- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00621465
Critical Time Intervention in the Transition From Hospital to Community in People With Severe Mental Illness
CTI in the Transition From Hospital to Community
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Severe mental illness (SMI) encompasses a wide range of mental disorders and disabilities, but commonly includes disorders that involve symptoms of psychosis. Psychotic symptoms may involve hallucinations, a lost sense of reality, or other distressing symptoms. About 6% of people experiencing psychotic symptoms seek inpatient treatment at a psychiatric hospital. Hospital treatment for a person with SMI often focuses on rapid improvement of negative symptoms and promotion of the necessary skills to successfully return to the community after leaving the hospital. Despite preparation for community integration, the transition from hospital to community remains a difficult time for many people with SMIs, with those affected having an increased chance for suicide, homelessness, and relapse. Critical Time Intervention (CTI), a psychosocial treatment program that aims to restore skills for community living and to assist in seeking service and support in the community, may be more effective than usual care in preventing these adverse outcomes after hospital discharge. This study will compare the effectiveness of CTI versus usual services in preventing homelessness and other adverse outcomes after leaving a psychiatric hospital among people with SMI and psychosis.
Participation in this study will last 18 months. Potential participants will undergo an initial 15- to 30-minute interview that will include questions about current mental, physical, and living conditions; history of psychiatric services; and alcohol and drug use. Eligible participants will then undergo the first full interview, which will include a full review of medical records and will last between 2 and 3 hours. After this interview, participants will be assigned randomly to receive CTI or usual services. For participants assigned to CTI, a CTI specialist will visit participants in the hospital and in their homes and will stay in contact with participants for 9 months after hospital discharge. During visits with the CTI specialist, participants will receive training in community living skills and help finding service and support in the community. Participants assigned to usual services will receive the usual care and community services offered to people recently leaving a psychiatric hospital.
After leaving the hospital, participants in both groups will be asked to participate in 15 follow-up interviews, which will include repeat questions from the 2 initial interviews. Interviews will be conducted once every 6 weeks until 18 months after hospital discharge and will last between 60 and 90 minutes.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Orangeburg, New York, Estados Unidos, 10962
- Rockland Psychiatric Center
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of psychosis
- Homelessness during the 18 months before study entry
- English speaking
Plan de estudios
¿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 |
---|---|
Comparador activo: 1
Participants will receive standard aftercare and community care services.
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Usual care will include the standard aftercare and community care services.
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Experimental: 2
Participants will receive usual care and the Critical Time Intervention.
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Usual care will include the standard aftercare and community care services.
CTI is designed specifically to enhance the continuity and focus of care during the transition from psychiatric hospital to community care.
CTI does not replace community treatment and support, but instead is meant to complement available services.
CTI will provide training in community living skills and in team-managed transfer of caregiving from hospitals to services and supports in the community.
Participants will receive CTI for 9 months after hospital discharge.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number of adverse outcomes after hospital discharge, particularly homelessness
Periodo de tiempo: Measured over 18 months
|
Measured over 18 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Daniel Herman, DSW, NYS Psychiatric Institute
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01 MH059716,#4640R
- R01MH059716 (Subvención/contrato del NIH de EE. UU.)
- DSIR SE-MS
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. .
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