InsomniaNCT06593262
Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I)
A study testing app-based digital cognitive behavioral therapy for insomnia with AI chatbot and app-based digital cognitive behavioral therapy for insomnia without AI chatbot in people with Insomnia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Insomnia is a common sleep problem, which affects 9.4-38.2% of youths worldwide. Youth insomnia is linked to mental health problems, leading to substantial health and economic burden. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Insomnia
- What is being tested?
- app-based digital cognitive behavioral therapy for insomnia with AI chatbot and app-based digital cognitive behavioral therapy for insomnia without AI chatbot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Jul 2024to 23 Jun 2026
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Youth aged 18 to 25 years (as defined by WHO and evidence on AI mental health chatbots only available for individuals aged 18 years and older)
- Online informed consent of participation in the study should be provided
- Willing to comply with the requirements of the study protocol
- The presence of moderate to severe insomnia measured by a score of 15 or above on the Insomnia Severity Index (ISI)
- difficulties initiating, maintaining or nonrestorative sleep over a 1-month period
- Having access to a smartphone and consistent internet access for their smartphone
- Accepting the terms of service and privacy policies of the mobile apps used in the study for the delivery of the intervention
Who cannot join
- A history of any sleep disorder(s) (other than insomnia disorder) such as narcolepsy, obstructive sleep apnea, and restless legs syndrome
- A history of any mental retardation or neuropsychiatric disorder(s) (other than depression and anxiety disorders as they are the secondary outcomes) such as bipolar disorder, schizophrenia, and substance use disorder
- Presence of serious suicidality as evidenced by ideation with a plan or an attempt
- Receiving any pharmacological treatment (including sleep promoting agents)
- Receiving any structured psychotherapy
- Having shiftwork and trans-meridian travel in the past 3 months and during the intervention
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Psychiatry, the Chinese University of Hong Kong
Hong Kong
About this study
Official title: Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) With Artificial Intelligence Chatbot for Youth With Insomnia: An Assessor-blind, Randomized Controlled Trial
Insomnia is a common sleep problem, which affects 9.4-38.2% of youths worldwide. Youth insomnia is linked to mental health problems, leading to substantial health and economic burden. The project aims to conduct an assessor-blind, randomized controlled trial to evaluate the efficacy of an app-based CBT-I with AI chatbot in reducing insomnia symptoms among youths, compared to an app-based CBT-I without AI chatbot.
- Conditions
- Insomnia
- Being tested
- app-based digital cognitive behavioral therapy for insomnia with AI chatbot, app-based digital cognitive behavioral therapy for insomnia without AI chatbot
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
app-based digital cognitive behavioral therapy for insomnia with AI chatbotBehavioural
digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and patient-centered conversational agents
app-based digital cognitive behavioral therapy for insomnia without AI chatbotBehavioural
digital cognitive behavioral therapy for insomnia without two-way interactive, intelligent, and patient-centered conversational agents
| Study group | Role | What they receive |
|---|---|---|
| app-based digital cognitive behavioral therapy for insomnia with AI chatbot | Experimental | Not described Receives: Behavioral: app-based digital cognitive behavioral therapy for insomnia with AI chatbot |
| app-based digital cognitive behavioral therapy for insomnia without AI chatbot | Active comparator | Not described Receives: Behavioral: app-based digital cognitive behavioral therapy for insomnia without AI chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
the severity of insomnia symptoms
Measured: a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
Secondary outcomes (14)
sleep onset latency (SOL)
7-day sleep diary
Measured: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
wake after sleep onset (WASO)
7-day sleep diary
Measured: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
sleep efficiency (SE)
7-day sleep diary
Measured: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
Total sleep time (TST)
7-day sleep diary
Measured: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
The Pre-Sleep Arousal Scale
cognitive and somatic manifestations of arousal near bedtime Total score ranges from 8 to 40. Higher scores suggest increased cognitive and somatic arousal before sleep.
Measured: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
The Cognitive Failures Questionnaire
self-reported failures in perception, memory, and motor function Total score ranges from 0 to 100. Higher scores indicate more self-reported cognitive lapses.
Measured: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
Ford Insomnia Response to Stress Test
personal vulnerability to stress-related insomnia Total score ranges from 9 to 36. Higher scores suggest a greater likelihood of stress-induced insomnia.
Measured: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
reduced Horne and Östberg Morningness and Eveningness Questionnaire
Chronotype preference. Total score ranges from 4 to 25. Higher scores suggest a morning chronotype, while lower scores indicate an evening chronotype.
Measured: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
The Dysfunctional Beliefs and Attitudes about Sleep Scale
Faulty sleep-related beliefs and cognitions, which are cognitive aspects typically involved in the maintenance of insomnia. Total score range of 0 to 160, with higher scores indicating stronger dysfunctional beliefs about sleep.
Measured: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
Patient Health Questionnaire-9
The severity of depressive symptoms. Total score range of 0 to 27, where higher scores signify higher levels of depressive symptoms.
Measured: a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
General Anxiety Disorder-7
The severity of anxiety symptoms. Total score range of 0 to 21, with higher scores reflecting higher levels of anxiety symptoms
Measured: a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
The Sleep Hygiene Index
The practice of sleep hygiene behaviors. Total score ranges from 0 to 52. Higher scores reflect poorer sleep hygiene practices.
Measured: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
The Charlotte Attitudes Towards Sleep Scale
Perception and attitude towards sleep in youths. Total averaged score ranges from 1 to 7. Higher scores denote more positive attitudes about sleep.
Measured: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
The Multidimensional Fatigue Inventory
Five dimensions of fatigue (general fatigue, physical fatigues, mental fatigue, decreased motivation, and decreased activities).
Total score ranges from 20 to 100. Higher scores indicate greater fatigue levels.
Measured: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Jul 2024
- Primary completion23 Jun 2026
- Study completion23 Jun 2026
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim M. H. Li, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593262
- Sponsor's protocol ID
- 14106223
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) With Artificial Intelligence Chatbot for Youth With Insomnia: An Assessor-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06593262
- Acronym / sponsor ID
- 14106223
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 23 Jun 2026 (actual)
- First posted
- 19 Sep 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 is a common sleep problem, which affects 9.4-38.2% of youths worldwide. Youth insomnia is linked to mental health problems, leading to substantial health and economic burden. The project aims to conduct an assessor-blind, randomized controlled trial to evaluate the efficacy of an app-based CBT-I with AI chatbot in reducing insomnia symptoms among youths, compared to an app-based CBT-I without AI chatbot.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| app-based digital cognitive behavioral therapy for insomnia with AI chatbot | Experimental | Behavioral: app-based digital cognitive behavioral therapy for insomnia with AI chatbot |
| app-based digital cognitive behavioral therapy for insomnia without AI chatbot | Active comparator | Behavioral: app-based digital cognitive behavioral therapy for insomnia without AI chatbot |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Youth aged 18 to 25 years (as defined by WHO and evidence on AI mental health chatbots only available for individuals aged 18 years and older)
- Online informed consent of participation in the study should be provided
- Willing to comply with the requirements of the study protocol
- The presence of moderate to severe insomnia measured by a score of 15 or above on the Insomnia Severity Index (ISI)
- difficulties initiating, maintaining or nonrestorative sleep over a 1-month period
Key exclusion criteria (6 listed)
- A history of any sleep disorder(s) (other than insomnia disorder) such as narcolepsy, obstructive sleep apnea, and restless legs syndrome
- A history of any mental retardation or neuropsychiatric disorder(s) (other than depression and anxiety disorders as they are the secondary outcomes) such as bipolar disorder, schizophrenia, and substance use disorder
- Presence of serious suicidality as evidenced by ideation with a plan or an attempt
- Receiving any pharmacological treatment (including sleep promoting agents)
- Receiving any structured psychotherapy
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 |
|---|---|---|
| app-based digital cognitive behavioral therapy for insomnia with AI chatbotdigital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and patient-centered conversational agents | Behavioural | app-based digital cognitive behavioral therapy for insomnia with AI chatbot |
| app-based digital cognitive behavioral therapy for insomnia without AI chatbotdigital cognitive behavioral therapy for insomnia without two-way interactive, intelligent, and patient-centered conversational agents | Behavioural | app-based digital cognitive behavioral therapy for insomnia without AI chatbot |
Primary outcome
Insomnia Severity Index
Time frame: a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
the severity of insomnia symptoms
14 secondary outcomes
sleep onset latency (SOL)
Time frame: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
wake after sleep onset (WASO)
Time frame: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
sleep efficiency (SE)
Time frame: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
Total sleep time (TST)
Time frame: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
The Pre-Sleep Arousal Scale
Time frame: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
The Cognitive Failures Questionnaire
Time frame: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
Ford Insomnia Response to Stress Test
Time frame: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
reduced Horne and Östberg Morningness and Eveningness Questionnaire
Time frame: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
The Dysfunctional Beliefs and Attitudes about Sleep Scale
Time frame: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
Patient Health Questionnaire-9
Time frame: a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
General Anxiety Disorder-7
Time frame: a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
The Sleep Hygiene Index
Time frame: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
The Charlotte Attitudes Towards Sleep Scale
Time frame: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
The Multidimensional Fatigue Inventory
Time frame: a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)
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 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing app-based digital cognitive behavioral therapy for insomnia with AI chatbot and app-based digital cognitive behavioral therapy for insomnia without AI chatbot in people with Insomnia, 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 7 inclusion and 6 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline)). 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 Oct 2026.