Cognitive Processing Therapy for Syrian Patients With PTSD (CPT4Syrians)
1 de septiembre de 2021 actualizado por: Amani Safwat Albrazi, British University In Egypt
Cognitive Processing Therapy for the Treatment of Post-Traumatic Stress Disorder in Syrian Patients
Background: Studies among Syrian refugees showed high prevalence rates of PTSD.
The objective of the present study was to investigate the effectiveness of Cognitive Processing Therapy (CPT) in treating patients with posttraumatic stress disorder (PTSD) using a clinical trial.
Methods: Data will be obtained through interviewing patients seeking for PTSD treatment.
Patients will be interviewed by a clinician and asked to complete the Clinician-Administered PTSD Scale (CAPS-5), Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI).
Assessments will be conducted at baseline, 3-, and 12-months posttreatment.
The primary outcomes will be the scores of CAPS, BDI-II, and BAI.
Results: we predict that CPT will result in greater reductions in CAPS scores.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Although individuals with PTSD experience significant suffering, disability, and a challenging clinical course, there are still significant gaps in the evidence addressing effective treatment options.
Therefore, in the current study CPT will determine the effectiveness in treating Syrian patients with PTSD.
Current study significantly adds to the existing literature.
It is a novel study in Egypt and adds to the literature.
Tipo de estudio
Intervencionista
Inscripción (Actual)
94
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
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Cairo, Egipto, 11837
- the British University in Egypt
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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 a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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 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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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assessing change in CAPS-5 scores between three time points
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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assessing change in Beck Depression Inventory (BDI-II) scores between three time points
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Amani S Elbarazi, Ph.D., the British University in Egypt
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 (Actual)
1 de enero de 2017
Finalización primaria (Actual)
1 de diciembre de 2020
Finalización del estudio (Actual)
1 de enero de 2021
Fechas de registro del estudio
Enviado por primera vez
17 de agosto de 2021
Primero enviado que cumplió con los criterios de control de calidad
1 de septiembre de 2021
Publicado por primera vez (Actual)
2 de septiembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de septiembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
1 de septiembre de 2021
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BritishUE20-21
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
individual participant data (IPD) will be available to other researchers
Marco de tiempo para compartir IPD
January 2022
Criterios de acceso compartido de IPD
Direct access to the patients' data will be granted to authorized representatives from the Sponsor and host hospital for monitoring and/or audit of the study to ensure compliance with regulations.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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