ISRCTN81350364
Completed
未知
The effectiveness of the Treatment op Social cognition and Emotion regulation (T-ScEmo) compared to training of attention (CogniPlus) on social functioning (i.e. social cognition performances, behavioral complaints, participation and quality of life) after moderate to severe traumatic brain injury: a randomized controlled trial
Hersenstichting Nederland (Dutch Brain Foundation)0 sites61 target enrollmentOctober 21, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hersenstichting Nederland (Dutch Brain Foundation)
- Enrollment
- 61
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2017 results in https://pubmed.ncbi.nlm.nih.gov/28786854/ (added 27/11/2020)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Moderate to severe traumatic brain injury
- •2\. Sub\-acute or chronic stage of recovery
- •3\. Referred on clinical grounds, that is, being identified as having changes in social functioning, with at least 1 deficit in social cognition tests and/or proxy ratings on the BAFQ\-social monitoring and/or empathy scale\>10
- •4\. Orbitofrontal/medioprefrontal brain damage demonstrated with MRI
- •5\. Presence of a proxy to fill in questionnaires
Exclusion Criteria
- •1\. Neurodegenerative or psychiatric illness
- •2\. Severe cognitive impairment that would preclude treatment (i.e. amnestic syndrome, global aphasia, neglect)
- •3\. Very severe behavioral regulation deficits for which continuous external control was needed and/or physical aggressiveness
- •4\. Severe depression
Outcomes
Primary Outcomes
Not specified
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