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Clinical Trials/ISRCTN81350364
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)

Registry
who.int
Start Date
October 21, 2016
End Date
December 31, 2016
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hersenstichting Nederland (Dutch Brain Foundation)

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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