To determine the feasibility and the estimation of the effect for the primary study parameter of a cognitive rehabilitation treatment for deficits in social cognition after traumatic brain injury.
ID
Source
Brief title
Condition
- Other condition
- Structural brain disorders
Synonym
Health condition
traumatisch hersenletsel; stoornissen in sociale cognitie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improvement of social cognition, that is, a significant difference between pre-
and postmeasurement on the The Awareness of Social Inference Test (TASIT, Mc
Donald, 2003).
Secondary outcome
Checklists and questionnaires for social functioning in daily life (KATZ
adjustmentscales,(KAS-R, Goran & Fabiano, 1993), Dysexecutive Questionnaire
(DEX, Wilson, e.a., 1996), NBAP, Nelson, 1998,, Quality of Life after Brain
Injury (QOLIBRI, Von Steinbuchel e.a., 2005). Tests for social cognition (FEEST
( Young e.a., 2002), Cartoon Test (Happe e.a. 1999), Faux Pas test (Stone
e.a., 1998), Sustained Attention to response Task (SART, Robertson e.a., 1997),
Iowa Gambling Task (Bechara e.a., 1994), Emotional Empathy Questionnaire (EEQ,
Mehrabian & Epstein,1972), Read the Mind in the Eyes (Baron-Cohen, e.a., 1997)
), for executive functioning (Behavioural Assessment of the Dysexecutive
Syndrome (BADS, Wilson et al, 1996)), and an estimation of premorbid IQ by
means of the Dutch version of the NART (NLV, Schmand e.a., 1992).
Background summary
Patients with traumatic brain injury (TBI) can have deficits in social
cognition because of damage to orbitofrontal/ventromedial prefrontal brain
area's. Social cognition is the ability to perceive social information (i.e.
emotional expressions on faces), to integrate this information with general
knowledge of social concepts and conventions in order to understand the
behaviour or others, and to adapt behaviour to the social situation. Deficits
in social cognition manifest themselves as socially inadequate, egocentrical,
disinhibited or emotionally indifferent behaviour. Such behavior has serious,
adverse consequences for the ability of patients to function adequately in
daily life situations, that is, to be involved in social relationships with
others and to maintain a job. There is much evidence that deficits in social
cognition, more than cognitive or physical consequences of brain injury, have a
negative influence on the outcome of patients. Until now there were no
adequate, multi-faceted treatment possibilties for these patients, although
sorely needed. There are soms studies in whcih single aspect treatment of
social cognition is described, but the majority of these concern other,
neuropsychiatric patient groups. Seldomly treatments are evaluated in the form
of an RCT. We developed a treatment protocol in wich all three aspects of
social cognition (perception, understanding and regulation of social
situations) are treated, in which successfull elements of other treatments are
incorporated and which has the explicit goal to improve social behaviour in
daily life.
Study objective
To determine the feasibility and the estimation of the effect for the primary
study parameter of a cognitive rehabilitation treatment for deficits in social
cognition after traumatic brain injury.
Study design
A pilotstudy with 8 TBI patients in a repeated measures design (pre- and
postmeasurement) on the effect of a cognitive rehabilitationtreatment for
deficits in social cognition after traumatic brain injury.
Intervention
A cognitive rehabiliation treatment of deficits in social cognition, given by
an experienced neuropsychologist, twice a week, 20-24 1hr sessions in total
Study burden and risks
There will be no adverse consequences of the treatment nor risks for the
patients involved. The burden is small and mainly psychological, that is, the
treatment will be rather intensive en requires patients to be motivated.
However, this will be carefully supervised and coached by the psychologist who
gives the treatment and who has ample experience with brain injured patients.
UMCG, Hanzeplein 1
9713 GZ Groningen
Nederland
UMCG, Hanzeplein 1
9713 GZ Groningen
Nederland
Listed location countries
Age
Inclusion criteria
1) deficient score on the Neuro Behavioural Affect Profile (NBAP, Nelson, 1998)
2) deficient score on the Facial Expression of Emotion TEst (FEEST, Young, 2003) AND/OR orbitofrontal/mediofrontal damage on MRI
Exclusion criteria
neurodegenerative or psychiatric disorders, lack of self-awareness (indicated by a difference score of 0 on the self-rating version of the NBAP between rating of premorbid and present functioning), severe cognitive comorbidity interfering with the ability to follow treatment (global aphasia, neglect, amnestic syndrome).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25269.042.08 |