Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT04290234
Status:
UNKNOWN
Last Update Posted:
2020-02-28
First Post:
2020-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Childhood Trauma and Escape Decision Dynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-26', 'studyFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2020-02-26', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neural responses in the flight initiation distance (FID) task', 'timeFrame': 'fMRI paradigm with an average duration of 45 minutes', 'description': 'Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in a flight initiation distance (FID) task, involving fast-, medium- and slow-attacking virtual predators that elicit distinct activations in the reactive and cognitive fear circuits. Blood-oxygen-level-dependent signals to different predator velocities will be analyzed. Analyses will focus on regions-of-interest associated with the processing of cognitive fear (ventromedial prefrontal cortex, posterior cingulate cortex, hippocampus, and basolateral amygdala) and reactive fear (midbrain periaqueductal gray, central amygdala, hypothalamus, and the midcingulate cortex). To examine effects of childhood maltreatment, regression analyses with Childhood Trauma Questionnaire scores will be conducted on the second level.'}, {'measure': 'Flight distance in the flight initiation distance (FID) task', 'timeFrame': 'fMRI paradigm with an average duration of 45 minutes', 'description': 'Associations between the flight distance in the FID task and childhood maltreatment will be analyzed using regression analyses with Childhood Trauma Questionnaire scores. Behavioral data will be correlated with fMRI data of the FID task.'}, {'measure': 'Difficulty ratings in the flight initiation distance (FID) task', 'timeFrame': 'fMRI paradigm with an average duration of 45 minutes', 'description': 'Associations between the difficulty ratings in the FID task and childhood maltreatment will be analyzed using regression analyses with Childhood Trauma Questionnaire scores. Behavioral data will be correlated with fMRI data of the FID task.'}, {'measure': 'Confidence ratings in the flight initiation distance (FID) task', 'timeFrame': 'fMRI paradigm with an average duration of 45 minutes', 'description': 'Associations between the confidence ratings in the FID task and childhood maltreatment will be analyzed using regression analyses with Childhood Trauma Questionnaire scores. Behavioral data will be correlated with fMRI data of the FID task.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive fear', 'fMRI', 'reactive fear'], 'conditions': ['Child Abuse', 'Fear']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of childhood maltreatment on cognitive and reactive fear.', 'detailedDescription': 'Childhood maltreatment dramatically increases the risk for psychiatric disorders accompanied by profound difficulties in social interactions. However, it is still unclear how childhood maltreatment affects social interactions in adulthood. In this study, we examine how childhood maltreatment may modulate threat sensitivity assessed by the distance at which an individual flees from an approaching threat. While rapid escape decisions rely on "reactive fear" circuits, slower escape decisions are associated with "cognitive fear" circuits. Based on previous observations of altered early sensory processing, we expect that childhood maltreatment affects both cognitive and reactive fear circuits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from a community sample and childhood maltreatment will be assessed with the Childhood Trauma Questionnaire.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects with varying levels of childhood maltreatment\n\nExclusion Criteria:\n\n* current psychiatric illness\n* current psychiatric medication or psychotherapy\n* MRI contraindication (e.g. metal in body, claustrophobia)\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04290234', 'acronym': 'TEDDY', 'briefTitle': 'Childhood Trauma and Escape Decision Dynamics', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'The Influence of Childhood Maltreatment on Cognitive and Reactive Fear', 'orgStudyIdInfo': {'id': 'TEDDY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-medicated healthy adults with childhood maltreatment', 'description': 'The 25-item retrospective Childhood Trauma Questionnaire (CTQ) will be administered to assess history of abuse and neglect. The CTQ measures five types of maltreatment: emotional, physical, and sexual abuse and emotional and physical neglect.', 'interventionNames': ['Other: fMRI assessment of cognitive and reactive fear']}], 'interventions': [{'name': 'fMRI assessment of cognitive and reactive fear', 'type': 'OTHER', 'description': 'An fMRI paradigm will be used to probe how childhood maltreatment may modulate the defensive survival circuitry that facilitates escape decisions when subjects encounter fast- or slow-attacking threats.', 'armGroupLabels': ['Non-medicated healthy adults with childhood maltreatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53105', 'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rene Hurlemann, MSc MD PhD', 'role': 'CONTACT', 'email': 'Rene.Hurlemann@ukbonn.de'}, {'name': 'Dirk Scheele, PhD', 'role': 'CONTACT', 'email': 'Dirk.Scheele@ukb.uni-bonn.de'}, {'name': 'Rene Hurlemann, MSc, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dirk Scheele, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Psychiatry, University of Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}], 'centralContacts': [{'name': 'Dirk Scheele, PhD', 'role': 'CONTACT', 'email': 'Dirk.Scheele@ukbonn.de', 'phone': '+49-(0)228-287', 'phoneExt': '11151'}], 'overallOfficials': [{'name': 'Dirk Scheele, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bonn'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prof. Dean Mobbs', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor for Psychiatry', 'investigatorFullName': 'Rene Hurlemann', 'investigatorAffiliation': 'University of Oldenburg'}}}}