NCT07711769

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

July 13, 2026

Last Update Submit

July 23, 2026

Conditions

Mental Health

Keywords

Cognitive Behavioral Therapy for Insomniainsomnialarge language modelchatbotuniversity student

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Health-related quality of life

    3- and 6-month follow-ups

  • Sleep-related quality of life

    3- and 6-month follow-ups

  • Depressive symptoms

    3- and 6-month follow-ups

  • Anxiety symptoms

    3- and 6-month follow-ups

  • Sleep effort

    3- and 6-month follow-ups

  • +1 more secondary outcomes

Other Outcomes (5)

  • Recruitment rate

    Baseline

  • Retention rate

    3- and 6-month follow-ups

  • Engagement rate of the interventions

    3- and 6-month follow-ups

  • +2 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: Brief sleep health adviceBehavioral: 2 weeks of chatbot-based daily sleep diaryBehavioral: 10 weeks chatbot-based IM support

Control group

ACTIVE COMPARATOR
Behavioral: Brief sleep health advice

Interventions

Brief sleep health adviceBEHAVIORAL

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.

Control groupIntervention group
10 weeks chatbot-based IM supportBEHAVIORAL

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

Intervention group
2 weeks of chatbot-based daily sleep diaryBEHAVIORAL

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

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Psychological Well-BeingSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Shengzhi Zhao

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengzhi Zhao

CONTACT

+852 6561 4500lubabezz@connect.hku.hk

Tsz Kiu Chan

CONTACT

+852 5506 4711natctk1@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding of the participants and treatment providers will not be possible because the behavior nature of the intervention, but the outcome assessors and statistical analysts will be blinded to group allocation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 17, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)