Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems

Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems: a Pilot Randomized Controlled Trial

This study aims to evaluate the feasibility, acceptability, and potential effectiveness of a nurse-led digital cognitive behavioral therapy for insomnia (dCBT-I) via large language model based-chatbot among university students with mental health problems.

This is a two-arm, parallel pilot randomized controlled trial recruiting 100 university students in Hong Kong with mild to moderate symptoms of depression or anxiety who also screen positive for insomnia symptoms. All participants will receive brief sleep health advice and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia. Participants in the intervention group will additionally receive 12 weeks of chatbot-delivered insomnia management intervention, including 2 weeks of daily sleep diary monitoring and 10 weeks of nurse-led instant messaging support grounded in cognitive behavioral therapy for insomnia (CBT-I). The primary outcome is self-reported insomnia severity at 6-month follow-up. Secondary outcomes include health-related quality of life, sleep related quality of life, sleep effort, pre-sleep arousal, anxiety and depression assessed at 3 and 6 months. Analyses will be conducted on intention-to-treat basis.

Inclusion Criteria:

• Students aged ≥ 18 years from 22 local higher education institutions (University or Colleges) listed in Education Bureau.
• Screening score indicating mild to moderate anxiety or depression, defined as a GAD-7 score of 5-14 and/or a PHQ-9 score of 5-14 at baseline.
• Screened positive for insomnia symptoms using the Sleep Condition Indicator (SCI) and meeting DSM-5 diagnostic criteria for insomnia disorder.
• Reporting a self-reported sleep efficiency of less than 85% over the past month.
• Able to communicate in Chinese.

Exclusion Criteria:

• Participants who self-reported diagnosis of epilepsy, schizophrenia, or bipolar disorder
• Participants who self-reported current suicidal ideation with intent or a suicide attempt within the past 2 months
• Participants who self-reported current receipt of psychological or behavioral treatment for insomnia from a health professional
• Participants who self-reported participation in an online or digital insomnia treatment programme at the time of enrolment.