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

NCT07021625 | Completed DMC

• 1 other identifier: N202306054
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Depression/Anxiety

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The Pittsburgh Sleep Quality Index

  Value: 0\~21, higher score means a worse outcome

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (4)

• Patient Health Questionnaire

  From enrollment to the end of treatment at 4 weeks

• Beck Depression Inventory

  From enrollment to the end of treatment at 4 weeks

• Beck Anxiety Inventory

  From enrollment to the end of treatment at 4 weeks

• Brief Symptom Rating Scale

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

four weeks of cognitive behavioral therapy for insomnia via a chatbot

Device: Kunbot

Control group

PLACEBO COMPARATOR

treated as usual

Other: Treatment as usual

Interventions

Kunbot DEVICE

A chatbot designed based on cognitive behavioral therapy for insomnia

Experimental group

Treatment as usual OTHER

Treatment as usual

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

WanFang Hospital

Taipei, Taiwan, 116, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 15, 2025
• Study Start: October 19, 2023
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: July 2023-December 2025

Locations

TW (1)