Cognitive Processing Therapy for Syrian Patients With PTSD

NCT05031728 | Completed DMC

• 1 other identifier: BritishUE20-21
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

Cognitive Processing Therapy (CPT); Posttraumatic stress disorder (PTSD); Syrians

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (1)

CPT Group

EXPERIMENTAL

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)

Interventions

Cognitive Processing Therapy (CPT) BEHAVIORAL

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.

CPT Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• having mental retardation
• having schizophrenia (or any other psychotic disorders).

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British university in Egypt

Cairo, 11837, Egypt

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Amani S Elbarazi, Ph.D.

  The British University in Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: September 2, 2021
• Study Start: January 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 2022
• 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.

Locations

EG (1)