Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-04 @ 8:13 PM
Study NCT ID:
NCT00474305
Status:
UNKNOWN
Last Update Posted:
2010-12-16
First Post:
2007-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Prolonged Exposure (PE) for Bus Bomb Survivors
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-15', 'studyFirstSubmitDate': '2007-05-15', 'studyFirstSubmitQcDate': '2007-05-15', 'lastUpdatePostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician Administered PTSD Scale (CAPS)', 'timeFrame': 'Pre and Post Treatment'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory', 'timeFrame': 'Pre and Post Treatment'}, {'measure': 'Activity Card Sort', 'timeFrame': 'Pre and Post Treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PTSD', 'Prolonged Exposure', 'Virtual Reality'], 'conditions': ['PTSD']}, 'referencesModule': {'references': [{'pmid': '16891607', 'type': 'BACKGROUND', 'citation': 'Difede J, Cukor J, Patt I, Giosan C, Hoffman H. The application of virtual reality to the treatment of PTSD following the WTC attack. Ann N Y Acad Sci. 2006 Jul;1071:500-1. doi: 10.1196/annals.1364.052.'}, {'pmid': '20528299', 'type': 'DERIVED', 'citation': 'Freedman SA, Hoffman HG, Garcia-Palacios A, Tamar Weiss PL, Avitzour S, Josman N. Prolonged exposure and virtual reality-enhanced imaginal exposure for PTSD following a terrorist bulldozer attack: a case study. Cyberpsychol Behav Soc Netw. 2010 Feb;13(1):95-101. doi: 10.1089/cyber.2009.0271.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine whether the use of a Virtual World will be effective in helping treat Posttraumatic Stress Disorder (PTSD). This is a pilot study, with five victims of bus bombings who have developed PTSD. The study will examine pre- and post-treatment levels of PTSD, anxiety, depression and day-to-day functioning.', 'detailedDescription': 'PTSD can be a long-term debilitating psychiatric problem, occurring following exposure to a traumatic event. Recent studies have shown that Cognitive Behavioral Therapy is effective in the treatment of PTSD. More specifically, a protocol called Prolonged Exposure, where the patient is gradually exposed to feared stimuli, along with building a narrative of the traumatic event, has been shown to reduce PTSD and depression symptoms, both at the end of therapy (9-12 weeks) and at long term follow up.\n\nDespite this success, some patients do not show symptom reduction with this therapy. Virtual Reality, where a real-time virtual world is created, has been successfully used to treat a variety of fears, from pain management to fear of flying. This technique has also been successfully used with patients who have not benefited from Prolonged Exposure for their PTSD, following 9/11.\n\nThis study will examine the use of a virtual reality world that involves a bus bombing. It has been created using different levels of exposure to distressing detail, such that the therapist can control the amount of exposure. The protocol is based on Prolonged Exposure, with the Virtual Reality being used to help the patient build a narrative of the event.\n\nFive patients with PTSD following a bus bombing will be treated. They will be assessed pre and post-treatment for symptoms levels of PTSD, depression, anxiety and daily functioning. The treatment consists of 9 sessions, each lasting 90 minutes. Therapy will be supervised, and protocol adherence will be checked by an external therapist. All therapists are trained as supervisors in Prolonged Exposure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PTSD following a bus bombing\n* Hebrew speaking\n\nExclusion Criteria:\n\n* Other psychiatric illness\n* Other concurrent intervention'}, 'identificationModule': {'nctId': 'NCT00474305', 'briefTitle': 'Virtual Reality Prolonged Exposure (PE) for Bus Bomb Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Effectiveness of Virtual Reality for Persons With PTSD Following a Bus Bombing', 'orgStudyIdInfo': {'id': 'VR-PTSD-HMO-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Virtual Reality Treatment for PTSD', 'type': 'BEHAVIORAL', 'description': '12 session protocol for Prolonged Exposure with Virtual Reality. All sessions 90 minutes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sara A Freedman, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Rena Cooper Kazaz, MD', 'role': 'CONTACT', 'phone': '97226777348'}, {'name': 'Hadas Lemberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '97226777572'}], 'overallOfficials': [{'name': 'Sara A Freedman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Haifa', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr Rena Cooper', 'oldOrganization': 'Hadassah Medical Organization'}}}}