- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05031728
Cognitive Processing Therapy for Syrian Patients With PTSD (CPT4Syrians)
Cognitive Processing Therapy for the Treatment of Post-Traumatic Stress Disorder in Syrian Patients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Cairo, Egypte, 11837
- The British University in Egypt
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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 Their nationalities are Syrians
- age older than 18 years and younger than 65,
- patients meeting current diagnostic criteria for PTSD as defined in DSM-5
- have a good knowledge of English-language (reading, writing, and comprehension) because all assessments and therapy materials were in English
Exclusion Criteria
- having mental retardation
- having schizophrenia (or any other psychotic disorders).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: CPT Group
Cognitive Processing Therapy (CPT) is employed.
Each patient will attend 12 individual sessions with the therapist.
The sessions will be on the weekly basis.
The standard manual of CPT (Resick et al., 2016) is going to be employed.
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Cognitive processing therapy (CPT) (Resick et al., 2016) which is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of Post-Traumatic Stress Disorder (PTSD) that may have developed after experiencing a variety of traumatic events including child abuse, emotional abuse, combat, rape war, and natural disasters.
CPT helps patients learn how to challenge and modify unhelpful beliefs related to the trauma and emotional pain.
In so doing, the client creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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assessing change in CAPS-5 scores between three time points
Délai: baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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Clinician-Administered PTSD Scale (CAPS-5; Weathers et al., 2015) is currently the gold- standard assessment for PTSD and is used to assess PTSD's symptoms at pre-intervention, immediately post- intervention, and 12-month after the intervention.
This 30-item structured interview was developed by staff at the U.S. Department of Veterans Affairs National Center for PTSD.
The interview can generally be administered in 45-60 minutes.
Each question in CAPS asks about both the frequency and the severity of each PTSD symptom.
These questions are split into categories.
Each criterion has several questions, and scores for each criterion are added up at the end.
The CAPS-5 has demonstrated strong psychometric properties (Weathers, et al., 2018).
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baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
assessing change in Beck Depression Inventory (BDI-II) scores between three time points
Délai: baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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Beck Depression Inventory (BDI-II): was used to evaluate the change in the severity of depressive symptoms between three time points.
BDI-II is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1996).
The BDI takes approximately 10 minutes to complete.
Depression levels were defined as follows: minimal range = 0- 13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29- 63.
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baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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assessing change in Beck Anxiety Inventory (BAI) scores between three time points
Délai: baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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Beck Anxiety Inventory (BAI): was used to evaluate the change in the severity of anxiety severity between three time points. BAI was developed by Dr. Aaron T. Beck and it is a brief measure of anxiety with a focus on somatic symptoms of anxiety such as nervousness, dizziness, inability to relax (Beck et al., 1988). It has a total of 21 items that takes approximately 10-15 minutes to complete. Answers are on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The values for each item are summed yielding an overall or total score for all 21 symptoms that can range between 0 and 63 points. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 -25 as "Moderate", and 26 - 63 as "Severe". |
baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Amani S Elbarazi, Ph.D., The British University in Egypt
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BritishUE20-21
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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Essais cliniques sur Cognitive Processing Therapy (CPT)
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University of WashingtonNational Institute on Drug Abuse (NIDA)ComplétéTroubles liés à l'utilisation de substances | Troubles de stress post-traumatique | Sexe à risqueÉtats-Unis
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The University of Texas Health Science Center at...ComplétéTroubles de stress, post-traumatique | AcouphèneÉtats-Unis
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British University In EgyptComplétéLa dépression | SSPT | AnxiétéEgypte
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Hampton VA Medical CenterRésiliéTrouble de stress post-traumatique | Trouble de stress, post-traumatiqueÉtats-Unis
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University of Wisconsin, MadisonUS Department of Veterans AffairsComplétéTrouble de stress post-traumatiqueÉtats-Unis
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Duke UniversityComplété
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VA Office of Research and DevelopmentPas encore de recrutement
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Boston VA Research Institute, Inc.United States Department of Defense; University of TexasComplété
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VA Pacific Islands Health Care SystemComplétéTrouble de stress post-traumatiqueÉtats-Unis
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University of Wisconsin, MadisonComplété