Treatment of Pediatric Obsessive-Compulsive Disorder
Cognitive Behavior Therapy
+ Educational Support
+ Sertraline
Trastornos de Ansiedad
+ Trastornos Mentales
+ Trastorno Obsesivo-Compulsivo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 1997
Fecha en la que se inscribió al primer participante.To contrast the degree and durability of improvement in pediatric obsessive-compulsive disorder (OCD), patients will be treated with 1 of 6 conditions (3 active treatments and 3 control treatments): sertraline alone (SER), OCD-specific Cognitive Behavior Therapy (CBT), both SER and CBT (SER plus CBT), pill placebo (PBO), pill PBO plus Educational Support (ES), and SER plus ES. One in 200 youth suffers from OCD, yet relatively few receive appropriate treatment. Both CBT and medication appear beneficial in controlled studies; however, the relative efficacy of CBT and medication, alone and in combination (COMB) is unknown. Thus, well-designed treatment outcome studies are necessary to improve care for youth with OCD. The experimental design covers 2 phases. Phase I is a 2 (site) x 2 (SER or pill PBO) x 3 (CBT, ES or non- psychosocial treatment) x 5 (repeated measures) factorial 12-week comparison of SER, CBT, COMB and the control conditions. In Phase II, responders advance to a 16-week discontinuation study to assess treatment durability. The primary outcome measure is the Yale-Brown Obsessive-Compulsive Scale. Assessments blind to treatment status take place at Week 0 (pretreatment); Weeks 1, 4, 8, 12 (Phase I treatment); and Weeks 16, 20, 24 and 28 (Phase II discontinuation). Besides addressing comparative efficacy and durability of the specified treatments, the investigators also examine time-action effects, differential effects on specific aspects of OCD, including functional impairment, and predictors of response to treatment.
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 8 a 16 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: DSM-IV diagnosed OCD.
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 2 ubicaciones
Univ of Pennsylvania
Philadelphia, United States