Cognitive Processing Therapy for Syrian Patients With PTSD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive Processing Therapy for the Treatment of Post-Traumatic Stress Disorder in Syrian Patients

Conditions
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Posttraumatic Stress Disorder (PTSD)

Intervention / Treatment
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* Behavioral: Cognitive Processing Therapy (CPT)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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 post treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPT Group<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic stress disorder (PTSD), Syrians, Cognitive Processing Therapy (CPT)