Viewing Study NCT05309005


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Study NCT ID: NCT05309005
Status: UNKNOWN
Last Update Posted: 2022-11-10
First Post: 2022-03-24
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Virtual Reality and Social Cognition After Acquired Brain Injury
Sponsor: Sunnaas Rehabilitation Hospital
Organization:

Study Overview

Official Title: Virtual Reality and Social Cognition After Acquired Brain Injury
Status: UNKNOWN
Status Verified Date: 2022-11
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The study aim is to improve assessment and understanding of social cognitive impairment after acquired brain injury by developing and validating a virtual reality version of The Awareness of Social Inference Test (TASIT). It is expected that the VR version of the test has comparable or better psychometric properties than the video version, and that it has improved relevance to everyday social skills. It is also expected that the VR version taxes cognitive functions more than a desktop version with identical content as the VR version.
Detailed Description: The study's main aim is to validate a Norwegian virtual reality (VR) adaptation of The Awareness of Social Inference Test (TASIT) in an acquired brain injury population (ABI). The secondary aim is to increase our understanding of the interplay between social cognition and general cognition in a realistic social setting, i.e. an immersive virtual environment.

TASIT is one of the few available standardized tests of social cognition with good and documented norms and psychometric properties. The original TASIT consists of three subtests, one subtest measuring emotion recognition and two subtests measuring Theory of Mind. It has an A and a B form for retest purposes. Each subtest consists of short videos depicting various social scenes. The participant's task is to identify a character's emotions, beliefs or intentions, depending on the subtest. TASIT predicts social cognitive impairments in several patient groups, including ABI.

VR is an immersive, computer-generated three-dimensional environment. Computer- and behavioral interfaces are used to simulate the behavior of 3D entities that interact in real time with a user who is immersed in the virtual environment. VR facilitates a sense of social presence, i.e. a feeling of being part of social situations, not attainable in a two-dimensional medium. Assessing social cognition in a virtual environment with higher social presence could increase the test's ecological validity.

For the Norwegian version of TASIT the manuscripts from all videos from the A form were translated into Norwegian. The original dialogues and plot lines from the original test were retained, except minor adaptations for modernization purposes and to exploit the potential for social presence in VR. The scenes were filmed with a 360-degree camera, allowing production of one immersive three-dimensional VR version (VR TASIT) and a standard, two-dimensional desktop version (DT TASIT). The versions are otherwise identical.

Research Questions: The overall aim is to improve assessment and understanding of social cognitive impairment in patients with ABI. This will be done by investigating the psychometric properties and validity of a VR version of TASIT.

The primary research question is:

1. What is the construct validity (known groups validity, convergent and divergent validity) and test-retest reliability of a Norwegian VR version of TASIT (VR TASIT), and are the psychometric properties comparable or improved compared to the original test?

Secondary research questions are:
2. Does the VR version of TASIT contribute to increased ecological validity in assessment of social cognition?
3. Does the application of VR TASIT result in increased cognitive load compared to the 2D version, and thus in higher correlations with tests of processing speed, attention, abstract thinking and executive functioning?

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: