Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT01368302
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2011-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Attention Bias Modification Treatment (ABMT) for Patients With Post Traumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-06', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician-Administered PTSD Scale (CAPS)', 'timeFrame': '40 minutes', 'description': 'The clinician-Administered PTSD Scale (CAPS) is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD (Blake, Weathers, Nagy, Kaloupek, Charney, \\& Keane, 1995).'}], 'secondaryOutcomes': [{'measure': 'PTSD Check List (PCL)', 'timeFrame': '10 minutes', 'description': 'Post-traumatic Stress symptoms will be evaluated using the 17-item National Center for PTSD Checklist of the Department of Veterans Affairs- PCL (Blanchard, Jones-Alexander, Buckley, \\& Forneris, 1996; Hoge, 2004; Kang, Natelson, Mahan, Lee, \\& Murphy, 2003).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['attention bias modification treatment', 'cognitive bias modification', 'attention training', 'anxiety'], 'conditions': ['Attention Bias Modification Treatment (ABMT)']}, 'referencesModule': {'references': [{'pmid': '20887977', 'type': 'BACKGROUND', 'citation': 'Hakamata Y, Lissek S, Bar-Haim Y, Britton JC, Fox NA, Leibenluft E, Ernst M, Pine DS. Attention bias modification treatment: a meta-analysis toward the establishment of novel treatment for anxiety. Biol Psychiatry. 2010 Dec 1;68(11):982-90. doi: 10.1016/j.biopsych.2010.07.021.'}, {'pmid': '26206075', 'type': 'DERIVED', 'citation': 'Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'Patients with Post Traumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to normalize threat-related attention biases or a placebo control condition not designed to change attention patterns. Outcome measures will be Post Traumatic Stress Disorder (PTSD), depression, and anxiety symptoms as measured by gold standard questionnaires and symptom counts derived from structured clinical interviews.\n\nWe expect to see significant Post Traumatic Stress Disorder symptom reduction in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in which no symptomatic relief is expected.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Combat-related PTSD diagnosis\n\nExclusion Criteria:\n\n* Other treatment'}, 'identificationModule': {'nctId': 'NCT01368302', 'briefTitle': 'Attention Bias Modification Treatment (ABMT) for Patients With Post Traumatic Stress Disorder (PTSD)', 'organization': {'class': 'OTHER', 'fullName': 'Tel Aviv University'}, 'officialTitle': 'Attention Bias Modification Treatment (ABMT) for Patients With Post Traumatic Stress Disorder (PTSD)', 'orgStudyIdInfo': {'id': '949-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Attention Bias Modification (ABM)', 'description': 'Attention training via repeated trials of a dot-probe task intended to normalize threat-related attention biases.', 'interventionNames': ['Behavioral: Attention Bias Modification Treatment (ABMT)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns.', 'interventionNames': ['Behavioral: Attention Bias Modification Treatment (ABMT)']}], 'interventions': [{'name': 'Attention Bias Modification Treatment (ABMT)', 'type': 'BEHAVIORAL', 'description': 'Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.', 'armGroupLabels': ['Attention Bias Modification (ABM)', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69978', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv University', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel Aviv University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yair Bar-Haim', 'investigatorAffiliation': 'Tel Aviv University'}}}}