Efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) with artificial intelligence chatbot for youth with insomnia: An assessor-blind, randomized controlled trial

Cognitive behavioral therapy for insomnia (CBT-I) is effective in improving insomnia and mental health among youths. However, high attrition and low adherence are challenging issues in the delivery of effective digital CBT-I. Artificial intelligence (AI) chatbots could extend the boundary of digital interventions from accommodating one-way didactic and informational content to providing two-way interactive, intelligent, and patient-centered conversational agents. Thus, we aim to conduct a randomized controlled trial to evaluate the efficacy of an app-based CBT-I with AI chatbot in reducing insomnia symptoms among youths, compared to an app-based CBT-I without AI chatbot. This study will confirm the efficacy of AI chatbots in improving insomnia and provide further evidence to support the effect of AI mental health chatbots in general.

- Youth aged 18 to 25 years
- Having insomnia (including difficulty in falling asleep, early morning awakening, or difficulty maintaining sleep at least 3 times/week in the past month)

Youths with insomnia will receive a 4-week app-based CBT-I program with or without an AI chatbot. Assessments will be performed at the baseline, 2-week interim, post-intervention, 3-month follow-up, and 6-month follow-up. Participants will receive an incentive of HK$700 if they are invited to perform all the above procedures.