To investigate the treatment effect of the protocol Treatment of deficits in Emotion, Social Cognition and behaviour regulation (T-ScEMO) after traumatic brain injury.
ID
Source
Brief title
Condition
- Other condition
- Structural brain disorders
Synonym
Health condition
traumatisch hersenletsel; stoornissen in de sociale cognitie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Inprovement of social cognition, that is, a significant improvement pre- to
postmeasurement on the Awareness of Social Inference Test (TASIT, Mc Donald et
al., 2003).
Secondary outcome
Questionnaires and checklist for social functioning in daily life (patient):
* Balanced Emotional Empathy Scale (BEES, Mehrabian,2000),
* Berkeley Expressivity Questionnaire (BEQ, Gross & John, 1997),
* Brock Adaptive Functioning Questionnaire (BAFQ, Dywan & Segalowitz, 1996),
* Dysexecutive Questionnaire (DEX, Wilson, e.a., 1996),
* Quality of Life after Brain Injury (QOLIBRI, Von Steinbuchel e.a., 2005),
* Self Efficacy for Symptom Management (SEsx, Cicerone, 2008),
* Treatment Goal Attainment (TGA, Spikman et al. 2010),
* Utrechtse Copinglijst (UCL, Schreurs & van de Willige, 1988).
Questionnaires and checklist for social functioning in daily life
(psychologist, psychological assistant, proxy):
* Brock Adaptive Functioning Questionnaire (BAFQ, Dywan & Segalowitz, 1996),
* Dysexecutive Questionnaire (DEX, Wilson, e.a., 1996),
* Rolhervattingslijst (RLL, Spikman et al., 2010),
* Proxy questionnaire (developed for this study, 2011).
Tests voor social cognition
* Facial Expression of Emotional Stimuli Test (FEEST (Young e.a., 2002),
* Cartoon Test (Happé e.a. 1999),
* Faux Pas test (Stone e.a., 1998),
* Iowa Gambling Task (IGT, Bechara e.a., 1994).
Cognitive functions:
* Premorbid IQ (Nederlandse Leestest voor Volwassenen, NLV, Schmand e.a.,
1992).
* Executive functioning (Zoomap, Behavioural Assessment of the Dysexecutive
Syndrome (BADS, Wilson et al, 1996)),
* Memory
-15 woordentest (15 woordentest, Deelman, Brouwer, van
Zomeren en Saan, 1980)
- WAIS Digit Span (WAIS Digit Span, Wechsler Adult
Intelligence Scale-III, Wechsler, 1997)
* Attention:
-Test of Everyday Attention (TEA, Robertson et al, 1994)
-Stroop Kleur Woord test (Stroop, 1935)
-Trailmaking test (TMT, Reitan, 1958)
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 expression of faces), to interpret this information of others and to
adapt behaviour to the social situation. Deficits in social cognition manifest
themselves as socially inadequate behaviour, egocentrical, disinhibited er
emotionally indifferent behaviour. Such behaviour has serious, adverse
consequences for the ability of patients to maintain social relationships with
others, to maintain a job and function in society. There is much evidence that
these deficits, more than the fysical or cognitive consequences of brain
injury, have a negative influence on the outcome of patients. Until now there
are no adequate, multi-faceted treatment possibilities for these patients,
although sorely needed. There are some studies which focus on aspects of social
cognition, mostly in neuropsychiatric patient groups. Seldomly are these
treatments evaluated in the form of an RCT, however. We developed a treatment
protocol which addresses all three aspects of social cognition (perception,
understanding of and regulation of behaviour), based on succesful elements of
other existing treatments.
Study objective
To investigate the treatment effect of the protocol Treatment of deficits in
Emotion, Social Cognition and behaviour regulation (T-ScEMO) after traumatic
brain injury.
Study design
A RCT in which the effectiveness of the treatment protocol social cognition is
compared with the training of attention.
Intervention
A cognitive rehabilitation treatment of deficits in social cognition, or a
training of attention, given by an experienced neuropsychologist, twice a week,
20 sessions of 1 hour each.
Study burden and risks
There will be no adverse consequences of the treatment a no risk for the
patients involved. The burden is small and mainly psychological, that is, the
treatment will be intensive and requires the 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
NL
UMCG, Hanzeplein 1
9713 GZ Groningen
NL
Listed location countries
Age
Inclusion criteria
1) Deficient score on the Brock Adaptive Functioning Questionnaire (BAFQ, Dywan & Segalowitz, 1996)
2) Deficient score on the Facial Expression of Emotion Test (FEEST, Young, 2003) AND/OR
3) orbitofrontal/mediofrontal damage on MRI
Exclusion criteria
Neurodegenerative or psychiatric disorders, lack of self-awareness, severe cognitive comorbidity interfering the ability to follow a treatment (global aphasia, neglect, amnestic symdrome), there is no proxy who can fill in the questionnaires. See page 15 and 16 of the protocol
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 | NL36391.042.11 |