Social CognitionTASITNCT03450356
The German Version of the Awareness of Social Inference Test
An observational study of Social Cognition, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Cognition
- How many people
- 240 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jan 2018to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- from the age of 35,
- at least 7 years of education
- understand German or Swiss German
- Subjective statement of good health
- Signed consent
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Social Cognition
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy rate in emotion perception and perception of beliefs and intentions
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.
Measured: 60 minutes
Accuracy rate in perception of beliefs
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.
Measured: 60 minutes
Accuracy rate in perception of intentions
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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start2 Jan 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social CognitionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Sollberger, PD Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450356
- Sponsor's protocol ID
- 2017-01193; me15Sollberger
- Other IDs
- 2017
- Acronym
- TASIT
- Status last verified
- Aug 2020
- First submitted
- 23 Feb 2018
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The German Version of the Awareness of Social Inference Test: Development of a Short and Sensitive Version for Use in Clinical Populations
- ClinicalTrials.gov ID
- NCT03450356
- Acronym / sponsor ID
- TASIT / 2017-01193; me15Sollberger
- Conditions
- Social Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (5 listed)
- from the age of 35,
- at least 7 years of education
- understand German or Swiss German
- Subjective statement of good health
- Signed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Sollberger, PD Dr. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Social Cognition, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy rate in emotion perception and perception of beliefs and intentions (time frame: 60 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.