Morning Activation to Improve Mood After Stroke
17 de julio de 2026 actualizado por: Prof. LAU Chun Lun Stephen, The Hong Kong Polytechnic University
This pilot randomized controlled trial will evaluate the feasibility and preliminary effects of a six-week behavioral intervention designed to improve mood and daily functioning in adults who have experienced a stroke and report depressive symptoms and difficulty becoming engaged in activities after waking.
Participants will be randomly assigned to either the behavioral intervention or a health education program. Assessments will be completed before and immediately after the six-week program and will include questionnaires and seven-day monitoring of sleep, activity, and mood. The study will also examine feasibility indices such as participant retention, intervention attendance, acceptability, and preliminary changes in mood.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
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: Stephen Lau
- Número de teléfono: +852 2766 4283
- Correo electrónico: chun-lun-stephen.lau@polyu.edu.hk
Ubicaciones de estudio
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Hong Kong, Hong Kong
- Reclutamiento
- The Hong Kong Polytechnic University
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Contacto:
- Stephen Lau
- Número de teléfono: +852 2766 4283
- Correo electrónico: chun-lun-stephen.lau@polyu.edu.hk
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Investigador principal:
- Stephen Lau, PhD
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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:
- Age 18 years or older.
- History of stroke at least 6 months before enrollment.
- Patient Health Questionnaire-9 score of 10 or higher.
- Difficulty getting started or engaging in activities in the morning.
- Able to provide informed consent.
Exclusion Criteria:
- Conditions that would interfere with study participation.
- Neurological condition other than stroke.
- Currently receiving psychological therapy for depression.
- Significant cognitive impairment or dementia.
- Current or past diagnosis of psychosis, bipolar disorder, or mania.
- Hospitalization that would interfere with study participation.
- Acute or significant suicidal ideation
- Alcohol or substance use problems within the past month.
- Use of antidepressant or anti-anxiety medication unless the dosage has been stable for at least 4 weeks and no changes are planned during the study.
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: Morning Activation Program
Participants will receive a six-week individualized behavioral program delivered in weekly sessions of approximately 60 minutes.
The program is designed to support engagement in daily activities after waking, establish consistent daily routines, and improve mood and functioning after stroke.
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A six-week individualized behavioral program delivered in weekly sessions of approximately 60 minutes.
The program is designed to support engagement in daily activities after waking, establish consistent daily routines, and improve mood and functioning after stroke.
Sessions will be tailored to participants' needs and abilities.
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Comparador activo: Health Education Program
Participants will receive a six-week health education program delivered in weekly sessions of approximately 60 minutes.
The program will provide general information relevant to health and recovery after stroke and will be matched to the experimental program in session frequency and duration.
It will not include the individualized behavioral strategies provided in the experimental arm.
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A six-week health education program delivered in weekly sessions of approximately 60 minutes.
The program will provide general information relevant to health and recovery after stroke and will be matched to the experimental program in session frequency and duration.
It will not include the individualized behavioral strategies provided in the experimental arm.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recruitment Rate
Periodo de tiempo: From the start of recruitment until enrollment of the final participant.
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Number of participants enrolled divided by the number of months of active recruitment.
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From the start of recruitment until enrollment of the final participant.
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Retention Rate
Periodo de tiempo: Immediately after completion of the 6-week intervention
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Number of randomized participants who complete the immediate post-intervention assessment divided by the total number randomized, expressed as a percentage.
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Immediately after completion of the 6-week intervention
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Intervention Attendance
Periodo de tiempo: Throughout the 6-week intervention period
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Number and percentage of scheduled intervention or health education sessions attended by each participant during the 6-week program.
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Throughout the 6-week intervention period
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Intervention Acceptability
Periodo de tiempo: Immediately after completion of the 6-week intervention
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Acceptability of the assigned program assessed using the 4-item Acceptability of Intervention Measure.
Each item is rated from 1 to 5, producing a total score ranging from 4 to 20.
Higher scores indicate greater intervention acceptability.
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Immediately after completion of the 6-week intervention
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Participants Experiencing Adverse Events
Periodo de tiempo: From enrollment through completion of the immediate post-intervention assessment.
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Number of adverse events considered related or possibly related to study participation.
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From enrollment through completion of the immediate post-intervention assessment.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Depressive Symptoms
Periodo de tiempo: Baseline and immediately after completion of the 6-week intervention
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Depressive symptom severity assessed using the 9-item Patient Health Questionnaire-9.
Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
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Baseline and immediately after completion of the 6-week 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 (Actual)
15 de mayo de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
17 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2026
Publicado por primera vez (Actual)
22 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HSEARS20260321001
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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