Brief Behavioral Intervention for Insomnia Among Adults With Sleep Disturbances
17 de mayo de 2026 actualizado por: National Taiwan University Hospital
Effectiveness of a Nurse-led Brief Behavioral Intervention for Insomnia With Health Education Chatbot Assistance Among Community-dwelling Adults: a Randomized Controlled Trial
The goal of this interventional study is to develop a in person nurse-led Brief Behavioral Treatment for Insomnia (BBT-I) intervention integrated with a chatbot and evaluate its effects on sleep disturbance, anxiety, depression, and fatigue among community-dwelling adults, as well as user acceptance and satisfaction with the chatbot-assisted intervention.
Participants who meet the inclusion criteria will be randomly assigned to either an intervention group receiving BBT-I combined with a chatbot or a self-monitoring control group.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
80
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
- Nombre: Fen He Lin, Ph.D. candidate
- Número de teléfono: +886 955 092 848
- Correo electrónico: smallbox0955092848@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Jung Chen Chang, Ph.D.
- Número de teléfono: 288905 886-2-23123456
- Correo electrónico: jungchenchang@ntu.edu.tw
Ubicaciones de estudio
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Taipei, Taiwán
- Public classrooms, meeting rooms, or community activity centers
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Contacto:
- Fen He Lin, Ph.D. candidate
- Número de teléfono: +886 955 092 848
- Correo electrónico: smallbox0955092848@gmail.com
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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:
- Adults aged 18 or older
- Self-reported have sleep disturbances, such as: difficulty falling asleep, difficulty maintaining sleep, waking up too early and being unable to fall asleep
Exclusion Criteria:
- Individuals with cognitive impairment who are unable to communicate in Mandarin or Taiwanese
- Individuals lack the ability to use smartphones to join the chatbot group
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Receiving BBT-I intervention combined with a chatbot support
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An in-person, nurse-led Brief Behavioral Treatment for Insomnia (BBT-I) intervention, supplemented by an chatbot that provides educational content and remote, two-way interactive support.
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Sin intervención: Self-monitoring control group
Participants are only required to self-monitor their sleep patterns and join a chatbot group for contact.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sleep and health diary
Periodo de tiempo: Daily self-recording during one month intervention period
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Daily self-recording of sleep behaviors during the intervention.
Such as time in/out of bed, napping, and subjective sleep quality along with lifestyle factors like screen time, diet, and exercise, helps researchers understand subjects' actual sleep patterns and health behaviors.
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Daily self-recording during one month intervention period
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Insomnia Severity Index
Periodo de tiempo: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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The Insomnia Severity Scale (ISI) is a 7-item self-report scale for insomnia symptoms.
Participants self-report their difficulty falling asleep, difficulty maintaining sleep, early awakening, and the severity of these symptoms' impact on daily life.
Each item on the ISI is scored on a 5-point Likert scale (0-4 points), with the total score ranging from 0 to 28 points.
Higher score indicates more severe insomnia.
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Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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Pittsburgh Sleep Quality Index
Periodo de tiempo: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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Pittsburgh Sleep Quality Scale (PSQI) was utilized to assess the level of sleep disturbances for adults.
The PSQI is a 19-item self-administered questionnaire scored on a Likert scale from 0 to 3. Higher score indicates greater sleep disturbances.
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Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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Patient Health Questionnaire 9-item
Periodo de tiempo: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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The Patient Health Questionnaire 9-item (PHQ-9) scale contains 7 items to assess the level of depression over the past two weeks.
Each item is rated on a 4-point Likert scale, ranging from 0 (never) to 3 (almost every day).
The scale score range is 0 to 27.
Higher score indicates more severe depression level.
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Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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Generalized Anxiety Disorder 7 Item
Periodo de tiempo: Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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Generalized Anxiety Disorder 7 Item (GAD-7) consists of 7 questions asking about anxiety symptoms or feelings over the past two weeks.
Each question is scored on a 4-point Likert scale, ranging from 0 (never) to 3 (almost every day), with a score range of 0 to 21.
Higher score indicates greater level of anxiety.
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Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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User acceptance and satisfaction with the chatbot-assisted intervention
Periodo de tiempo: After four weeks intervention
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Based on the six dimensions of the Healthcare Information System (HIS) success model proposed by DeLone and McLean (2003), a questionnaire was designed to assess the intervention group's satisfaction with and acceptance of the education chatbot.
This self-administered tool utilized a 5-point Likert scale (ranging from 1 to 5), where higher scores indicate greater acceptance and satisfaction.
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After four weeks intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 junio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de enero de 2027
Fechas de registro del estudio
Enviado por primera vez
7 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de mayo de 2026
Publicado por primera vez (Actual)
22 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202603048RINE
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
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