- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00245232
Cognitive Processing Therapy Versus Its Individual Components in the Treatment of Post-Traumatic Stress Disorder and Depression in Women Who Have Been Sexually Abused
Cognitive Processes in PTSD: Treatment
Aperçu de l'étude
Statut
Les conditions
Description détaillée
PTSD is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. This study will evaluate the effectiveness of cognitive processing therapy versus its individual components in treating women with post-traumatic stress disorder and depression brought on by sexual assault.
Participants in this single-blind study will be randomly assigned to receive one of three treatments: cognitive processing therapy (CPT); cognitive therapy (CT); or written exposure (WE). Participants assigned to receive either CPT or CT will attend therapy sessions twice weekly for 6 weeks. CPT will focus on helping each individual to process accurate memories of the traumatic event and to work through any memories that cannot be completely ignored, nor completely integrated back into their thinking. Also included in CPT will be a WE component, in which participants will be encouraged to recall the traumatic event and experience any emotions connected to it. CT will be similar to CPT, but will not include the WE component. Participants assigned to receive only WE will attend one 2-hour session each week. Symptoms of PTSD and depression will be measured at baseline, post-treatment, and at a 6-month follow-up visit.
Type d'étude
Inscription
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Missouri
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St. Louis, Missouri, États-Unis, 63121-4499
- Center for Trauma and Recovery, University of Missouri - St. Louis
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- History of a discrete episode of assault in childhood or adulthood
- Meets criteria for post-traumatic stress disorder
Exclusion Criteria:
- Experienced a traumatic event that was in the form of chronic ongoing abuse and not a discrete incidence
- Psychosis
- Mental retardation
- Suicidal or parasuicidal
- Currently addicted to drugs
- Illiterate
- Currently in an abusive relationship
- Currently being stalked
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Depression symptoms; measured immediately post-treatment and 6 months post-treatment
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Post-traumatic stress disorder symptoms; measured immediately post-treatment and 6 months post-treatment
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Patricia A. Resick, PhD, National Center for PTSD, Women's Health Sciences Division
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01MH051509-06 (Subvention/contrat des NIH des États-Unis)
- DSIR AT-AS
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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