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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: Brief sleep health advice; Behavioral: 2 weeks of chatbot-based daily sleep diary; Behavioral: 10 weeks chatbot-based IM support

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shengzhi Zhao; Phone Number: +852 6561 4500; Email: lubabezz@connect.hku.hk
• Study Contact Backup: Name: Tsz Kiu Chan; Phone Number: +852 5506 4711; Email: natctk1@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • School of Public Health, The University of Hong Kong, 18/F, Metro South Tower 1, 39 Wong Chuk Hang Road, Wong Chuk Hang, Hong Kong
    • Contact: Shengzhi Zhao; Phone Number: +852 6561 4500; Email: lubabezz@connect.hku.hk
    • Principal Investigator: Shengzhi Zhao
    • Contact: Tsz Kiu Chan; Phone Number: +852 5506 4711; Email: natctk1@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	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 tailored and personalized feedback, supporting individualized sleep recommendations and behavioral adjustments. At the initiation of the intervention, participants will also complete a brief baseline questionnaire to establish personalized treatment goals related to sleep improvement. Throughout the intervention period, participants will have continuous access to chatbot-delivered support, including adaptive guidance based on diary inputs, reinforcement of recommended sleep strategies, and progress; 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-delivered instant messaging (2 pieces per week). The therapeutic content is adapted from established CBT-I manuals and led by research nurse, incorporating evidence-based behavioral, cognitive, and educational components. Behavioral strategies include sleep restriction, stimulus control, and relaxation techniques. Cognitive components comprise paradoxical intention, cognitive restructuring, mindfulness-based techniques, positive imagery, and strategies for "putting the day to rest." Educational compone
Active Comparator: Control group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported insomnia severity	Assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item self-report instrument that evaluates both nocturnal and daytime symptoms of insomnia, with total scores ranging from 0 to 28, higher scores indicate greater insomnia severity.	6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	Assessed using 36-Item Short Form Health Survey [SF-36]. The SF-36 is a 36-item self-reported instrument that measures both Physical Component Scores and Mental Component Scores, with scores ranging from 0 to 100; higher scores indicate better health-related quality of life.	3- and 6-month follow-ups
Sleep-related quality of life	Assessed using Glasgow Sleep Impact Index [GSII]. The GSII is a 7-item self-report instrument that evaluates the sleep-related quality of life, with total scores ranging from 0 to 28, higher scores indicate lower level of sleep-related quality of life.	3- and 6-month follow-ups
Depressive symptoms	Assessed using Patient Health Questionnaire-9 [PHQ-9]. The PHQ-9 is a 9-item self-report instrument that evaluates frequency and severity of depressive symptoms, with total scores ranging from 0 to 27, higher scores indicate higher level of depression.	3- and 6-month follow-ups
Anxiety symptoms	Assessed using Generalized Anxiety Disorder-7 [GAD-7]. The GAD-7 is a 7-item self-report instrument that evaluates the frequency and severity of anxious symptoms, with total scores ranging from 0 to 21, higher scores indicate higher level of anxiety.	3- and 6-month follow-ups
Sleep effort	Assessed using Glasgow Sleep Effort Scale [GSES]. The GSES is a 7-item self-reported instrument, with scores ranging from 0 to 14, higher scores indicate greater sleep effort.	3- and 6-month follow-ups
Pre-sleep arousal	Assessed using Pre-Sleep Arousal Scale [PSAS]. The PSAS is a 16-item self-reported instrument consists of two subscales (cognitive arousal and somatic arousal), with scores ranging from 8 to 40 on each subscale, higher scores indicate greater pre-sleep arousal.	3- and 6-month follow-ups

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Defined as the number of participants divided by the number of eligible university students.	Baseline
Retention rate	Defined as the number of participants who completed the follow-up divided by the number of participants.	3- and 6-month follow-ups
Engagement rate of the interventions	Engagement rate will be determined by Instant message (IM) log. At least 2 times response will be considered as engaged.	3- and 6-month follow-ups
Usability for the development of a full-scale trial	We will use the 10-item System Usability Scale (SUS) to assess perceived effectiveness, efficiency, and satisfaction of the intervention. The score of SUS ranges from 0 to 100 and 68 is the threshold to determine the usability for the development of a full-scale trial.	3- and 6-month follow-ups
Usability of the chatbot	The usability of the chatbot (Cronbach's alpha: 0.90) is measured by the validated 15-item Bot Usability Scale (BUS).	3- and 6-month follow-ups

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Shengzhi Zhao, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: insomnia; chatbot; Cognitive Behavioral Therapy for Insomnia; university student; large language model
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Personal Satisfaction; Sleep Initiation and Maintenance Disorders; Psychological Well-Being
• Other Study ID Numbers: dCBT-I in University Students

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No