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Use of CBT-I Based Chatbot for Assisted Treatment in Patients With Insomnia

Use of CBT-I Based Chatbot for Assisted Treatment in Patients With Insomnia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07021625
Enrollment
72
Registered
2025-06-15
Start date
2023-10-19
Completion date
2024-01-16
Last updated
2025-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression/Anxiety, Insomnia

Keywords

Insomnia, Chatbot, CBT, Cognitive behavioral therapy, Cognitive behavioral therapy for insomnia, CBT-I

Brief 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. 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.

Interventions

DEVICEKunbot

A chatbot designed based on cognitive behavioral therapy for insomnia

OTHERTreatment as usual

Treatment as usual

Sponsors

Taipei Medical University WanFang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥ 18 2. 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. 3. Patient possess a personal internet-connected cell phone or communicator.

Exclusion criteria

1. Unwilling to participate in this research. 2. Have poor cognitive function and cannot understand the content of the questionnaire; or cannot complete the test due to their physical condition 3. Comorbid with schizophrenia, bipolar disorder, or substance use disorder 4. Medications received have been adjusted in the past one month or will be adjusted during experiment 5. 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. 6. Suicidal patients

Design outcomes

Primary

MeasureTime frameDescription
The Pittsburgh Sleep Quality IndexFrom enrollment to the end of treatment at 4 weeksValue: 0\ 21, higher score means a worse outcome

Secondary

MeasureTime frameDescription
Patient Health QuestionnaireFrom enrollment to the end of treatment at 4 weeksValue: 0\ 27, higher score means a worse outcome
Beck Depression InventoryFrom enrollment to the end of treatment at 4 weeksValue: 0\ 63, higher score means a worse outcome
Beck Anxiety InventoryFrom enrollment to the end of treatment at 4 weeksValue: 0\ 63, higher score means a worse outcome
Brief Symptom Rating ScaleFrom enrollment to the end of treatment at 4 weeksValue: 0\ 20, higher score means a worse outcome

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026