Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT00889005
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2009-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D040701', 'term': 'Stress Disorders, Traumatic, Acute'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arieh.shalev@nyumc.org', 'phone': '6467544782', 'title': 'Arieh Y. Shalev, M.D.', 'organization': 'New York Langone Medical Center Department of Psychiatry'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cognitive Behavioral Therapy', 'description': 'Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.\n\nTelephone Based Cognitive Behavioral Therapy: Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment', 'otherNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Waitlist Control Group', 'description': 'Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.', 'otherNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Severity of PTSD Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy', 'description': 'Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.\n\nTelephone Based Cognitive Behavioral Therapy: Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment'}, {'id': 'OG001', 'title': 'Waitlist Control Group', 'description': 'Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'groupId': 'OG000', 'lowerLimit': '33.9', 'upperLimit': '45.8'}, {'value': '43.9', 'groupId': 'OG001', 'lowerLimit': '41.3', 'upperLimit': '51.6'}]}]}], 'analyses': [{'pValue': '0.927', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to ten months', 'description': 'Clinician Administered PTSD Scale for DSM IV (CAPS IV) Score range 0-136 points Score above 40 indicate probable PTSD PTSD diagnosis inferred using DSM IV diagnostic criteria', 'unitOfMeasure': 'CAPS total Score at treatment end', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Survivors of traumatic event with Acute PTSD symptoms one month after trauma exposure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitive Behavioral Therapy', 'description': 'Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.\n\nTelephone Based Cognitive Behavioral Therapy: Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment'}, {'id': 'FG001', 'title': 'Waitlist Control Group', 'description': 'Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Behavioral Therapy', 'description': 'Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.\n\nTelephone Based Cognitive Behavioral Therapy: Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment'}, {'id': 'BG001', 'title': 'Waitlist Control Group', 'description': 'Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.83', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '37.95', 'spread': '12.71', 'groupId': 'BG001'}, {'value': '37.89', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Israel', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Recent trauma survivors recruited following admission to a general hospital emergency room following traumatic events. Consecutive survivors screened and enrolled if eligible'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-20', 'studyFirstSubmitDate': '2009-04-26', 'resultsFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2009-04-26', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-20', 'studyFirstPostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of PTSD Symptoms', 'timeFrame': 'Up to ten months', 'description': 'Clinician Administered PTSD Scale for DSM IV (CAPS IV) Score range 0-136 points Score above 40 indicate probable PTSD PTSD diagnosis inferred using DSM IV diagnostic criteria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post-traumatic Stress Disorder', 'Acute Stress Disorder', 'Cognitive behavioral therapy', 'Secondary Prevention', 'Anxiety disorders', 'Service Delivery'], 'conditions': ['Stress Disorder - Post-traumatic (Acute)']}, 'descriptionModule': {'briefSummary': "This is a randomized controlled study comparing telephone-based cognitive behavioral therapy (CBT) for recent survivors of traumatic events with Acute Stress Disorder (ASD) or acute PTSD with a waitlist control group. Survivors with PTSD from both groups will receive face-to-face CBT one month from the traumatic event. The study's main hypothesis is that early telephone-based CBT will reduce the prevalence of PTSD three and eight months after the traumatic event.", 'detailedDescription': "Post-traumatic Stress Disorder (PTSD) is a prevalent and pervasive mental disorder. Studies have shown that there is a significant reluctance to use mental health services by trauma-exposed individuals at high risk for developing PTSD. Providing clinical services in combat or disaster zone might be difficult. Trauma-focused cognitive behavioral therapy (CBT) effectively reduces the prevalence of PTSD among recent survivors. Telephone based CBT was found to be effective in mood and anxiety disorders, but has not been tried in PTSD. Establishing the effectiveness of telephone based CBT has significant service delivery and public health implications. Preventing PTSD significantly reduces individuals' suffering and disability We will screen, by telephone, up to 1200 survivors of traumatic events, from a general hospital emergency department trauma registry list, randomize the first 240 with ASD or Acute PTSD to either early, telephone based cognitive behavioral therapy (ET\\_CBT) (n=120) or a no-treatment control condition (n=120). We will provide five sessions of ET-CBT to the former and compare the two groups three and eight months later.\n\nSurvivors from both groups who will continue to have PTSD at three months (after either treatment or waiting list), will receive 12 sessions of face-to-face, trauma focused CBT. A first phase of the study will consist of establishing the acceptance of ET-CBT and its main components (e.g., exposure to traumatic reminders) by survivors, and optimizing the protocol. It will involve 20 survivors and no randomization. Subsequent to that phase we will start recruiting for the main study. The study's main hypothesis is that early CBT will reduce the prevalence of PTSD three and eight months after the traumatic event."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults\n* Exposure to psychologically traumatic events\n* Diagnosis of Acute Stress Disorder or Post-traumatic Stress Disorder\n* Up to four weeks after trauma exposure\n\nExclusion Criteria:\n\n* Chronic PTSD\n* Past and present psychosis, bipolar disorder, opiate or stimulants use\n* Medical or surgical condition that interfere with subjects ability to participate in the study or sign an informed consent\n* Lack of fluency in the study's main language (Hebrew)"}, 'identificationModule': {'nctId': 'NCT00889005', 'briefTitle': 'Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy', 'orgStudyIdInfo': {'id': 'Shalev_Phone_2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Therapy', 'description': 'Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.', 'interventionNames': ['Other: Telephone Based Cognitive Behavioral Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control group', 'description': 'Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.'}], 'interventions': [{'name': 'Telephone Based Cognitive Behavioral Therapy', 'type': 'OTHER', 'description': 'Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment', 'armGroupLabels': ['Cognitive Behavioral Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah University Hospital', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Arieh Y Shalev, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah University Hospital, Jerusalem'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Aria Shalev', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}