Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brief sleep health advice, 2 weeks of chatbot-based daily sleep diary, 10 weeks chatbot-based IM support.
- Who it may be relevant to
- Registry conditions: Mental Health. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Behavioral Brief sleep health advice
At baseline, both groups will receive a 1-on-1 brief sleep health advice developed using guidelines by U.S. Centers for Diseases Control and Prevention and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia. - Behavioral 2 weeks of chatbot-based daily sleep diary
Following randomization, participants in the intervention group will complete a 2-week chatbot-based daily sleep diary. Each morning (e.g., 8:00 am), participants will be prompted via Whatsapp message delivered by chatbot to report key sleep parameters from the previous night, including bedtime, wake time, sleep onset latency, number and duration of nocturnal awakenings, total sleep time, and perceived sleep quality. The collected sleep diary data will be processed by the chatbot to generate tai - Behavioral 10 weeks chatbot-based IM support
Participants in the intervention group will also receive cognitive behavioral therapy for insomnia (CBT-I) delivered via an LLM-based chatbot through WhatsApp over a 10-week period. The intervention is fully automated and available 24/7, with underlying algorithms enabling the delivery of information, therapeutic support, and advice in a personalized and adaptive manner, informed by participants' ongoing inputs and interaction patterns. The intervention will be structured into 20 chatbot-deliver
Primary outcome measures
- Self-reported insomnia severity [Time frame: 6-month follow-up]
Secondary outcome measures (6)
- Health-related quality of life [Time frame: 3- and 6-month follow-ups]
- Sleep-related quality of life [Time frame: 3- and 6-month follow-ups]
- Depressive symptoms [Time frame: 3- and 6-month follow-ups]
- Anxiety symptoms [Time frame: 3- and 6-month follow-ups]
- Sleep effort [Time frame: 3- and 6-month follow-ups]
- Pre-sleep arousal [Time frame: 3- and 6-month follow-ups]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Hong Kong · 1 center
- School of Public Health, The University of Hong Kong, 18/F, Metro South Tower 1, 39 Wong C — Hong Kong
Identifiers
NCT: NCT07711769 · dCBT-I in University Students