Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:32 PM
Study NCT ID:
NCT01564667
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2012-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-13', 'studyFirstSubmitDate': '2012-03-26', 'studyFirstSubmitQcDate': '2012-03-27', 'lastUpdatePostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Will Posttraumatic Stress Disorder and Symptom decrease with intervention', 'timeFrame': '8 weeks', 'description': 'Using Clinician-Administered PTSD Scale (CAPS): 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) to assess symptoms of PTSD outcome.'}], 'secondaryOutcomes': [{'measure': 'Other psychiatics symptoms (ie Depression, Anger, Anxiety)', 'timeFrame': '8 weeks', 'description': 'To assess potential decrease in psychiatric symptoms associated with PTSD, by comparing pre intervention and post intervention scores on psychological measures of deprssion, anger and anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD', 'Posttraumatic Stress', 'Post Traumatic Stress', 'Attention Bias', 'Threat Bias', 'Combat', 'Warzone'], 'conditions': ['Posttraumatic Stress Disorder']}, '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': 'Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a placebo control condition not designed to change attention patterns. Outcome measures will be PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological interviews and questionnaires. Participants will also be invited to participate in physiological testing before and after receiving AMBT or placebo to serve as additional outcome measures and assess brain functioning, heart rate, and muscle tension.\n\nThe investigators expect to see significant PTSD symptom reduction in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in which no symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective, we will offer active ABMT to those participants randomly assigned to the placebo arm if they would like to receive the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans with Posttraumatic Stress Disorder (PTSD) serving in United States Military after March 20, 2003.\n\nExclusion Criteria:\n\n* Schizophrenia\n* Bipolar Disorder\n* Obsessive Compulsive Disorder\n* Head Injury with Loss of Consciousness for more than 30 minutes\n* Active Alcohol/Substance Dependence in past 6 months'}, 'identificationModule': {'nctId': 'NCT01564667', 'briefTitle': 'Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'Attention Bias Modification Treatment for Warzone-Related PTSD: A Randomized Clinical Trial Magnetoencephalography Study', 'orgStudyIdInfo': {'id': '11-16311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Attention Bias Modification Treatment', 'description': 'Attention bias modification training using a computerized spatial attention task (dot-probe) designed to alter threat-bias attention patterns away from threat.', 'interventionNames': ['Behavioral: Attention Bias Modification Training Protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attentional Control Training', 'description': 'Attention control training using a computerized spatial attention taks (dot-probe) counter balances training toward and away from threat.', 'interventionNames': ['Behavioral: Attention Bias Modification Training Protocol']}], 'interventions': [{'name': 'Attention Bias Modification Training Protocol', 'type': 'BEHAVIORAL', 'description': 'Attention Bias Modification computerized training sessions administered 2 times per week for 4 weeks making a total of 8 training sessions.', 'armGroupLabels': ['Attention Bias Modification Treatment', 'Attentional Control Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68178', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Amy S Badura Brack, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Creighton University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'collaborators': [{'name': 'At Ease USA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}