Cognitive Processing Therapy vs. Sertraline for the Treatment of PTSD & SUD in Egyptian Patients

March 30, 2021 updated by: Amani Safwat Albrazi, British University In Egypt

Cognitive Processing Therapy Versus Sertraline for the Treatment of Post-traumatic Stress Disorder & Substance Use Disorder Egyptian Patients

The present research was aimed at comparing the effects of Cognitive Processing Therapy (CPT) with the effects of Sertraline in treating patients who have dual diagnosis PTSD & SUD. The present study examines the extent to which CPT is effective in treating PTSD symptoms for patients with PTSD and SUD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with co-occurrence PTSD & SUD disorders were grouped into 3 groups: first: Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT. Second: were treated by Sertraline. Third: a placebo control group.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with SUD

Exclusion Criteria:

  • Patients diagnosed with other psychotic disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive processing therapy
Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT
Behavioral: Cognitive processing therapy
Psychological treatment for patients suffering from PTSD and SUD symptoms.
Active Comparator: Sertraline
Patients with co-occurrence PTSD & SUD disorders were treated by Sertraline.
Drug: Sertraline
Sertraline for the treatment of post-traumatic stress and SU disorders
Other Names:
  • SSRI
Placebo Comparator: Control group
Placebo Control group
Other: Placebo Control
Placebo Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire
Time Frame: 3 Months
A psychological parameter will be measured to check the efficacy of CPT against medication for the treatment for co-current PTSD & SUD. The groups will be examined to show if any significant reductions in PTSD and SUD symptoms was obtained over time.
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British University In Egypt

Investigators

  • Principal Investigator: Amani Elbarazi, Ph.D., The British University in Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-2017PTBUE
  • IRB Protocol CL-006 (Registry Identifier: the British University in Egypt Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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