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

NCT ID: NCT03469128

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2020-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Psychologic Manipulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Data were obtained by interviewing 587 patients diagnosed with SUD. Patients were interviewed by a clinician and asked to complete: Mini-International Neuropsychiatric Interview (M.I.N.I), and Clinician-Administered PTSD Scale (CAPS). Patients with comorbid SUD and PTSD were asked to complete: The Brief Addiction Monitor (BAM), PTSD Checklist-Civilian (PCL-5), Beck Depression Inventory (BDI-II), and Timeline Follow Back Interview (TLFB). Patients with comorbid SUD and PTSD were randomized to one of the following groups: 1) received CPT. 2) received Sertraline. 3) the Placebo control group.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
This is a three-group, repeated-measure, parallel-group, Randomized Control Trial design. Patients, study psychiatrists, and assessors were blind to treatment condition assignment. Randomization blocks of three were used to maintain equal group size. The 3-month assessment serves as the post-treatment. Outcome assessments were PTSD severity, substance use severity, and depression. The pharmacy of Ain Shams Hospital created sertraline and matching placebo kits with single-identifier numbers based on a random code that was provided to an unblinded statistician who will instruct the psychiatrist how to distribute kits to patients.

Study Groups

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Cognitive processing therapy

Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT

Group Type ACTIVE_COMPARATOR

Cognitive processing therapy

Intervention Type BEHAVIORAL

Psychological treatment for patients suffering from PTSD and SUD symptoms.

Sertraline

Patients with co-occurrence PTSD \& SUD disorders were treated by Sertraline.

Group Type ACTIVE_COMPARATOR

Sertraline

Intervention Type DRUG

Sertraline for the treatment of post-traumatic stress and SU disorders

Control group

Placebo Control group

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type OTHER

Placebo Control

Interventions

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Cognitive processing therapy

Psychological treatment for patients suffering from PTSD and SUD symptoms.

Intervention Type BEHAVIORAL

Sertraline

Sertraline for the treatment of post-traumatic stress and SU disorders

Intervention Type DRUG

Placebo Control

Placebo Control

Intervention Type OTHER

Other Intervention Names

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SSRI

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with SUD

Exclusion Criteria

* Patients diagnosed with other psychotic disorders
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British University In Egypt

OTHER

Sponsor Role lead

Responsible Party

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Amani Safwat Albrazi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amani Elbarazi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The British University in Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB Protocol CL-006

Identifier Type: REGISTRY

Identifier Source: secondary_id

2016-2017PTBUE

Identifier Type: -

Identifier Source: org_study_id

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