Treatment of Outcomes of Fluoxetine vs EMDR in PTSD
Fluoxetine
+ EMDR
Trastornos Relacionados con el Estrés y el Trauma
+ Trastornos Mentales
+ Trastornos de Estrés Postraumático
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de enero de 1999
Fecha en la que se inscribió al primer participante.To compare the short-term and long-term efficacy of two different treatment approaches in widespread use in clinical settings for treating patients with post-traumatic stress disorder (PTSD): fluoxetine (which acts directly on biological systems) vs a psychological treatment, Eye Movement Desensitization and Reprocessing (EMDR). To clarify: 1) the differential treatment effects of these different treatment modalities; 2) whether symptom improvement is accompanied by changes in pathophysiology; and 3) the long-term effectiveness of these treatments. In recent years a variety of treatment approaches have been shown to be effective in the treatment of PTSD. These include prolonged exposure therapies (PE), stress inoculation training (SIT), EMDR and psychopharmacological treatment with serotonin re-uptake blockers. While PE has been compared with SIT and a study is currently under way comparing cognitive-behavioral treatment with EMDR, no study as yet has compared the relative merits of pharmacotherapy alone vs an exposure treatment. While it is commonly held that, in order to recover, people with PTSD need to "process" their traumatic memories, treatments that do not involve the processing of traumatic memories (such as SIT or pharmacotherapy) may be just as effective. In clinical practice, many patients with PTSD appear to be effectively treated with pharmacological agents alone, without trauma-focused therapy. Patients are randomly assigned to one of three conditions: 1) a double-blind psychopharmacological treatment (fluoxetine); 2) a manualized treatment which focuses on "processing" traumatic memories (EMDR); or 3) a placebo control group. After 8 weeks of active treatment, subjects are evaluated, cease treatment, and are assessed again after another 8 weeks and at 6 months in order to evaluate the long-term effects. Training raters remain blind to the subjects' treatment condition throughout the study. Treatment outcome is assessed with a multi-modal psychological and biological assessment battery including: 1) standard psychological tests for PTSD (CAPS); 2) neuroendocrine function (cortisol); and 3) psychophysiological response to traumatic scripts (pre-post changes in heart social and occupational functioning). Treatment adherence is monitored throughout the study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 65 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: - Patients must have: Post-Traumatic Stress Disorder (PTSD).
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación