- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03450356
The German Version of the Awareness of Social Inference Test (TASIT)
August 11, 2020 updated by: University Hospital, Basel, Switzerland
The German Version of the Awareness of Social Inference Test: Development of a Short and Sensitive Version for Use in Clinical Populations
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
240
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Basel, Switzerland, 4044
- University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteers
Description
Inclusion Criteria:
- from the age of 35,
- at least 7 years of education
- understand German or Swiss German
- Subjective statement of good health
- Signed consent
Exclusion Criteria:
- Montreal Cognitive Assessment (MoCA) value below the fifth percentile of subjectively cognitive healthy persons
- signs of depressive mood (Geriatric Depression Scale (GDS) score ≥ 5 points or Beck Depression Inventory (BDI) ≥ 10 points)
- Severe sensory deficits with potentially negative influence test results
- Severe motor deficits with potentially negative influence test results
- Systemic diseases or brain diseases with potentially negative Influence on test results
- St. n. Traumatic brain injury (with unconsciousness of at least 30 minutes)
- Severe pain with potentially negative influence on the test results
- Psychiatric problems like alcohol dependence syndrome or Schizophrenia according to Diagnostic and Statistical Manual (DSM)®-5
- Regular use of drugs with potentially negative Influence on the test results with the exception of taking Benzodiazepines at night
- general anesthesia less than 3 months ago
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy rate in emotion perception and perception of beliefs and intentions
Time Frame: 60 minutes
|
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.
|
60 minutes
|
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Accuracy rate in perception of beliefs
Time Frame: 60 minutes
|
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.
|
60 minutes
|
|
Accuracy rate in perception of intentions
Time Frame: 60 minutes
|
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.
|
60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marc Sollberger, PD Dr., University Hospital, Basel, Switzerland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2018
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
March 31, 2020
Study Registration Dates
First Submitted
February 23, 2018
First Submitted That Met QC Criteria
February 23, 2018
First Posted (Actual)
March 1, 2018
Study Record Updates
Last Update Posted (Actual)
August 12, 2020
Last Update Submitted That Met QC Criteria
August 11, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2017-01193; me15Sollberger
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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