Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

23 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Tsz Kiu Chan
  • Número de teléfono: +852 5506 4711
  • Correo electrónico: natctk1@hku.hk

Ubicaciones de estudio

  • 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
        • Contacto:
        • Investigador principal:
          • Shengzhi Zhao
        • Contacto:
          • Tsz Kiu Chan
          • Número de teléfono: +852 5506 4711
          • Correo electrónico: natctk1@hku.hk

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Grupo de intervención
Conductual: 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.
Conductual: 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
Conductual: 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
Comparador activo: Grupo de control
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Self-reported insomnia severity
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Health-related quality of life
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment rate
Periodo de tiempo: Baseline
Defined as the number of participants divided by the number of eligible university students.
Baseline
Retention rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

The University of Hong Kong

Investigadores

  • Investigador principal: Shengzhi Zhao, The University of Hong Kong

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

30 de septiembre de 2027

Finalización del estudio (Estimado)

31 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

13 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de julio de 2026

Publicado por primera vez (Actual)

17 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • dCBT-I in University Students

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir