- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00042198
Treatment of Depression After Coronary Bypass Surgery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Depression is a very common problem for people who have had CABG surgery, and recent studies have shown that it may increase the risk of additional medical problems and death during the first few years after surgery. Cognitive behavior therapy (CBT) has been shown to be efficacious for depression in otherwise healthy individuals, and supportive stress management (SSM) interventions have also been shown to improve depressive symptoms. These therapies have not, however, been tested for depression in individuals who have undergone CABG surgery.
Participants will be screened for depression within 1 year after CABG surgery. Those who have depression will return for additional testing 1 week later. Eligible participants will be randomized to receive CBT, SSM, or usual care (UC), with no restrictions on nonstudy antidepressants, for 12 weeks. Patients will be monitored for worsening depression referred for additional care if needed. Depression, anxiety, and health-related quality of life will be assessed at baseline, 12 weeks after randomization, and 6 months after surgery (2 months after termination of CBT or SSM).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Missouri
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St. Louis, Missouri, Estados Unidos, 63108
- Washington University School of Medicine
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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:
- Coronary Artery Bypass Graft (CABG) surgery (alone or combined with valvular or carotid surgery) within past 12 months
- Meets DSM-IV criteria for major or minor depressive episode
Exclusion Criteria:
- Severe cognitive impairment
- Severe psychiatric comorbidity (e.g., alcoholism or schizophrenia)
- Severely debilitating or life-threatening illness other than coronary disease
Plan de estudios
¿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 |
---|---|
Experimental: 1
Cognitive Behavior Therapy.
The treatment modality was individual, face-to-face therapy with an experienced cognitive therapist.
Treatment consisted of up to 12 weekly, hour-long sessions.
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Up to 12 weekly, individual, hour-long sessions
|
Comparador activo: 2
Supportive Stress Management.
The treatment modality was individual, face-to-face therapy with an experienced psychotherapist.
Treatment consisted of up to 12 weekly, hour-long sessions.
|
Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors
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Sin intervención: 3
Usual Care, minimally enhanced.
Participants in all three arms were given information about depression.
There were no restrictions in any of the arms on usual care for depression, heart disease, or any other conditions, except that concurrent participation in nonstudy psychotherapy was not allowed.
Participants were allowed to continue or start on nonstudy antidepressants during the study, as prescribed by the participant's personal physician.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Hamilton Rating Scale for Depression (HAM-D-17)
Periodo de tiempo: 12 weeks post-randomization
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The HAM-D-17 is an observer-rated measure of the severity of depression.
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12 weeks post-randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Beck Depression Inventory
Periodo de tiempo: 12 weeks post-randomization
|
The BDI is a self-report measure of the severity of depression.
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12 weeks post-randomization
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Beck Anxiety Inventory
Periodo de tiempo: 12 weeks post-randomization
|
The BAI is a self-report measure of the severity of anxiety symptoms.
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12 weeks post-randomization
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Beck Hopelessness Scale
Periodo de tiempo: 12 weeks post-randomization
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The BHS is a self-report measure of hopelessness.
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12 weeks post-randomization
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Perceived Stress Scale
Periodo de tiempo: 12 weeks post-randomization
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The PSS is a self-report measure of perceived stress
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12 weeks post-randomization
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SF-36
Periodo de tiempo: 12 weeks post-randomization
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The Medical Outcomes Study SF-36 is a measure of health-related quality of life.
The Physical and Mental factor scores will be reported.
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12 weeks post-randomization
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kenneth E Freedland, Ph.D., Washington University School of Medicine
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
- R01MH060735 (Subvención/contrato del NIH de EE. UU.)
- DSIR AT-AS
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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