Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT03450356
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2018-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The German Version of the Awareness of Social Inference Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2018-02-23', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy rate in emotion perception and perception of beliefs and intentions', 'timeFrame': '60 minutes', 'description': 'The proportion of top scorers for any question - i.e. the proportion of participants who reach the full score of a specific scene. This proportion will be estimated for each scene and intensity separately with 95% confidence interval.'}, {'measure': 'Accuracy rate in perception of beliefs', 'timeFrame': '60 minutes', 'description': 'The proportion of top scorers for any question - i.e. the proportion of participants who reach the full score of a specific scene. This proportion will be estimated for each scene and intensity separately with 95% confidence interval.'}, {'measure': 'Accuracy rate in perception of intentions', 'timeFrame': '60 minutes', 'description': 'The proportion of top scorers for any question - i.e. the proportion of participants who reach the full score of a specific scene. This proportion will be estimated for each scene and intensity separately with 95% confidence interval.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Social Cognition']}, 'descriptionModule': {'briefSummary': 'Goal of the current project is the development of a German-language test battery for a realistic investigation of core areas of social issues Cognition (emotion, perspective taking). This test battery should be used in the investigation of patients with neuropsychological disorders. Investigators plan to establish a German-version of the TASIT that is more sensitive and shorter in administration than the original TASIT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* from the age of 35,\n* at least 7 years of education\n* understand German or Swiss German\n* Subjective statement of good health\n* Signed consent\n\nExclusion Criteria:\n\n* Montreal Cognitive Assessment (MoCA) value below the fifth percentile of subjectively cognitive healthy persons\n* signs of depressive mood (Geriatric Depression Scale (GDS) score ≥ 5 points or Beck Depression Inventory (BDI) ≥ 10 points)\n* Severe sensory deficits with potentially negative influence test results\n* Severe motor deficits with potentially negative influence test results\n* Systemic diseases or brain diseases with potentially negative Influence on test results\n* St. n. Traumatic brain injury (with unconsciousness of at least 30 minutes)\n* Severe pain with potentially negative influence on the test results\n* Psychiatric problems like alcohol dependence syndrome or Schizophrenia according to Diagnostic and Statistical Manual (DSM)®-5\n* Regular use of drugs with potentially negative Influence on the test results with the exception of taking Benzodiazepines at night\n* general anesthesia less than 3 months ago'}, 'identificationModule': {'nctId': 'NCT03450356', 'acronym': 'TASIT', 'briefTitle': 'The German Version of the Awareness of Social Inference Test', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'The German Version of the Awareness of Social Inference Test: Development of a Short and Sensitive Version for Use in Clinical Populations', 'orgStudyIdInfo': {'id': '2017-01193; me15Sollberger'}}, 'contactsLocationsModule': {'locations': [{'zip': '4044', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Marc Sollberger, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}