Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT03469128
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2018-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Processing Therapy vs. Sertraline for the Treatment of PTSD & SUD in Egyptian Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-01', 'size': 675384, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-30T15:55', 'hasProtocol': True}, {'date': '2016-01-01', 'size': 274079, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_004.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-30T15:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2018-03-12', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire', 'timeFrame': '3 Months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PTSD', 'CPT', 'SUD'], 'conditions': ['Psychologic Manipulation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with SUD\n\nExclusion Criteria:\n\n* Patients diagnosed with other psychotic disorders'}, 'identificationModule': {'nctId': 'NCT03469128', 'briefTitle': 'Cognitive Processing Therapy vs. Sertraline for the Treatment of PTSD & SUD in Egyptian Patients', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'Cognitive Processing Therapy Versus Sertraline for the Treatment of Post-traumatic Stress Disorder & Substance Use Disorder Egyptian Patients', 'orgStudyIdInfo': {'id': '2016-2017PTBUE'}, 'secondaryIdInfos': [{'id': 'IRB Protocol CL-006', 'type': 'REGISTRY', 'domain': 'the British University in Egypt Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive processing therapy', 'description': 'Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT', 'interventionNames': ['Behavioral: Cognitive processing therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sertraline', 'description': 'Patients with co-occurrence PTSD \\& SUD disorders were treated by Sertraline.', 'interventionNames': ['Drug: Sertraline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Placebo Control group', 'interventionNames': ['Other: Placebo Control']}], 'interventions': [{'name': 'Cognitive processing therapy', 'type': 'BEHAVIORAL', 'description': 'Psychological treatment for patients suffering from PTSD and SUD symptoms.', 'armGroupLabels': ['Cognitive processing therapy']}, {'name': 'Sertraline', 'type': 'DRUG', 'otherNames': ['SSRI'], 'description': 'Sertraline for the treatment of post-traumatic stress and SU disorders', 'armGroupLabels': ['Sertraline']}, {'name': 'Placebo Control', 'type': 'OTHER', 'description': 'Placebo Control', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Amani Elbarazi, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The British University in Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amani Safwat Albrazi', 'investigatorAffiliation': 'British University In Egypt'}}}}