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Cognitive Processing Therapy Versus Medication for the Treatment of Post Traumatic Stress Disorder & Substance Use Disorder Egyptian Patients

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ClinicalTrials.gov Identifier: NCT03469128
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bassam Mahfouz Ayoub, British University In Egypt

Brief Summary:
The present research was aimed at comparing the effects of the Cognitive Processing Therapy (CPT) with the effects of medicine in treating the 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.

Condition or disease Intervention/treatment Phase
Psychologic Manipulation Other: Cognitive processing therapy Drug: Disulfiram Other: Waiting list Phase 1

Detailed Description:
Participants were grouped into 3 groups: first: Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT. Second: Medication group in which patients with co-occurrence PTSD & SUD disorders were treated by medicine (Disulfiram, Naltrexone and Buprenorphine). Third: control group that consists of patients with co-occurrence PTSD & SUD disorders who were not treated yet (waiting lists in the hospital).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: participants were grouped into the following groups: first: Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT. Second: Medication group in which patients with co-occurrence PTSD & SUD disorders were treated by medicine (Disulfiram, Naltrexone and Buprenorphine). Third: control group that consists of patients with co-occurrence PTSD & SUD disorders who were not treated yet (waiting lists in the hospital).
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Cognitive Processing Therapy Versus Medication for the Treatment of Post Traumatic Stress Disorder & Substance Use Disorder Egyptian Patients
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Disulfiram

Arm Intervention/treatment
Active Comparator: Cognitive processing therapy
Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT
Other: Cognitive processing therapy
Psychological treatment for patients suffering from post traumatic symptoms.

Active Comparator: Medication
Medication group in which patients with co-occurrence PTSD & SUD disorders were treated by medicine (Disulfiram).
Drug: Disulfiram
Medicine for the treatment of post traumatic stress disorder

Placebo Comparator: Control group
Control group that consists of patients with co-occurrence PTSD & SUD disorders who were not treated yet (waiting lists in the hospital).
Other: Waiting list
The control group was selected from the Hospital waiting list of patients




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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with PTSD & SUD

Exclusion Criteria:

  • Patients diagnosed with other psychiatric disorders

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Responsible Party: Bassam Mahfouz Ayoub, Principal Investigator, British University In Egypt
ClinicalTrials.gov Identifier: NCT03469128     History of Changes
Other Study ID Numbers: 2016-2017PTBUE
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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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

Keywords provided by Bassam Mahfouz Ayoub, British University In Egypt:
PTSD
CPT
SUD

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Substance-Related Disorders
Trauma and Stressor Related Disorders
Mental Disorders
Chemically-Induced Disorders
Disulfiram
Alcohol Deterrents
Acetaldehyde Dehydrogenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action