Cognitive Processing Therapy for Syrian Patients With PTSD (CPT4Syrians)

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder (PTSD)
• Intervention / Treatment: Behavioral: Cognitive Processing Therapy (CPT)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11837
    • The British University in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Behavioral: Cognitive Processing Therapy (CPT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessing change in CAPS-5 scores between three time points	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).	baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessing change in Beck Depression Inventory (BDI-II) scores between three time points	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.	baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
assessing change in Beck Anxiety Inventory (BAI) scores between three time points	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

Collaborators and Investigators

• Sponsor: British University In Egypt
• Investigators: Principal Investigator: Amani S Elbarazi, Ph.D., The British University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Cognitive Processing Therapy (CPT); Posttraumatic stress disorder (PTSD); Syrians
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: BritishUE20-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: individual participant data (IPD) will be available to other researchers
• IPD Sharing Time Frame: January 2022
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No