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| ID | Type | Description | Link |
|---|---|---|---|
| IRB Protocol CL-006 | Registry Identifier | the British University in Egypt Institutional Review Board |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive processing therapy | Active Comparator | Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT |
|
| Sertraline | Active Comparator | Patients with co-occurrence PTSD & SUD disorders were treated by Sertraline. |
|
| Control group | Placebo Comparator | Placebo Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive processing therapy | Behavioral | Psychological treatment for patients suffering from PTSD and SUD symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amani Elbarazi, Ph.D. | The British University in Egypt | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2016 | Mar 30, 2021 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2016 | Mar 30, 2021 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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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.
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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.
| Sertraline | Drug | Sertraline for the treatment of post-traumatic stress and SU disorders |
|
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| Placebo Control | Other | Placebo Control |
|
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |