CBT-I Chatbot for Youth

NCT ID: NCT05769231

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2025-01-31

Brief Summary

Insomnia is prevalent in youth, and it associates with depression and other psychiatric disorders, leading to increased mental health burden. Cognitive Behavioral Therapy for Insomnia (CBT-I) is recommended as first-line treatment for insomnia. Digital tools have been employed to automate mental health interventions, in order to address deterrents such as clinician shortage, limited appointment availability, high cost, and stigma of seeking help. Digital CBT-I is shown to be effective in treating insomnia. Future digital intervention will incorporate patient-centered design, input from key stakeholders, and new understandings of behavior change. Artificial Intelligence (AI)-powered chatbots are utilized in different industries for better customer experience. AI chatbot is also utilized in the mental health industry to extend the boundary of digital interventions from accommodating didactic and informational content to providing interactive, intelligent, and most importantly, patient-centered conversational agents. Some famous AI mental health chatbots in Western societies were developed to give tailored feedback, respond to emotions that a user expresses, and encourage users to complete an intervention. This study will investigate the effect of a CBT-I chatbot on insomnia to provide further evidence on mental health chatbot.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia in Chatbot

Intervention Type: BEHAVIORAL

Digital interventions can relieve the worldwide burden of mental disorders. The low set-up costs and barriers of online platforms make digital interventions very cost-effective. By using the Internet as a delivery medium, many people can enjoy unrestricted access to self-help information. Unlike traditional face-to-face intervention, the effects of digital self-help interventions are scalable. The current study attempts to extend the boundary of digital interventions from accommodating didactic and informational content to providing interactive, intelligent, and most importantly, patient-centered conversational agents. AI chatbots can provide suitable recommendations and training materials to users according to their behavioral, mental, and motivational readiness. Since existing AI chatbots are developed for Western societies, a culture-specific Chinese chatbot will fill the research and service gaps.

Control group

Waitlist control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioral Therapy for Insomnia in Chatbot

Digital interventions can relieve the worldwide burden of mental disorders. The low set-up costs and barriers of online platforms make digital interventions very cost-effective. By using the Internet as a delivery medium, many people can enjoy unrestricted access to self-help information. Unlike traditional face-to-face intervention, the effects of digital self-help interventions are scalable. The current study attempts to extend the boundary of digital interventions from accommodating didactic and informational content to providing interactive, intelligent, and most importantly, patient-centered conversational agents. AI chatbots can provide suitable recommendations and training materials to users according to their behavioral, mental, and motivational readiness. Since existing AI chatbots are developed for Western societies, a culture-specific Chinese chatbot will fill the research and service gaps.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• score 8 or higher on the Insomnia Severity Index (ISI)
• between 18 and 35 years old
• read and type Chinese
• own a smartphone
• have consistent internet access to their smartphone

Exclusion Criteria

• have a self-reported diagnosis of any psychiatric disorder(s)
• have been on regular medication(s) in the past month
• do not have instant messaging app(s) will be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Tim M. H. Li

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KPF22GWP14

Identifier Type: -

Identifier Source: org_study_id