Clinical trial NCT07021625: Use of CBT-I Based Chatbot for Assisted Treatment in Patients With Insomnia
Official title: Use of CBT-I Based Chatbot for Assisted Treatment in Patients With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Depression/Anxiety
Keywords: Insomnia
Chatbot
CBT
Cognitive behavioral therapy
Cognitive behavioral therapy for insomnia
CBT-I
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Pittsburgh Sleep Quality Index
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Patient Health Questionnaire
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Beck Depression Inventory
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Beck Anxiety Inventory
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Brief Symptom Rating Scale
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: WanFang Hospital
Study officials:
References: