Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT01466751
Status:
COMPLETED
Last Update Posted:
2019-06-20
First Post:
2011-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amitetkin@stanford.edu', 'phone': '650-725-5736', 'title': 'Amit Etkin', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Engaging Computerized Tasks', 'description': "Participants will log into a personalized website and engage in computerized tasks online.\n\nComputerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer.", 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Neurobehavioral Computerized Tasks', 'description': "Participants will log into a personalized website and engage in computerized tasks online.\n\nComputerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer.", 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reaction Time to Facial Affect Identification During Emotional Conflict', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaging Computerized Tasks', 'description': "Participants will log into a personalized website and engage in computerized tasks online.\n\nComputerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."}, {'id': 'OG001', 'title': 'Neurobehavioral Computerized Tasks', 'description': "Participants will log into a personalized website and engage in computerized tasks online.\n\nComputerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."}], 'classes': [{'title': 'Baseline Congruent Fear', 'categories': [{'measurements': [{'value': '802.15', 'spread': '155.14', 'groupId': 'OG000'}, {'value': '889.14', 'spread': '135.65', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Incongruent Fear', 'categories': [{'measurements': [{'value': '848.79', 'spread': '142.18', 'groupId': 'OG000'}, {'value': '937.97', 'spread': '151.94', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Congruent Happy', 'categories': [{'measurements': [{'value': '764.08', 'spread': '130.52', 'groupId': 'OG000'}, {'value': '868.45', 'spread': '131.05', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Incongruent Happy', 'categories': [{'measurements': [{'value': '830.06', 'spread': '142.29', 'groupId': 'OG000'}, {'value': '961.49', 'spread': '134.32', 'groupId': 'OG001'}]}]}, {'title': '3 Month Congruent Fear', 'categories': [{'measurements': [{'value': '814.58', 'spread': '158.56', 'groupId': 'OG000'}, {'value': '872.84', 'spread': '178.04', 'groupId': 'OG001'}]}]}, {'title': '3 Month Incongruent Fear', 'categories': [{'measurements': [{'value': '863.80', 'spread': '144.65', 'groupId': 'OG000'}, {'value': '909.89', 'spread': '193.45', 'groupId': 'OG001'}]}]}, {'title': '3 Month Congruent Happy', 'categories': [{'measurements': [{'value': '796.54', 'spread': '130.62', 'groupId': 'OG000'}, {'value': '824.36', 'spread': '196.77', 'groupId': 'OG001'}]}]}, {'title': '3 Month Incongruent Happy', 'categories': [{'measurements': [{'value': '878.40', 'spread': '175.54', 'groupId': 'OG000'}, {'value': '890.90', 'spread': '196.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Type III Tests of Fixed Effects', 'ciNumSides': 'TWO_SIDED', 'paramValue': '8.687', 'pValueComment': 'A-priori threshold for statistical significance: p \\< 0.05. No correction for multiple comparisons. The omnibus effect from the linear mixed model for the Treatment Arm x Time Interaction was utilized to establish significance of the effect.', 'groupDescription': 'A linear mixed model was utilized to test the null hypothesis that the intervention groups would show equivalent performance change on the outcome measure from baseline to the 3 month time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Numerator degrees of freedom=1, Denominator degrees of freedom = 168'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month', 'description': 'A standardized set of facial emotions (fear and happy) were presented for a duration of about 1 second in quick succession (a new face every 3-5 seconds). Across each face was written an emotional word ("FEAR" or "HAPPY"), which could be either congruent or incongruent with the facial expression. The participant was instructed to identify the facial emotion as quickly as possible and ignore the overlaid emotion word. The outcome measure of interest was the average speed (across all trials presented) within which an individual could correctly identify the facial emotion as a function of time (pre or post-intervention), treatment arm (control or intervention), facial affect (fear or happy), and congruency of word and facial affect (congruent or incongruent).', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who complete the protocol were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurobehavioral Computerized Tasks', 'description': "Participants will log into a personalized website and engage in computerized tasks online.\n\nComputerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."}, {'id': 'OG001', 'title': 'Engaging Computerized Tasks', 'description': "Participants will log into a personalized website and engage in computerized tasks online.\n\nComputerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."}], 'classes': [{'title': 'Baseline Left Amygdala Fear', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Left Amygdala Happy', 'categories': [{'measurements': [{'value': '0.25', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Right Amygdala Fear', 'categories': [{'measurements': [{'value': '0.04', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Right Amygdala Happy', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': '3 Month Left Amygdala Fear', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': '3 Month Left Amygdala Happy', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': '3 Month Right Amygdala Fear', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': '3 Month Right Amygdala Happy', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.156', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Type III Tests of Fixed Effects', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.032', 'pValueComment': 'No adjustment for multiple comparisons. The a priori threshold was: p \\< 0.05.', 'groupDescription': 'A linear mixed model was used to test the null hypothesis that the two treatment groups would display no differential changes in amygdala BOLD signal from baseline to 3 months as a main effect or in interaction with facial affect type (fear or happy) or by brain hemisphere (left or right).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Numerator degrees of freedom: 1, Denominator degrees of freedom: 168'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 Months', 'description': 'The degree of differential BOLD signal change (T2\\*-weighted contrast in a defined region of the brain as measured by functional magnetic resonance imaging) within each individual, averaged across trials, during facial affect identification (fear or happy) and induction of emotional conflict (when the emotion word "FEAR" or "HAPPY" was either congruent or incongruent with the facial expression). We examined the differential degree of amygdala BOLD signal change as a function of emotion type (fear or happy), congruency (congruent or incongruent), and hemisphere (left or right) at baseline and 3 months.', 'unitOfMeasure': 'Percentage of BOLD signal change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neurobehavioral Computerized Tasks', 'description': "Participants will log into a personalized website and engage in computerized tasks online.\n\nComputerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."}, {'id': 'FG001', 'title': 'Engaging Computerized Tasks', 'description': "Participants will log into a personalized website and engage in computerized tasks online.\n\nComputerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Engaging Computerized Tasks', 'description': "Participants will log into a personalized website and engage in computerized tasks online.\n\nComputerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."}, {'id': 'BG001', 'title': 'Neurobehavioral Computerized Tasks', 'description': "Participants will log into a personalized website and engage in computerized tasks online.\n\nComputerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '10', 'groupId': 'BG000'}, {'value': '36', 'spread': '12', 'groupId': 'BG001'}, {'value': '35.5', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-22', 'studyFirstSubmitDate': '2011-11-03', 'resultsFirstSubmitDate': '2015-07-15', 'studyFirstSubmitQcDate': '2011-11-07', 'lastUpdatePostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-22', 'studyFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reaction Time to Facial Affect Identification During Emotional Conflict', 'timeFrame': 'Baseline, 3-month', 'description': 'A standardized set of facial emotions (fear and happy) were presented for a duration of about 1 second in quick succession (a new face every 3-5 seconds). Across each face was written an emotional word ("FEAR" or "HAPPY"), which could be either congruent or incongruent with the facial expression. The participant was instructed to identify the facial emotion as quickly as possible and ignore the overlaid emotion word. The outcome measure of interest was the average speed (across all trials presented) within which an individual could correctly identify the facial emotion as a function of time (pre or post-intervention), treatment arm (control or intervention), facial affect (fear or happy), and congruency of word and facial affect (congruent or incongruent).'}, {'measure': 'Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict', 'timeFrame': 'Baseline, 3 Months', 'description': 'The degree of differential BOLD signal change (T2\\*-weighted contrast in a defined region of the brain as measured by functional magnetic resonance imaging) within each individual, averaged across trials, during facial affect identification (fear or happy) and induction of emotional conflict (when the emotion word "FEAR" or "HAPPY" was either congruent or incongruent with the facial expression). We examined the differential degree of amygdala BOLD signal change as a function of emotion type (fear or happy), congruency (congruent or incongruent), and hemisphere (left or right) at baseline and 3 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Computerized neurobehavioral intervention'], 'conditions': ['Anxiety', 'Depression']}, 'descriptionModule': {'briefSummary': 'The present study will explore the effectiveness of a computer based neurobehavioral intervention in alleviating symptoms and improving emotion regulation in psychiatric populations. It will increase understanding of psychopathology at a neural-circuit level and aid development of new non-pharmacological treatment for emotion regulatory deficits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* current anxiety or depression symptoms\n* internet access\n\nExclusion Criteria:\n\n* lifetime psychotic disorder, past-year substance dependence'}, 'identificationModule': {'nctId': 'NCT01466751', 'briefTitle': 'Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits', 'orgStudyIdInfo': {'id': 'IRB-19338'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Engaging computerized tasks', 'description': 'Participants will log into a personalized website and engage in computerized tasks online.', 'interventionNames': ['Behavioral: Computerized Neurobehavioral Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Neurobehavioral computerized tasks', 'description': 'Participants will log into a personalized website and engage in computerized tasks online.', 'interventionNames': ['Behavioral: Computerized Neurobehavioral Intervention']}], 'interventions': [{'name': 'Computerized Neurobehavioral Intervention', 'type': 'BEHAVIORAL', 'description': "Targeted, computerized interventions completed from the participants' own home on a computer.", 'armGroupLabels': ['Engaging computerized tasks', 'Neurobehavioral computerized tasks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University, Department of Psychiatry and Behavioral Sciences', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Greg Fonzo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Amit Etkin', 'investigatorAffiliation': 'Stanford University'}}}}