Improving social cognition and social behaviour in various brain disorders
- Conditions
- eurologische aandoening, waaronder cva, ms, hersentumorenbrain tumorse.g. strokemsNeurological disorders
- Registration Number
- NL-OMON50821
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 92
Patients should have a neurological disorder (see above); Age between 18 and
75; As prospects may be different for individual patients, patients should be
in the chronic stage (> 6 months post acute injuries) or their medical
condition should be relatively stable (for those with a slow progressive
condition), to be judged by the treating medical or psychological specialist,
in order to be able to profit from treatment for a reasonable time period.
Also, the presence of a close other is an inclusion criterion
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Serious neurodegenerative or psychiatric conditions (including addiction)
interfering with treatment
- Incapacity to act, to be judged by the neuropsychologist and/or neurologist.
- Serious cognitive problems (aphasia, neglect, amnesia, dementia) and/or
serious behavioral problems (aggression, apathy) interfering with treatment, to
be judged by neuropsychologist.
- Serious (other) medical conditions or physical inability hindering patients
to come to the hospital/rehabilitation center,
- Not being available of a close other (life partner, family member, close
friend) who can fill out the proxy questionnaires
- Not willing to give permission to send important/unexpected findings to the
general practitioner.
- In addition: unexpected progression of disease during the study can be a
reason to exclude the patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the difference between T2 (long-term follow-up) and<br /><br>T0 of the score on the Dutch version of the Dysexecutive Questionnaire- Social<br /><br>scales proxy version (DEX-Socproxy; Spikman et al., 2013; Westerhof-Evers,<br /><br>2017). This is a measure for informant rated social competent behavior. The<br /><br>difference between T2 and T0 should be significantly larger than the<br /><br>difference in the control group to control for test-retest effects. T2 is<br /><br>chosen because we deem it relevant to establish that treatment effects last<br /><br>over time, that is, are still present at follow-up measurement. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints will be improvements on tests for social cognition,<br /><br>questionnaires for social abilities, social participation, quality of life<br /><br>(QoL), mood, relationship quality, goal attainment scaling (GAS), between T0<br /><br>and T1, and T0 and T2 respectively. </p><br>