CBT-I Chatbot for Youth

NCT05769231 | Withdrawn

• 1 other identifier: KPF22GWP14
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Chatbot; Youth; Insomnia; CBT-I; RCT

Outcome Measures

Primary Outcomes (1)

• The Insomnia Severity Index (ISI)

  The Insomnia Severity Index (ISI) will be used to measure insomnia symptoms in the previous month. ISI includes 7 items with a five-point Likert format (0 = not at all to 4 = very much). The total score ranges from 0 to 28. A score ≥ 8 indicates clinically significant insomnia in Chinese adolescents (sensitivity = 87%, specificity = 75%). The Cronbach's alpha and the test-retest reliability of ISI were 0.83 and 0.79, respectively.

  10-20 minutes

Secondary Outcomes (4)

• The reduced Horne and Östberg Morningness and Eveningness Questionnaire (rMEQ)

  10-20 minutes

• The Patient Health Questionnaire-9 (PHQ-9)

  10-20 minutes

• Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16)

  10-20 minutes

• Sleep Hygiene Index (SHI)

  10-20 minutes

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavioral: Cognitive Behavioral Therapy for Insomnia in Chatbot

Control group

NO INTERVENTION

Waitlist control

Interventions

Cognitive Behavioral Therapy for Insomnia in Chatbot 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: March 6, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share