InsomniaNCT07021625
Use of CBT-I Based Chatbot for Assisted Treatment in Patients With Insomnia
A study testing Kunbot and Treatment as usual in people with Insomnia and Depression/Anxiety, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The recent lifestyle has put many people in a state of high stress, and the outbreak of COVID-19 in recent years has caused a steady increase in the number of people diagnosed with "Coronasomnia" (Covid-somnia) after recovering from the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Depression/Anxiety
- What is being tested?
- Kunbot and Treatment as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Oct 2023to 16 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Significant insomnia symptoms, including difficulty initiating sleep, difficulty maintaining sleep, early-morning awakening.
- The sleep difficulty occurs at least three nights per week and is present for at least 3 months.
- Patient possess a personal internet-connected cell phone or communicator.
Who cannot join
- Unwilling to participate in this research.
- Have poor cognitive function and cannot understand the content of the questionnaire; or cannot complete the test due to their physical condition
- Comorbid with schizophrenia, bipolar disorder, or substance use disorder
- Medications received have been adjusted in the past one month or will be adjusted during experiment
- Those who received in the past one month or will receive during experiment treatments such as: psychotherapy, cranial electrical stimulation, repetitive transcranial magnetic stimulation, transcranial direct current stimulation, or nutraceuticals aimed at improving mood or insomnia.
- Suicidal patients
Trial locations and contacts
1 site in 1 country.
About this study
The recent lifestyle has put many people in a state of high stress, and the outbreak of COVID-19 in recent years has caused a steady increase in the number of people diagnosed with "Coronasomnia" (Covid-somnia) after recovering from the disease. For reasons outlined above, a lot number of people were suffering from Insomnia. To propose some method to improve patients' sleep disorders become a popular research issue. The American Academy of Sleep Medicine strongly recommends using the Cognitive Behavioral Therapy for insomnia (CBT-I) method, one of the non-pharmacological treatments for insomnia. However, CBT-I is primarily a physical therapy, so patients may not be able to access this therapy due to time and location constraints. This project aims to combine the technology of Cognitive Behavioral Therapy for Insomnia (CBT-I) and chatbot to help insomnia patients learn more about their sleep habits and improve their sleep quality at home through remote access. Investigators will design a friendly chatbot based on the CBT-I concept to assist insomnia patients to improve their sleep quality and life quality.
This project will be executed at Taipei Municipal Wanfang Hospital. Patients of insomnia will be referred by the attending physician from outpatient clinic. It is estimated that 120 patients will be enrolled, 60 in the experimental group and 60 in the control group. The experimental group will receive four weeks of cognitive behavioral therapy for insomnia via a chatbot, while the control group will be treated as usual. Patients will be assessed for improvement in sleep severity at the end of four weeks and follow up after 12 weeks.
- Conditions
- Insomnia, Depression/Anxiety
- Being tested
- Kunbot, Treatment as usual
- Keywords
- Insomnia, Chatbot, CBT, Cognitive behavioral therapy, Cognitive behavioral therapy for insomnia, CBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KunbotDevice
A chatbot designed based on cognitive behavioral therapy for insomnia
Treatment as usualOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | four weeks of cognitive behavioral therapy for insomnia via a chatbot Receives: Device: Kunbot |
| Control group | Placebo comparator | treated as usual Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pittsburgh Sleep Quality Index
Value: 0~21, higher score means a worse outcome
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (4)
Patient Health Questionnaire
Value: 0~27, higher score means a worse outcome
Measured: From enrollment to the end of treatment at 4 weeks
Beck Depression Inventory
Value: 0~63, higher score means a worse outcome
Measured: From enrollment to the end of treatment at 4 weeks
Beck Anxiety Inventory
Value: 0~63, higher score means a worse outcome
Measured: From enrollment to the end of treatment at 4 weeks
Brief Symptom Rating Scale
Value: 0~20, higher score means a worse outcome
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start19 Oct 2023
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- The experimental group will receive four weeks of cognitive behavioral therapy for insomnia via a chatbot, while the control group will be treated as usual.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021625
- Sponsor's protocol ID
- N202306054
- Status last verified
- May 2025
- First submitted
- 3 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This project aims to combine the technology of Cognitive Behavioral Therapy for Insomnia (CBT-I) and chatbot to help insomnia patients learn more about their sleep habits and improve their sleep quality at home through remote access. We will design a friendly chatbot based on the CBT-I concept to assist insomnia patients to improve their sleep quality and life quality. Patients of insomnia will be referred by the attending physician from outpatient clinic. It is estimated that 120 patients will be enrolled, 60 in the experimental group and 60 in the control group. The experimental group will receive four weeks of cognitive behavioral therapy for insomnia via a chatbot, while the control group will be treated as usual. Patients will be assessed for improvement in sleep severity at the end of four weeks and follow up after 12 weeks.
Publications
Chiu YH, Lee YF, Lin HL, Cheng LC. Using cognitive behavioral therapy-based chatbots to alleviate symptoms of insomnia, depression, and anxiety: A randomized controlled trial. Health Informatics J. 2025 Oct-Dec;31(4):14604582251396428. doi: 10.1177/14604582251396428. Epub 2025 Nov 26.
PubMed 41296540
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of CBT-I Based Chatbot for Assisted Treatment in Patients With Insomnia
- ClinicalTrials.gov ID
- NCT07021625
- Acronym / sponsor ID
- N202306054
- Conditions
- Insomnia, Depression/Anxiety
- Keywords
- Insomnia, Chatbot, CBT, Cognitive behavioral therapy, Cognitive behavioral therapy for insomnia, CBT-I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 15 Jun 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.
The recent lifestyle has put many people in a state of high stress, and the outbreak of COVID-19 in recent years has caused a steady increase in the number of people diagnosed with "Coronasomnia" (Covid-somnia) after recovering from the disease. For reasons outlined above, a lot number of people were suffering from Insomnia. To propose some method to improve patients' sleep disorders become a popular research issue. The American Academy of Sleep Medicine strongly recommends using the Cognitive Behavioral Therapy for insomnia (CBT-I) method, one of the non-pharmacological treatments for insomnia. However, CBT-I is primarily a physical therapy, so patients may not be able to access this therapy due to time and location constraints. This project aims to combine the technology of Cognitive Behavioral Therapy for Insomnia (CBT-I) and chatbot to help insomnia patients learn more about their sleep habits and improve their sleep quality at home through remote access. Investigators will design a friendly chatbot based on the CBT-I concept to assist insomnia patients to improve their sleep quality and life quality.
This project will be executed at Taipei Municipal Wanfang Hospital. Patients of insomnia will be referred by the attending physician from outpatient clinic. It is estimated that 120 patients will be enrolled, 60 in the experimental group and 60 in the control group. The experimental group will receive four weeks of cognitive behavioral therapy for insomnia via a chatbot, while the control group will be treated as usual. Patients will be assessed for improvement in sleep severity at the end of four weeks and follow up after 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group will receive four weeks of cognitive behavioral therapy for insomnia via a chatbot, while the control group will be treated as usual.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Kunbotfour weeks of cognitive behavioral therapy for insomnia via a chatbot |
| Control group | Placebo comparator | Other: Treatment as usualtreated as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Significant insomnia symptoms, including difficulty initiating sleep, difficulty maintaining sleep, early-morning awakening.
- The sleep difficulty occurs at least three nights per week and is present for at least 3 months.
- Patient possess a personal internet-connected cell phone or communicator.
Key exclusion criteria (6 listed)
- Unwilling to participate in this research.
- Have poor cognitive function and cannot understand the content of the questionnaire; or cannot complete the test due to their physical condition
- Comorbid with schizophrenia, bipolar disorder, or substance use disorder
- Medications received have been adjusted in the past one month or will be adjusted during experiment
- Those who received in the past one month or will receive during experiment treatments such as: psychotherapy, cranial electrical stimulation, repetitive transcranial magnetic stimulation, transcranial direct current stimulation, or nutraceuticals aimed at improving mood or insomnia.
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 |
|---|---|---|
| KunbotA chatbot designed based on cognitive behavioral therapy for insomnia | Device | Experimental group |
| Treatment as usualTreatment as usual | Other | Control group |
Primary outcome
The Pittsburgh Sleep Quality Index
Time frame: From enrollment to the end of treatment at 4 weeks
Value: 0~21, higher score means a worse outcome
4 secondary outcomes
Patient Health Questionnaire
Time frame: From enrollment to the end of treatment at 4 weeks
Beck Depression Inventory
Time frame: From enrollment to the end of treatment at 4 weeks
Beck Anxiety Inventory
Time frame: From enrollment to the end of treatment at 4 weeks
Brief Symptom Rating Scale
Time frame: From enrollment to the end of treatment at 4 weeks
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 15 Jun 2025.
- Derived from this study: PubMed 41296540Chiu YH, Lee YF, Lin HL, Cheng LC. Using cognitive behavioral therapy-based chatbots to alleviate symptoms of insomnia, depression, and anxiety: A randomized controlled trial. Health Informatics J. 2025 Oct-Dec;31(4):14604582251396428. doi: 10.1177/14604582251396428. Epub 2025 Nov 26.
- Individual participant dataSharing planned: Yes. This project aims to combine the technology of Cognitive Behavioral Therapy for Insomnia (CBT-I) and chatbot to help insomnia patients learn more about their sleep habits and improve their sleep quality at home through remote access. We will design a friendly chatbot based on the CBT-I concept to assist insomnia patients to improve their sleep quality and life quality. Patients of insomnia will be referred by the attending physician from outpatient clinic. It is estimated that 120 patients will be enrolled, 60 in the experimental group and 60 in the control group. The experimental group will receive four weeks of cognitive behavioral therapy for insomnia via a chatbot, while the control group will be treated as usual. Patients will be assessed for improvement in sleep severity at the end of four weeks and follow up after 12 weeks.
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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 Kunbot and Treatment as usual in people with Insomnia and Depression/Anxiety, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 4 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 15 Jun 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
The Pittsburgh Sleep Quality Index (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07021625, which also lists 1 linked publication.
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 15 Jun 2025.