Cognitive Processing Therapy for Syrian Patients With PTSD

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder (PTSD)
• Interventions: Behavioral: Cognitive Processing Therapy (CPT)

• Registration Number: NCT05031728
• Lead Sponsor: British University In Egypt

Brief Summary

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.

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 Timeline

• Study Start: 2017-01-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-01-01
• Study First Submitted: 2021-08-17
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Study First Posted: 2021-09-02
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPT Group	Cognitive Processing Therapy (CPT)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The British university in Egypt; 🇪🇬 Cairo, Egypt