Preventing Chronic Depression and PTSD in Stroke Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Family Caregivers
15 de agosto de 2018 actualizado por: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
Preventing Chronic Depression and PTSD in Patients With Stroke Admitted to the Neuroscience ICU and Their Family Caregivers
The current study has the following objectives:
- To determine additional stroke patient (SP) and stroke caregiver (SC) factors including their perceptions of the stroke experience, hospitalization, and how they cope with its challenges; identify additional appropriate points to intervene (maladaptive coping styles, unrealistic expectations, inappropriate prioritization, misinformation about illness, and self care), and assess SP and SC preferences for the structure, mode of delivery (including potential for phone, video or a combination of these) and timing of an intervention.
- To develop, [using the preliminary data and information from aim 1], and test the feasibility and acceptability (primary outcomes) of a skills-based intervention for preventing chronic depression, anxiety, PTSD and decreased QoL in dyads at risk.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
15
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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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Eligible dyads (stroke patients and stroke caregivers) must meet the following inclusion criteria:
- Age 18 or older
- English fluency and literacy
- Hospitalized with an acute stroke (hemorrhagic and ischemic) within the past 2 weeks (patient) OR primary stroke caregiver of a stroke patient currently admitted with an acute stroke
- Stroke patient or stroke caregiver screens in for depression and/or PTSD
One or more of the following exclusion criteria will render a stroke patient (only) ineligible:
- Stroke patients who cannot participate due to the severity of stroke, cognitive impairment and/or aphasia, and are anticipated to not be able to participate due to permanent impairment as judged by the medical team.
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Psychosocial Skills-Based Intervention
Based on information from Phase I (semi-structured interviews), the investigators will develop a detailed psychosocial intervention manual.
The intervention will be tailored consistent with American Heart Association (AHA) recommendations for stroke skills based interventions and will include 2 general and 4 specific modules (selected from 7 available).
Generally, in the intervention, stroke patients and stroke caregivers will learn skills to cope and manage stroke-related stressors.
It is anticipated that the intervention will have 6 sessions with 2 general sessions delivered within the NICU face to face and 4 tailored specific sessions to be delivered via live video using Vidyo.
Participants in the intervention group will also receive treatment as usual.
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Subjects will attend group skills-based sessions once weekly (either in-person or via Vidyo) for 6 weeks and learn skills to cope and manage stroke-related stressors.
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Sin intervención: Minimally Enhanced Usual Care (MEUC)
Those in the MEUC will continue with their current care.
This may include meeting with nurses, physical therapist, medical doctors, and other members of the stroke patient's medical team.
Treatment as usual may also involve administration of Selective Serotonin Reuptake Inhibitors (SSRIs) to those patients with motor problems.
They will also received a pamphlet with educational information on stroke and recovery
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of the Intervention
Periodo de tiempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Demonstration of feasibility will be assessed by the number of individuals who drop out of the study prior to completing the post- intervention assessment and the rate of missed sessions.
If drop-out rate or missed-session rate exceeds 25%, revisions to the intervention may be needed.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Client Satisfaction Questionnaire (CSQ-8)
Periodo de tiempo: Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures how satisfied the participant is with the intervention.
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Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Measure of Current Status (MOCS-A)
Periodo de tiempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Cognitive and Affective Mindfulness Scale (CAMS)
Periodo de tiempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures the degree to which individuals experience their thoughts and feelings.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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World Health Organization QOL Questionnaire (WHOQOL-BREF)
Periodo de tiempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Modified Rankin Scale (mRS)
Periodo de tiempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures the patient's prior stroke status and stroke severity.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures symptoms of anxiety and depression.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Posttraumatic Stress (PCL-S)
Periodo de tiempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures symptoms of posttraumatic stress disorder
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Current psychotropic meds and comorbid medical conditions,
Periodo de tiempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Study staff will collect information on patient's medical history and current medications to measure their mental health throughout the study.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Barthel Index
Periodo de tiempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures the patient's prior stroke status and stroke severity.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Edad, sexo, raza, origen étnico, estado civil, nivel educativo y estado laboral de los pacientes/cuidadores en la UCI
Periodo de tiempo: Línea de base (semana 0)
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Este cuestionario pide a los pacientes/cuidadores de la UCI que informen su edad, sexo, raza, origen étnico, estado civil, nivel educativo más alto y situación laboral principal durante los últimos 12 meses.
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Línea de base (semana 0)
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Cuestionario de Credibilidad
Periodo de tiempo: Línea de base (semana 0)
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Mide cuánto cree el participante que funcionará la intervención.
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Línea de base (semana 0)
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Prior Mental Health Questionnaire
Periodo de tiempo: Baseline (week 0)
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This questionnaire asks ICU patients/caregivers to report any previous or current mental health conditions that they have been diagnosed with in the past.
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Baseline (week 0)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
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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)
1 de julio de 2016
Finalización primaria (Actual)
1 de junio de 2018
Finalización del estudio (Actual)
1 de agosto de 2018
Fechas de registro del estudio
Enviado por primera vez
2 de junio de 2016
Primero enviado que cumplió con los criterios de control de calidad
7 de junio de 2016
Publicado por primera vez (Estimar)
13 de junio de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de agosto de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
15 de agosto de 2018
Última verificación
1 de agosto de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2016P001190
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Indeciso
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. .