Efficacy of a Chatbot to Deliver Cognitive-behavioral Therapy for Insomnia in Youth: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 132
- Primary Endpoint
- The Insomnia Severity Index (ISI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Intervention group
Intervention: Cognitive Behavioral Therapy for Insomnia in Chatbot (Behavioral)
Control group
Waitlist control
Outcomes
Primary Outcomes
The Insomnia Severity Index (ISI)
Time Frame: 10-20 minutes
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.
Secondary Outcomes
- Sleep Hygiene Index (SHI)(10-20 minutes)
- 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)
Investigators
Tim M. H. Li
Research Assistant Professor
Chinese University of Hong Kong