- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00270959
Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury (TSOS II)
Early Combined Intervention After Traumatic Injury
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Approximately 2.5 million people in the U.S. are hospitalized each year having sustained injuries during a traumatic event. Injured trauma survivors are at high risk for developing post-traumatic stress disorder (PTSD) and other related conditions. In addition, many of these people experience several physical, financial, social, legal, and medical problems over the course of the year following the trauma. Effective interventions to prevent or remedy these issues have yet to be developed for individuals who undergo inpatient surgery following a traumatic injury and who then continue with outpatient treatment and community rehabilitation. This study will evaluate the effectiveness of patient-centered collaborative care that combines behavioral therapy and drug therapy as compared to usual care in reducing symptoms of PTSD and substance use. The study will also assess the intervention's effectiveness in increasing participants' general functioning and satisfaction with their care post-injury.
Participants in this open label study will be randomly assigned to receive either the standard care provided to injured trauma survivors or a combination of behavioral therapy and drug therapy. Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine; sertraline; paroxetine; buspirone; propranolol; trazodone; and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Behavioral therapy will also be administered on the basis of the participants' individual needs and may continue for up to 12 months. Participants will also take part in motivational interviews, the first of which will be conducted upon study entry in the hospital ward. Subsequent interviews will be conducted over the phone at Months 1, 3, 6, 9, and 12. Participants will be required to report to the study site only for the initial baseline visit. Outcome measures will include PTSD severity ratings, frequency of substance use, and general functioning reports.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Harborview Medical 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:
- English-speaking
- Admitted to Harborview Medical Center with injuries sufficiently severe to require inpatient admission
- Experienced a traumatic injury
- Exhibits symptoms of PTSD while in the hospital ward
Exclusion Criteria:
- History of head, spinal, or other injury that may prevent participation in the ward interview
- Requires immediate intervention due to conditions such as self-inflicted injury, active psychosis, or active mania
- Currently incarcerated
- Likely to face criminal charges
- Lives more than 50-100 miles from Harborview Medical Center
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1
Stepped collaborative care (combination of behavioral therapy and drug therapy)
|
Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation.
Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.
Otros nombres:
Motivational interviewing is designed to address alcohol and drug use.
Otros nombres:
Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines.
Participants may begin receiving medication immediately or anytime within the 12 months post-injury.
Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.
|
Comparador activo: 2
Standard care provided to injured trauma survivors
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Standard care control includes the usual treatment for injured trauma survivors.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
PTSD ratings
Periodo de tiempo: Measured at Year 1
|
Measured at Year 1
|
Substance use
Periodo de tiempo: Measured at Year 1
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Measured at Year 1
|
General functioning reports
Periodo de tiempo: Measured at Year 1
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Measured at Year 1
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Increased satisfaction with global care
Periodo de tiempo: Measured at Year 1
|
Measured at Year 1
|
Injury relapse
Periodo de tiempo: Measured at Year 5
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Measured at Year 5
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Work, disability, and legal outcomes
Periodo de tiempo: Measured at Year 1
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Measured at Year 1
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Douglas F. Zatzick, MD, University of Washington
Publicaciones y enlaces útiles
Publicaciones Generales
- Zatzick D, Roy-Byrne P, Russo J, Rivara F, Droesch R, Wagner A, Dunn C, Jurkovich G, Uehara E, Katon W. A randomized effectiveness trial of stepped collaborative care for acutely injured trauma survivors. Arch Gen Psychiatry. 2004 May;61(5):498-506. doi: 10.1001/archpsyc.61.5.498.
- Zatzick DF, Rivara FP, Nathens AB, Jurkovich GJ, Wang J, Fan MY, Russo J, Salkever DS, Mackenzie EJ. A nationwide US study of post-traumatic stress after hospitalization for physical injury. Psychol Med. 2007 Oct;37(10):1469-80. doi: 10.1017/S0033291707000943. Epub 2007 Jun 11.
- Zatzick DF, Russo J, Pitman RK, Rivara F, Jurkovich G, Roy-Byrne P. Reevaluating the association between emergency department heart rate and the development of posttraumatic stress disorder: A public health approach. Biol Psychiatry. 2005 Jan 1;57(1):91-5. doi: 10.1016/j.biopsych.2004.10.005.
- Zatzick D, Jurkovich G, Rivara FP, Russo J, Wagner A, Wang J, Dunn C, Lord SP, Petrie M, O'connor SS, Katon W. A randomized stepped care intervention trial targeting posttraumatic stress disorder for surgically hospitalized injury survivors. Ann Surg. 2013 Mar;257(3):390-9. doi: 10.1097/SLA.0b013e31826bc313.
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 (Actual)
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
- 24069
- R01MH073613 (Subvención/contrato del NIH de EE. UU.)
- DSIR 82-SECE
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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