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

13. juli 2026 opdateret af: Shengzhi Zhao, The University of Hong Kong

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Tsz Kiu Chan
  • Telefonnummer: +852 5506 4711
  • E-mail: natctk1@hku.hk

Studiesteder

  • 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
        • Kontakt:
        • Ledende efterforsker:
          • Shengzhi Zhao
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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, current suicidal ideation with intent or a suicide attempt within the past 2 months, current receipt of psychological or behavioral treatment for insomnia from a health professional, or participation in an online or digital insomnia treatment programme at the time of enrolment will be excluded.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Interventionsgruppe
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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
Adfærdsmæssigt: 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
Aktiv komparator: Kontrolgruppe
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Self-reported insomnia severity
Tidsramme: 6-month follow-up
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health-related quality of life
Tidsramme: 3- and 6-month follow-ups
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
Tidsramme: 3- and 6-month follow-ups
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
Tidsramme: 3- and 6-month follow-ups
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
Tidsramme: 3- and 6-month follow-ups
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
Tidsramme: 3- and 6-month follow-ups
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
Tidsramme: 3- and 6-month follow-ups
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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment rate
Tidsramme: Baseline
Defined as the number of participants divided by the number of eligible university students.
Baseline
Retention rate
Tidsramme: 3- and 6-month follow-ups
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
Tidsramme: 3- and 6-month follow-ups
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
Tidsramme: 3- and 6-month follow-ups
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
Tidsramme: 3- and 6-month follow-ups
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Hong Kong

Efterforskere

  • Ledende efterforsker: Shengzhi Zhao, The University of Hong Kong

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

31. oktober 2027

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • dCBT-I in University Students

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