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Treatment of Post-TBI Depression

20 de septiembre de 2013 actualizado por: Icahn School of Medicine at Mount Sinai

Treatment of Post-TBI Depression - A Randomized Clinical Trial

Randomized clinical trial that compares the effects of cognitive behavioral therapy (CBT) and supportive psychotherapy for depression. Short- and long-term outcomes will be evaluated in terms of changes in mood (primarily depression and anxiety), participation in activities and life satisfaction.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Goals Demonstrate the efficacy of cognitive behavioral therapy (CBT), both immediately after treatment and in the long term, in alleviating post-TBI depression.

Examine the relationship between improved mood, participation, and life satisfaction.

Implement exploratory analyses of the relationships between person and injury characteristics and outcomes of treatment.

Maximize potential application to clinical practice by:

Implementing the treatment in a clinical context so that its utility is demonstrated in a setting that maximizes ecological validity, and Creating and disseminating a manual detailing CBT treatment. This study is a randomized clinical trial that compares two treatment conditions: CBT and supportive psychotherapy (SPT). CBT has been shown to be effective in diverse studies. In this study, CBT has been shaped to be used specifically with people with typical post-TBI cognitive challenges. All participants will be given an opportunity to immediately receive a randomly assigned psychotherapy intervention to potentially enhance coping. Both CBT and SPT will involve 16 sessions of individual treatment. The initial session will be 90 minutes, with remaining sessions 50 minutes. In both treatments, participants will be seen for three months, with sessions twice weekly for the first month and once a week subsequently. The research assistants who will administer pre- and postintervention evaluation instruments will be blind to each participant's randomly assigned treatment condition. Evaluation instruments will be administered at baseline and at three points of follow-up: one week, six months, and one year after treatment. A detailed manual describing treatment methods will be developed based on the intervention.

Tipo de estudio

Intervencionista

Inscripción (Actual)

75

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

  • Estados Unidos
    • New York
      • New York, New York, Estados Unidos, 10029-6574
        • Icahn School of Medicine at Mount Sinai

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

Inclusion Criteria:

  • Being at least 18years old
  • Having a TBI as a result of a blow to the head followed by a loss of consciousness or period of being dazed and confused or a period of post traumatic amnesia or clinical signs of altered neurological function; this information must be medically documented (e.g., emergency medical record, hospital record, neuroradiological report, or neurological exam or record of physician's visit within 24 hours of injury)
  • Being at least 6 months post injury
  • Being English-speaking
  • Having residential telephone service
  • Living within 1.5 hours of New York City
  • Having at least a sixth-grade reading level
  • Meeting DSM-IV criteria for a current depressive mood disorder
  • Not being in psychotherapy and being willing to abstain from seeking psychotherapy during the course of participation
  • Being willing to complete questionnaires and interviews about mood, thinking skills, community participation and life satisfaction
  • Agreeing to participate, verified by completion of informed consent and HIPAA documents.
  • Individuals who meet criteria and are currently using prescribed mood medications will be included in the study if dosage has been stable for sixty days.

Exclusion Criteria:

  • Pre-existing neurological disorder, including brain injury from an etiology other than trauma
  • History of mental retardation
  • Lack of capacity to sign informed consent
  • Taking antidepressant medications for less than six months
  • Having any changes in antidepressant medications in the last six months
  • History of current or past psychosis or mania
  • Current substance abuse

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
Experimental: Treatment Arm 1
Individual psychotherapy focused on identifying and correcting maladaptive cognitions and behaviors with the goal of improving mood. The intervention has adapted CBT specifically to address cognitive deficits associated with TBI, which compound the cognitive distortions typical of depression. CBT therapists embed compensatory strategies within treatment sessions to address cognitive limitations of each participant.
Conductual: Cognitive behavioral therapy
Individual psychotherapy focused on identifying and correcting maladaptive cognitions and behaviors with the goal of improving mood. The intervention has adapted CBT specifically to address cognitive deficits associated with TBI, which compound the cognitive distortions typical of depression. CBT therapists embed compensatory strategies within treatment sessions to address cognitive limitations of each participant.
Experimental: Treatment Arm 2
A client-centered individual psychotherapy treatment approach designed to address depressive disorders commonly experienced by individuals following a TBI. In line with traditional supportive psychotherapy approaches, the objective of SPT is to improve the individual's ability to deal with problems of daily living more effectively through problem identification, praise, reassurance, encouragement, psychoeducation, advice, anticipatory guidance, and expanding awareness.
Conductual: Supportive psychotherapy
A client-centered individual psychotherapy treatment approach designed to address depressive disorders commonly experienced by individuals following a TBI. In line with traditional supportive psychotherapy approaches, the objective of SPT is to improve the individual's ability to deal with problems of daily living more effectively through problem identification, praise, reassurance, encouragement, psychoeducation, advice, anticipatory guidance, and expanding awareness.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Remission of depression (DSM-IV diagnosis no longer met)
Periodo de tiempo: baseline
baseline
Remission of depression (DSM-IV diagnosis no longer met)
Periodo de tiempo: one week after treatment completion
one week after treatment completion
Remission of depression (DSM-IV diagnosis no longer met)
Periodo de tiempo: six months after treatment completion
six months after treatment completion
Remission of depression (DSM-IV diagnosis no longer met)
Periodo de tiempo: one year after treatment completion
one year after treatment completion

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Increased participation (Participation Objective, Participation Subjective)
Periodo de tiempo: baseline
baseline
Improved quality of life (Life-3).
Periodo de tiempo: baseline
baseline
Increased participation (Participation Objective, Participation Subjective)
Periodo de tiempo: one week after treatment completion
one week after treatment completion
Increased participation (Participation Objective, Participation Subjective)
Periodo de tiempo: six months after treatment completion
six months after treatment completion
Increased participation (Participation Objective, Participation Subjective)
Periodo de tiempo: one year after treatment completion
one year after treatment completion
Improved quality of life (Life-3).
Periodo de tiempo: one week after treatment completion
one week after treatment completion
Improved quality of life (Life-3).
Periodo de tiempo: six months after treatment completion
six months after treatment completion
Improved quality of life (Life-3).
Periodo de tiempo: one year after treatment completion
one year after treatment completion

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Icahn School of Medicine at Mount Sinai

Colaboradores

U.S. Department of Education

Investigadores

  • Investigador principal: Wayne Gordon, Ph.D., Icahn School of Medicine at Mount Sinai

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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

1 de noviembre de 2005

Finalización primaria (Actual)

1 de diciembre de 2010

Finalización del estudio (Actual)

1 de diciembre de 2010

Fechas de registro del estudio

Enviado por primera vez

13 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

13 de septiembre de 2005

Publicado por primera vez (Estimar)

21 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de septiembre de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

20 de septiembre de 2013

Última verificación

1 de septiembre de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GCO 04-0782
  • H133B040033

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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