InsomniaNCT07209969
CBT-I in Adolescents With ADHD
A study testing CBT-I group in people with Insomnia and ADHD, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by persistent patterns of inattention, hyperactivity, and impulsivity, affecting individuals across the lifespan. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- What is being tested?
- CBT-I group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Apr 2023to 31 Oct 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
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria: Adolescents aged 11-18 years old meeting the following inclusion criteria were invited to take part in the present study:
- Having a clinical diagnosis of ADHD made by health care professionals (psychiatrist, clinical psychologist, or educational psychologist) based on self-report;
- a DSM-5 diagnosis of insomnia disorder, and a score on ISI ≥ 9 (suggested cut-off for adolescents) (Chung et al., 2011);
- Those who agreed to keep the same dosage of medication throughout the study up till completion of follow up assessments.
Exclusion Criteria: Adolescents were excluded if they met any of the following criteria:
- A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, autism spectrum disorders, 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, based on self-reported medical history;
- On an optimal dosage of psychostimulant or nonstimulant ADHD medications for less than a month;
- 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 pharmacological and psychological treatment for insomnia;
- With hearing or speech deficit.
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 & 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 Randomised Controlled Trial
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by persistent patterns of inattention, hyperactivity, and impulsivity, affecting individuals across the lifespan. While the core symptoms of ADHD are well-documented, emerging research has shed light on the prevalence of comorbid sleep disturbances, particularly insomnia, among adolescents with ADHD. The co-occurrence of ADHD and insomnia can exacerbate cognitive and emotional difficulties, impacting various aspects of daily functioning. Cognitive-Behavioral Therapy for Insomnia (CBT-I) has proven effective in addressing sleep-related difficulties in various populations. However, there is a paucity of research specifically examining the efficacy of CBT-I in adolescents with ADHD. To date, there was only one pilot single-arm sleep intervention study conducted in adolescents with ADHD (Becker et al., 2021) and one randomized controlled trial of sleep intervention in adolescents with ADHD that is still undergoing data collection (Keuppens et al., 2023). Given the lack of research on the intervention for insomnia in the context of ADHD, this study aimed to evaluate the efficacy of CBT-I on adolescents with ADHD in insomnia symptoms, sleep related cognitions and practices, ADHD severity, emotion regulation ability, and depressive and anxiety symptoms.
Read the detailed description
An assessor-blind, parallel-group, randomised controlled trial will be conducted in adolescents with comorbid ADHD and insomnia. Eligible participants will be randomised to either CBT-I group (intervention) or treatment-as-usual (TAU) control group. Assessments will be conducted at baseline, one-week post-treatment, and post-treatment 3-month. 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 group
- 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 groupBehavioural
Refer to the arm description
| Study group | Role | What they receive |
|---|---|---|
| CBT-I group | Experimental | The intervention for the CBT-I group will involve five weekly 60-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: psychoeducation about sleep, circadian rhythm, sleep hygiene, sleep restriction, stimulus control, cognitive restructuring, and relaxation techniques. Receives: Behavioral: CBT-I group |
| TAU 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, one-week post-treatment and 3 month post-treatment
Secondary outcomes (6)
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 3 month post-treatment
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 3 month post-treatment
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 3 month post-treatment
Change in anxiety symptoms
The Generalized Anxiety Disorder 7-item scale (GAD-7) will be used to measure generalized anxiety symptoms in the past 2 weeks
Measured: Baseline, one-week post-treatment and 3 month post-treatment
Change in depressive symptoms
The Patient Health Questionnaire - 9 (PHQ-9) will be used to measure the presence and severity of depression in the past 2 weeks.
Measured: Baseline, one-week post-treatment and 3 month post-treatment
Change in emotion regulation ability
The Difficulty in Emotion Regulation Scale (DERS; (Gratz \& Roemer, 2004) will be used to assess six domains of emotion regulation ability.
Measured: Baseline, one-week post-treatment and 3 month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Apr 2023 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Why it stopped: This entry was created by mistake.
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
- 0 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
- NCT07209969
- Sponsor's protocol ID
- KW/FR-21-131(163-09)
- Status last verified
- Jun 2026
- First submitted
- 29 Sep 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 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 Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07209969
- Acronym / sponsor ID
- KW/FR-21-131(163-09)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This entry was created by mistake.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Kwai Chung Hospital
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 7 Oct 2025 (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.
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by persistent patterns of inattention, hyperactivity, and impulsivity, affecting individuals across the lifespan. While the core symptoms of ADHD are well-documented, emerging research has shed light on the prevalence of comorbid sleep disturbances, particularly insomnia, among adolescents with ADHD. The co-occurrence of ADHD and insomnia can exacerbate cognitive and emotional difficulties, impacting various aspects of daily functioning. Cognitive-Behavioral Therapy for Insomnia (CBT-I) has proven effective in addressing sleep-related difficulties in various populations. However, there is a paucity of research specifically examining the efficacy of CBT-I in adolescents with ADHD. To date, there was only one pilot single-arm sleep intervention study conducted in adolescents with ADHD (Becker et al., 2021) and one randomized controlled trial of sleep intervention in adolescents with ADHD that is still undergoing data collection (Keuppens et al., 2023). Given the lack of research on the intervention for insomnia in the context of ADHD, this study aimed to evaluate the efficacy of CBT-I on adolescents with ADHD in insomnia symptoms, sleep related cognitions and practices, ADHD severity, emotion regulation ability, and depressive and anxiety symptoms.
Detailed description
An assessor-blind, parallel-group, randomised controlled trial will be conducted in adolescents with comorbid ADHD and insomnia. Eligible participants will be randomised to either CBT-I group (intervention) or treatment-as-usual (TAU) control group. Assessments will be conducted at baseline, one-week post-treatment, and post-treatment 3-month. 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 (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I group | Experimental | Behavioral: CBT-I groupThe intervention for the CBT-I group will involve five weekly 60-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: psychoeducation about sleep, circadian rhythm, sleep hygiene, sleep restriction, stimulus control, cognitive restructuring, and relaxation techniques. |
| TAU 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
- Accepted
- Age groups
- Child, Adult
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 groupRefer to the arm description | Behavioural | CBT-I group |
Primary outcome
Change in insomnia symptoms
Time frame: Baseline, one-week post-treatment and 3 month post-treatment
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.
6 secondary outcomes
Change in individual beliefs and attitude about sleep
Time frame: Baseline, one-week post-treatment and 3 month post-treatment
Change in adolescent sleep hygiene
Time frame: Baseline, one-week post-treatment and 3 month post-treatment
Change in ADHD symptoms (Self-report)
Time frame: Baseline, one-week post-treatment and 3 month post-treatment
Change in anxiety symptoms
Time frame: Baseline, one-week post-treatment and 3 month post-treatment
Change in depressive symptoms
Time frame: Baseline, one-week post-treatment and 3 month post-treatment
Change in emotion regulation ability
Time frame: Baseline, one-week post-treatment and 3 month post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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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 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?
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: withdrawn, as of the sponsor's last update on 22 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 was withdrawn before enrolling participants, so there are no results.
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, one-week post-treatment and 3 month post-treatment). 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 22 Jun 2026.