Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-01-28 @ 8:39 PM
Study NCT ID:
NCT03271359
Status:
UNKNOWN
Last Update Posted:
2017-09-07
First Post:
2017-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EMDR vs. PC For Motor Vehicle Accident Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067073', 'term': 'Psychological Trauma'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057169', 'term': 'Eye Movement Desensitization Reprocessing'}], 'ancestors': [{'id': 'D003887', 'term': 'Desensitization, Psychologic'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-04', 'studyFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in SUDS following treatment', 'timeFrame': 'Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment', 'description': 'Subjective Units of Distress Scale'}, {'measure': 'Change in PRS following treatment', 'timeFrame': 'Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment', 'description': 'Problem Rating Scale'}, {'measure': 'Change in PDS following treatment', 'timeFrame': 'Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment', 'description': 'PTSD Diagnostic Scale'}]}, 'conditionsModule': {'conditions': ['Trauma, Psychological', 'Motor Vehicle Accident']}, 'descriptionModule': {'briefSummary': 'This is a randomized clinical trial comparing eye movement desensitization and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who are distressed by the memory of a motor vehicle accident. Participants will be assigned to the geographically nearest therapist, and then randomized to treatment condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult reporting distress related to motor vehicle accident-related trauma\n* English-speaking\n\nExclusion Criteria:\n\n* already in therapy in which the memory of interest is being actively addressed with a structured/focused trauma resolution method\n* any obvious/urgent need for more comprehensive psychotherapy (based on initial screening interview)\n* any indication of instability during interactions prior to the therapy session\n* an average score on the Dissociative Experiences Scale of 30 or greater, if (as per follow-up questions) indicating a likely dissociative disorder'}, 'identificationModule': {'nctId': 'NCT03271359', 'briefTitle': 'EMDR vs. PC For Motor Vehicle Accident Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Trauma Institute & Child Trauma Institute'}, 'officialTitle': 'EMDR vs. PC For Motor Vehicle Accident Trauma', 'orgStudyIdInfo': {'id': '2015-GRE-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eye movement desensitization and reprocessing (EMDR) arm', 'interventionNames': ['Behavioral: EMDR']}, {'type': 'EXPERIMENTAL', 'label': 'Progressive counting (PC) arm', 'interventionNames': ['Behavioral: PC']}], 'interventions': [{'name': 'EMDR', 'type': 'BEHAVIORAL', 'description': 'Initial EMDR session of up to three hours; about one week later, follow-up session of up to one hour', 'armGroupLabels': ['Eye movement desensitization and reprocessing (EMDR) arm']}, {'name': 'PC', 'type': 'BEHAVIORAL', 'description': 'Initial PC session of up to three hours; about one week later, follow-up session of up to one hour', 'armGroupLabels': ['Progressive counting (PC) arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01060', 'city': 'Northampton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Trauma Institute & Child Trauma Institute', 'geoPoint': {'lat': 42.32509, 'lon': -72.6412}}], 'overallOfficials': [{'name': 'Ricky Greenwald', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trauma Institute & Child Trauma Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trauma Institute & Child Trauma Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}