The goal of this clinical trial is to evaluate whether a virtually embodied artificial intelligence (AI) agent delivered via VR-enhanced digital cognitive behavioral therapy for insomnia (dCBT-I) can improve insomnia outcomes and treatment adherence in adults with insomnia.
The main questions it aims to answer are:
\- Does VR-enhanced dCBT-I with an embodied AI agent lead to greater improvements in insomnia symptoms compared to app-based dCBT-I with an AI chatbot at post-intervention and 3-month follow-up?
Researchers will compare VR-enhanced dCBT-I with an embodied AI agent to app-based dCBT-I with an AI chatbot to see if the VR-enhanced intervention results in significantly improved clinical outcomes and adherence.
Participants will:
* Be randomly assigned to either the VR-enhanced AI agent intervention group or the app-based AI chatbot control group * Complete a digital cognitive behavioral therapy for insomnia (dCBT-I) program with either a virtually embodied AI agent (VR-based) or a chatbot-based application * Undergo assessments at baseline, post-intervention, and 3-month follow-up
Adults of Chinese ethnicity, aged between 18 and 65 years.
Presence of insomnia, as indicated by a score of 10 or higher on the ISI.
Meeting the DSM-IV-TR diagnostic criteria for insomnia disorder. The 1-month duration criterion in DSM-IV-TR rather than the 3-month criterion in DSM-V is adopted to broaden the clinical relevance of the study findings.
Willing to provide online informed consent to participate in the study.
A current or history of any sleep disorders other than insomnia disorder, such as narcolepsy, obstructive sleep apnea, and restless legs syndrome.
A current or history of mental retardation or neuropsychiatric disorders other than depression or anxiety or stress disorders (as they are considered treatment outcomes), including bipolar disorder, schizophrenia, and substance use disorder.
Presence of serious suicidality, demonstrated by ideation with a plan or a previous suicide attempt.
Currently receiving long-term pharmacological treatment, including sleep-promoting agents.
Parallel
App-based dCBT-I with AI chatbot
BehavioralDigital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents
VR-enhanced dCBT-I with embodied AI agent
BehavioralDigital cognitive behavioral therapy for insomnia delivered in virtual reality with a two-way interactive, virtually embodied, and intelligent AI agent.
Insomnia Severity Index
the severity of insomnia symptoms
Insomnia Module in the Diagnostic Interview for Sleep Disorder (DISP)
the severity of insomnia symptoms
Sleep onset latency (SOL)
7-day sleep diary
Wake after sleep onset (WASO)
7-day sleep diary
Sleep efficiency (SE)
7-day sleep diary
Total sleep time (TST)
7-day sleep diary
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This trial is not recruiting at the moment. You can still explore other options:
