Mental HealthNCT07711769
Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems
A study testing Brief sleep health advice, 2 weeks of chatbot-based daily sleep diary and 10 weeks chatbot-based IM support in people with Mental Health, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to evaluate the feasibility, acceptability, and potential effectiveness of a nurse-led digital cognitive behavioral therapy for insomnia (dCBT-I) via large language model based-chatbot among university students with mental health problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Brief sleep health advice, 2 weeks of chatbot-based daily sleep diary and 10 weeks chatbot-based IM support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2026to 31 Oct 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Students aged ≥ 18 years from 22 local higher education institutions (University or Colleges) listed in Education Bureau.
- Screening score indicating mild to moderate anxiety or depression, defined as a GAD-7 score of 5-14 and/or a PHQ-9 score of 5-14 at baseline.
- Screened positive for insomnia symptoms using the Sleep Condition Indicator (SCI) and meeting DSM-5 diagnostic criteria for insomnia disorder.
- Reporting a self-reported sleep efficiency of less than 85% over the past month.
- Able to communicate in Chinese.
Who cannot join
- Participants who self-reported diagnosis of epilepsy, schizophrenia, or bipolar disorder
- Participants who self-reported current suicidal ideation with intent or a suicide attempt within the past 2 months
- Participants who self-reported current receipt of psychological or behavioral treatment for insomnia from a health professional
- Participants who self-reported participation in an online or digital insomnia treatment programme at the time of enrolment.
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
School of Public Health, The University of Hong Kong, 18/F, Metro South Tower 1, 39 Wong Chuk Hang Road, Wong Chuk Hang, Hong Kong
Hong Kong
Shengzhi Zhao, +852 6561 4500, lubabezz@connect.hku.hk
Tsz Kiu Chan, +852 5506 4711, natctk1@hku.hk
About this study
Official title: Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems: a Pilot Randomized Controlled Trial
This study aims to evaluate the feasibility, acceptability, and potential effectiveness of a nurse-led digital cognitive behavioral therapy for insomnia (dCBT-I) via large language model based-chatbot among university students with mental health problems.
Read the detailed description
This is a two-arm, parallel pilot randomized controlled trial recruiting 100 university students in Hong Kong with mild to moderate symptoms of depression or anxiety who also screen positive for insomnia symptoms. All participants will receive brief sleep health advice and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia. Participants in the intervention group will additionally receive 12 weeks of chatbot-delivered insomnia management intervention, including 2 weeks of daily sleep diary monitoring and 10 weeks of nurse-led instant messaging support grounded in cognitive behavioral therapy for insomnia (CBT-I). The primary outcome is self-reported insomnia severity at 6-month follow-up. Secondary outcomes include health-related quality of life, sleep related quality of life, sleep effort, pre-sleep arousal, anxiety and depression assessed at 3 and 6 months. Analyses will be conducted on intention-to-treat basis.
- Conditions
- Mental Health
- Being tested
- Brief sleep health advice, 2 weeks of chatbot-based daily sleep diary, 10 weeks chatbot-based IM support
- Keywords
- Cognitive Behavioral Therapy for Insomnia, insomnia, large language model, chatbot, university student
- Medical subject headings
- Psychological Well-Being, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief sleep health adviceBehavioural
At baseline, both groups will receive a 1-on-1 brief sleep health advice developed using guidelines by U.S. Centers for Diseases Control and Prevention and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia.
2 weeks of chatbot-based daily sleep diaryBehavioural
Following randomization, participants in the intervention group will complete a 2-week chatbot-based daily sleep diary. Each morning (e.g., 8:00 am), participants will be prompted via Whatsapp message delivered by chatbot to report key sleep parameters from the previous night, including bedtime, wake time, sleep onset latency, number and duration of nocturnal awakenings, total sleep time, and perceived sleep quality. The collected sleep diary data will be processed by the chatbot to generate tailored and personalized feedback, supporting individualized sleep recommendations and behavioral adjustments. At the initiation of the intervention, participants will also complete a brief baseline questionnaire to establish personalized treatment goals related to sleep improvement. Throughout the intervention period, participants will have continuous access to chatbot-delivered support, including adaptive guidance based on diary inputs, reinforcement of recommended sleep strategies, and progress
10 weeks chatbot-based IM supportBehavioural
Participants in the intervention group will also receive cognitive behavioral therapy for insomnia (CBT-I) delivered via an LLM-based chatbot through WhatsApp over a 10-week period. The intervention is fully automated and available 24/7, with underlying algorithms enabling the delivery of information, therapeutic support, and advice in a personalized and adaptive manner, informed by participants' ongoing inputs and interaction patterns. The intervention will be structured into 20 chatbot-delivered instant messaging (2 pieces per week). The therapeutic content is adapted from established CBT-I manuals and led by research nurse, incorporating evidence-based behavioral, cognitive, and educational components. Behavioral strategies include sleep restriction, stimulus control, and relaxation techniques. Cognitive components comprise paradoxical intention, cognitive restructuring, mindfulness-based techniques, positive imagery, and strategies for "putting the day to rest." Educational compone
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Brief sleep health advice; Behavioral: 2 weeks of chatbot-based daily sleep diary; Behavioral: 10 weeks chatbot-based IM support |
| Control group | Active comparator | Not described Receives: Behavioral: Brief sleep health advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported insomnia severity
Assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item self-report instrument that evaluates both nocturnal and daytime symptoms of insomnia, with total scores ranging from 0 to 28, higher scores indicate greater insomnia severity.
Measured: 6-month follow-up
Secondary outcomes (6)
Health-related quality of life
Assessed using 36-Item Short Form Health Survey [SF-36]. The SF-36 is a 36-item self-reported instrument that measures both Physical Component Scores and Mental Component Scores, with scores ranging from 0 to 100; higher scores indicate better health-related quality of life.
Measured: 3- and 6-month follow-ups
Sleep-related quality of life
Assessed using Glasgow Sleep Impact Index [GSII]. The GSII is a 7-item self-report instrument that evaluates the sleep-related quality of life, with total scores ranging from 0 to 28, higher scores indicate lower level of sleep-related quality of life.
Measured: 3- and 6-month follow-ups
Depressive symptoms
Assessed using Patient Health Questionnaire-9 [PHQ-9]. The PHQ-9 is a 9-item self-report instrument that evaluates frequency and severity of depressive symptoms, with total scores ranging from 0 to 27, higher scores indicate higher level of depression.
Measured: 3- and 6-month follow-ups
Anxiety symptoms
Assessed using Generalized Anxiety Disorder-7 [GAD-7]. The GAD-7 is a 7-item self-report instrument that evaluates the frequency and severity of anxious symptoms, with total scores ranging from 0 to 21, higher scores indicate higher level of anxiety.
Measured: 3- and 6-month follow-ups
Sleep effort
Assessed using Glasgow Sleep Effort Scale [GSES]. The GSES is a 7-item self-reported instrument, with scores ranging from 0 to 14, higher scores indicate greater sleep effort.
Measured: 3- and 6-month follow-ups
Pre-sleep arousal
Assessed using Pre-Sleep Arousal Scale [PSAS]. The PSAS is a 16-item self-reported instrument consists of two subscales (cognitive arousal and somatic arousal), with scores ranging from 8 to 40 on each subscale, higher scores indicate greater pre-sleep arousal.
Measured: 3- and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengzhi Zhao, The University of Hong Kong
- Investigators
- Shengzhi Zhao, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711769
- Sponsor's protocol ID
- dCBT-I in University Students
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07711769
- Acronym / sponsor ID
- dCBT-I in University Students
- Conditions
- Mental Health
- Keywords
- Cognitive Behavioral Therapy for Insomnia, insomnia, large language model, chatbot, university student
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 17 Jul 2026 (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.
This study aims to evaluate the feasibility, acceptability, and potential effectiveness of a nurse-led digital cognitive behavioral therapy for insomnia (dCBT-I) via large language model based-chatbot among university students with mental health problems.
Detailed description
This is a two-arm, parallel pilot randomized controlled trial recruiting 100 university students in Hong Kong with mild to moderate symptoms of depression or anxiety who also screen positive for insomnia symptoms. All participants will receive brief sleep health advice and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia. Participants in the intervention group will additionally receive 12 weeks of chatbot-delivered insomnia management intervention, including 2 weeks of daily sleep diary monitoring and 10 weeks of nurse-led instant messaging support grounded in cognitive behavioral therapy for insomnia (CBT-I). The primary outcome is self-reported insomnia severity at 6-month follow-up. Secondary outcomes include health-related quality of life, sleep related quality of life, sleep effort, pre-sleep arousal, anxiety and depression assessed at 3 and 6 months. Analyses will be conducted on intention-to-treat basis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Brief sleep health advice, Behavioral: 2 weeks of chatbot-based daily sleep diary, Behavioral: 10 weeks chatbot-based IM support |
| Control group | Active comparator | Behavioral: Brief sleep health advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Students aged ≥ 18 years from 22 local higher education institutions (University or Colleges) listed in Education Bureau.
- Screening score indicating mild to moderate anxiety or depression, defined as a GAD-7 score of 5-14 and/or a PHQ-9 score of 5-14 at baseline.
- Screened positive for insomnia symptoms using the Sleep Condition Indicator (SCI) and meeting DSM-5 diagnostic criteria for insomnia disorder.
- Reporting a self-reported sleep efficiency of less than 85% over the past month.
- Able to communicate in Chinese.
Key exclusion criteria (4 listed)
- Participants who self-reported diagnosis of epilepsy, schizophrenia, or bipolar disorder
- Participants who self-reported current suicidal ideation with intent or a suicide attempt within the past 2 months
- Participants who self-reported current receipt of psychological or behavioral treatment for insomnia from a health professional
- Participants who self-reported participation in an online or digital insomnia treatment programme at the time of enrolment.
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 |
|---|---|---|
| Brief sleep health adviceAt baseline, both groups will receive a 1-on-1 brief sleep health advice developed using guidelines by U.S. Centers for Diseases Control and Prevention and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia. | Behavioural | Control group, Intervention group |
| 2 weeks of chatbot-based daily sleep diaryFollowing randomization, participants in the intervention group will complete a 2-week chatbot-based daily sleep diary. Each morning (e.g., 8:00 am), participants will be prompted via Whatsapp message delivered by chatbot to report key sleep parameters from the previous night, including bedtime, wake time, sleep onset latency, number and duration of nocturnal awakenings, total sleep time, and perceived sleep quality. The collected sleep diary data will be processed by the chatbot to generate tailored and personalized feedback, supporting individualized sleep recommendations and behavioral adjustments. At the initiation of the intervention, participants will also complete a brief baseline questionnaire to establish personalized treatment goals related to sleep improvement. Throughout the intervention period, participants will have continuous access to chatbot-delivered support, including adaptive guidance based on diary inputs, reinforcement of recommended sleep strategies, and progress | Behavioural | Intervention group |
| 10 weeks chatbot-based IM supportParticipants in the intervention group will also receive cognitive behavioral therapy for insomnia (CBT-I) delivered via an LLM-based chatbot through WhatsApp over a 10-week period. The intervention is fully automated and available 24/7, with underlying algorithms enabling the delivery of information, therapeutic support, and advice in a personalized and adaptive manner, informed by participants' ongoing inputs and interaction patterns. The intervention will be structured into 20 chatbot-delivered instant messaging (2 pieces per week). The therapeutic content is adapted from established CBT-I manuals and led by research nurse, incorporating evidence-based behavioral, cognitive, and educational components. Behavioral strategies include sleep restriction, stimulus control, and relaxation techniques. Cognitive components comprise paradoxical intention, cognitive restructuring, mindfulness-based techniques, positive imagery, and strategies for "putting the day to rest." Educational compone | Behavioural | Intervention group |
Primary outcome
Self-reported insomnia severity
Time frame: 6-month follow-up
Assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item self-report instrument that evaluates both nocturnal and daytime symptoms of insomnia, with total scores ranging from 0 to 28, higher scores indicate greater insomnia severity.
6 secondary outcomes
Health-related quality of life
Time frame: 3- and 6-month follow-ups
Sleep-related quality of life
Time frame: 3- and 6-month follow-ups
Depressive symptoms
Time frame: 3- and 6-month follow-ups
Anxiety symptoms
Time frame: 3- and 6-month follow-ups
Sleep effort
Time frame: 3- and 6-month follow-ups
Pre-sleep arousal
Time frame: 3- and 6-month follow-ups
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 24 Jul 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.
Shengzhi Zhao principal investigator
The 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 Brief sleep health advice, 2 weeks of chatbot-based daily sleep diary and 10 weeks chatbot-based IM support in people with Mental Health, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 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?
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 Shengzhi Zhao (+852 6561 4500, lubabezz@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported insomnia severity (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.