week post-treatment and post-treatment 3 month
Change in Sleep Diary Measure - Wake After Sleep Onset (WASO)
Time frame: Baseline, one-week post-treatment and post-treatment 3 month
Change in Sleep Diary Measure - Sleep Efficiency (SE)
Time frame: Baseline, one-week post-treatment and post-treatment 3 month
Change in Objective Sleep Measures - Time in Bed (TIB)
Time frame: Baseline and one-week post-treatment
Change in Objective Sleep Measures - Total Sleep Time (TST)
Time frame: Baseline and one-week post-treatment
Change in Objective Sleep Measures - Sleep Onset Latency (SOL)
Time frame: Baseline and one-week post-treatment
Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)
Time frame: Baseline and one-week post-treatment
Change in Objective Sleep Measures - Sleep Efficiency (SE)
Time frame: Baseline and one-week post-treatment
Change in Individual Beliefs and Attitude about Sleep
Time frame: Baseline, one-week post-treatment and post-treatment 3 month
Change in Adolescent Sleep Hygiene
Time frame: Baseline, one-week post-treatment and post-treatment 3 month
Change in Quality of Life
Time frame: Baseline, one-week post-treatment and post-treatment 3 month
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 17 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I + UC group in people with Insomnia and ADHD, run by The University of Hong Kong at 2 sites 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 6 inclusion and 7 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 in Insomnia Symptoms (time frame: Baseline, week 2&4 of the intervention, one-week post-treatment and post-treatment 3 month.). 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 17 Jun 2026.