Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-22 @ 3:06 AM
Study NCT ID:
NCT01959620
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2013-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Dose of Early Intervention to Prevent PTSD
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-19', 'studyFirstSubmitDate': '2013-10-06', 'studyFirstSubmitQcDate': '2013-10-08', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PTSD Symptom Scale-I (PSS)', 'timeFrame': 'Measured 1, 3, 6, 12 months post-trauma'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PTSD'], 'conditions': ['Posttraumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to determine the optimal dose, 3-session exposure intervention versus 1-session exposure intervention compared to no treatment, for the delivery of exposure therapy in the immediate aftermath of trauma for preventing the development of posttraumatic stress disorder.', 'detailedDescription': 'The precipitant for adult posttraumatic stress disorder (PTSD) is a known event, which allows for immediate intervention and presents the potential to prevent the occurrence of this serious condition. However, there currently are no accepted interventions for the early intervention and prevention of PTSD in the immediate aftermath of trauma. This study will determine whether providing exposure therapy to people who have recently experienced trauma will significantly reduce the severity of PTSD symptoms post-trauma and if delivery of three exposure sessions will result in larger reductions in the symptoms of PTSD post-trauma than one exposure session. This study will also examine predictors for treatment response.\n\nParticipation in this study will last 12 months. Participants will first undergo an evaluation session that will include an interview and questionnaires. They will then be randomly assigned to one of the following three conditions: 1-session exposure therapy, 3-session exposure therapy, or assessment only. Participants receiving 1-session exposure therapy will complete one treatment session in the emergency department (ED). Participants receiving 3-session exposure therapy will complete three weekly treatment sessions, with the first occurring in the ED. Treatment will involve reviewing memories of a recent trauma out loud with a therapist and audio-recording these discussions for review at home. All participants will undergo assessments 1, 3, 6, and 12 months after the initial evaluation session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presenting to the emergency department of Emory University School of Medicine/Grady Memorial Hospital for trauma in the past 72 hours\n* Meets DSM-IV diagnostic criterion A in which both of the following are present: (i) The person experienced, witnessed, or was confronted with an event or events that involved actual or threatened death or serious injury or a threat to the physical integrity of self or others (ii) The person's response involved intense fear, helplessness, or horror\n* Speaks and understands spoken English\n* Have a memory of what happened during the trauma\n* Can see the assessment forms, hear instructions, and function at an emotional and intellectual level sufficient to allow accurate completion of all assessment instruments\n\nExclusion Criteria:\n\n* Current or history of mania, schizophrenia, or other psychoses\n* Current (past month) prominent suicidal ideation or recent (past 3 months) parasuicidal behavior or other self-injurious behavior, such as low lethality cutting\n* Current (past month) substance dependence; people who meet criteria for current substance abuse but not dependence, or past dependence and have been in remission for at least 1 month are eligible\n* Experienced a loss of consciousness for more than 5 minutes as a result of injuries sustained during the trauma\n* Intoxicated, altered, or highly distressed to the degree that accurate completion of the study assessments or participation in study procedures is not possible\n* Blood alcohol level above .08, determined by breathalyzer in the emergency department\n* Not alert, oriented, and coherent\n* In severe pain, active labor, or respiratory distress or hemodynamically compromised in any way"}, 'identificationModule': {'nctId': 'NCT01959620', 'briefTitle': 'Optimal Dose of Early Intervention to Prevent PTSD', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Optimal Dose of Early Intervention to Prevent PTSD', 'orgStudyIdInfo': {'id': 'IRB00063758'}, 'secondaryIdInfos': [{'id': 'NARSAD 19798', 'type': 'OTHER', 'domain': 'Other'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Assessment only', 'description': 'Participants will receive assessment only.'}, {'type': 'EXPERIMENTAL', 'label': '1-session exposure intervention', 'description': 'Participants will receive one session of exposure therapy.', 'interventionNames': ['Behavioral: 1-Session Exposure Therapy']}, {'type': 'EXPERIMENTAL', 'label': '3-session exposure intervention', 'description': 'Participants will receive three sessions of exposure therapy.', 'interventionNames': ['Behavioral: 3-Session Exposure Therapy']}], 'interventions': [{'name': '1-Session Exposure Therapy', 'type': 'BEHAVIORAL', 'description': 'One exposure therapy session lasting one hour', 'armGroupLabels': ['1-session exposure intervention']}, {'name': '3-Session Exposure Therapy', 'type': 'BEHAVIORAL', 'description': 'Three exposure therapy sessions lasting one hour each, delivered one week apart', 'armGroupLabels': ['3-session exposure intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital, Emergency Department', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Barbara O. Rothbaum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Psychiatry and Associate Vice Chair of Clinical Research', 'investigatorFullName': 'Barbara O. Rothbaum, PhD', 'investigatorAffiliation': 'Emory University'}}}}