Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems
23. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Shengzhi Zhao
- Telefonnummer: +852 6561 4500
- E-post: lubabezz@connect.hku.hk
Studer Kontakt Backup
- Navn: Tsz Kiu Chan
- Telefonnummer: +852 5506 4711
- E-post: natctk1@hku.hk
Studiesteder
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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
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Ta kontakt med:
- Shengzhi Zhao
- Telefonnummer: +852 6561 4500
- E-post: lubabezz@connect.hku.hk
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Hovedetterforsker:
- Shengzhi Zhao
-
Ta kontakt med:
- Tsz Kiu Chan
- Telefonnummer: +852 5506 4711
- E-post: natctk1@hku.hk
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Intervensjonsgruppe
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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.
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
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
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Aktiv komparator: Kontrollgruppe
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Self-reported insomnia severity
Tidsramme: 6-month follow-up
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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.
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6-month follow-up
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Health-related quality of life
Tidsramme: 3- and 6-month follow-ups
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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.
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3- and 6-month follow-ups
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Sleep-related quality of life
Tidsramme: 3- and 6-month follow-ups
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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.
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3- and 6-month follow-ups
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Depressive symptoms
Tidsramme: 3- and 6-month follow-ups
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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.
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3- and 6-month follow-ups
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Anxiety symptoms
Tidsramme: 3- and 6-month follow-ups
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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.
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3- and 6-month follow-ups
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Sleep effort
Tidsramme: 3- and 6-month follow-ups
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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.
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3- and 6-month follow-ups
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Pre-sleep arousal
Tidsramme: 3- and 6-month follow-ups
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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.
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3- and 6-month follow-ups
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Recruitment rate
Tidsramme: Baseline
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Defined as the number of participants divided by the number of eligible university students.
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Baseline
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Retention rate
Tidsramme: 3- and 6-month follow-ups
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Defined as the number of participants who completed the follow-up divided by the number of participants.
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3- and 6-month follow-ups
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Engagement rate of the interventions
Tidsramme: 3- and 6-month follow-ups
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Engagement rate will be determined by Instant message (IM) log.
At least 2 times response will be considered as engaged.
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3- and 6-month follow-ups
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Usability for the development of a full-scale trial
Tidsramme: 3- and 6-month follow-ups
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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.
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3- and 6-month follow-ups
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Usability of the chatbot
Tidsramme: 3- and 6-month follow-ups
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The usability of the chatbot (Cronbach's alpha: 0.90) is measured by the validated 15-item Bot Usability Scale (BUS).
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3- and 6-month follow-ups
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Shengzhi Zhao, The University of Hong Kong
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
30. september 2027
Studiet fullført (Antatt)
31. oktober 2027
Datoer for studieregistrering
Først innsendt
13. juli 2026
Først innsendt som oppfylte QC-kriteriene
13. juli 2026
Først lagt ut (Faktiske)
17. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- dCBT-I in University Students
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