- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07714681
Developing and Testing a Brief Mindfulness Just-in-time Adaptive Intervention for Reducing Stress of Dementia Caregivers
14 de julio de 2026 actualizado por: Chou Kee Lee, Education University of Hong Kong
- To determine an effective decision rule for delivering brief mindfulness prompts as a function of caregivers' real-time stress state, including whether prompt delivery affects subsequent stress and affect and whether this effect varies by stress state at the decision point.
- To determine an effective JITAI decision rule to deliver a brief mindfulness intervention depending the current state of stress of caregivers and to examine if the adaptive model of machine learning algorithm generate higher receptivity of the brief intervention than the static and control model at the end of the four weeks.
- To evaluate the feasibility, acceptability, and preliminary effects of the brief mindfulness just-in-time adaptive intervention on perceived stress and related caregiver outcomes.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
195
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.
Ubicaciones de estudio
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Hong Kong, Hong Kong
- The Education University of Hong Kong
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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
Sí
Descripción
Inclusion Criteria:
- family dementia caregivers aged 18 above
- family caregiver of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community
- having been providing care for ADLs and IADLs for at least 20 hours per week for at least one year prior to recruitment
- have a smartphone
- have moderate to high stress
Exclusion Criteria:
- Having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment
- Having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers participation or adherence (e.g. acute psychosis).
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Grupo 2
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In the second phase, the receptivity of the brief mindfulness intervention will be examined within a just-in-time adaptive intervention (JITAI) framework, comprising distal outcomes, a proximal outcome (engagement with the brief intervention), decision points, intervention options (which notification-delivery model is applied), a tailoring variable (predicted receptivity), and decision rules.
In the first four days, as in the first phase, participants will be interviewed with a structured questionnaire and will receive a four-day psycho-education intervention.
Over the subsequent 14-day micro-randomized trial (Day 5 to Day 18), notification-delivery models will be randomized at scheduled daily decision points.
From Day 5 to Day 11, prompts will be delivered by either a random or a static machine-learning model with equal probability; from Day 12 to Day 18, prompts will be delivered by a random, static, or adaptive machine-learning model with equal probability, with the adaptive model u
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Experimental: Grupo 1
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In the first phase of the study, participants will be interviewed by a research assistant over the phone with a structured questionnaire on the first day of the study period.
They will then receive a four-day psycho-education intervention, during which the study application will be installed on their smartphone.
At the end of the fourth day, participants will be asked to use the app for the following 16 days of the micro-randomized trial (MRT).
In the 16-day MRT (Day 5 to Day 20), zero to six ecological momentary assessments (EMAs), separated by at least 30 minutes, will be delivered each day (from one hour after self-reported wake time to one hour before self-reported sleep time) to classify whether the participant is probably-stressed or probably-not-stressed using a single stress item.
Immediately following each EMA, participants will be randomized to receive a brief mindfulness intervention prompt or no prompt, with randomization occurring only if no brief mindfulness intervention
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perceived Stress
Periodo de tiempo: baseline and immediately after intervention
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14-item perceived stress scale.
Items are rated on a 5-point Likert scale, ranging from 0-56,with higher scores indicating greater perceived stress.
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baseline and immediately after intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depressive Symptoms
Periodo de tiempo: baseline and immediately after intervention
|
Patient health questionnaire 9, items are rated on a 4-point scale, ranging from 0 to 27, with higher scores reflecting greater depression severity.
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baseline and immediately after intervention
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caregiving burden
Periodo de tiempo: baseline and immediately after intervention
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12-item Zarit Burden Interview, items are rated on a 5-point scale, ranging from 0-48, with higher scores denoting greater burden.
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baseline and immediately after intervention
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Positive Aspect of Caregiving
Periodo de tiempo: baseline and immediately after intervention
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Positive Aspects of Caregiving Scale, items are rated on a 5-point Likert scale, ranging from 9-45, with higher scores indicating a more positive appraisal
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baseline and immediately after intervention
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sleep quality
Periodo de tiempo: baseline and immediately after intervention
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Pittsburgh Sleep Quality Index, score ranging from 0-21, with higher scores indicate poorer sleep quality.
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baseline and immediately after intervention
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quality of life
Periodo de tiempo: baseline and immediately after intervention
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EuroQoL 5-Dimension 5-Level measures across 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), score ranging from 0-100, higher scores reflect better health-related quality of life.
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baseline and immediately after intervention
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Mindfulness
Periodo de tiempo: baseline and immediately after intervention
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15-item Mindful Attention Awareness Scale, items are rated on a 6-point scale, score ranging from 1-6, with higher scores indicating greater dispositional mindfulness.
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baseline and immediately after intervention
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prompt-Specific Questions
Periodo de tiempo: during and immediately after intervention
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app backend records of post-prompt engagement with the brief intervention, including just-in-time response (engagement within the just-in-time window) and response delay; and single-item ecological momentary assessment ratings of stress, positive mood, and negative mood administered immediately following each completed intervention
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during and immediately after intervention
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feasibility and acceptability rate of the app
Periodo de tiempo: immediately after intervention
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immediately after intervention
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mindfulness intervention specific questions
Periodo de tiempo: immediately after intervention
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immediately after intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kee Lee Chou, PhD, The Education 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 (Actual)
18 de noviembre de 2024
Finalización primaria (Actual)
31 de diciembre de 2025
Finalización del estudio (Actual)
31 de diciembre de 2025
Fechas de registro del estudio
Enviado por primera vez
8 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de julio de 2026
Publicado por primera vez (Actual)
20 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2021-2022-0276
- 20210051 (Otro número de subvención/financiamiento: Health and Medical Research Fund)
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. .