Trial Title:
Improving Social Cognition and Social Behaviour in Various Brain Disorders
NCT ID:
NCT06330298
Condition:
Stroke
Multiple Sclerosis
Brain Tumor
Conditions: Official terms:
Brain Neoplasms
Multiple Sclerosis
Brain Diseases
Sclerosis
Conditions: Keywords:
Neuropsychology
Treatment
Social cognitive disorders
Emotion recognition
Theory of Mind
Social behaviour
Neurological disorders
Stroke
Brain tumour
Mulitple Sclerosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Experimental condition T0, baseline measurement at point of inclusion (at least > 6
months post-acute injuries) T1, post measurement within 2 weeks after treatment T2,
follow-up measurement within 3 - 5 months after treatment
Waiting list condition T0, baseline measurement at point of inclusion (at least > 6
months post-acute injuries) T1, post measurement within 3 months after T0 T2, follow-up
measurement within 3 - 5 months after T1
TBI group T1, post measurement within 2 weeks after treatment T2, follow-up measurement
within 3 - 5 months after treatment
The participating patients are randomly allocated into two groups: an experimental
condition and a waiting list condition.
In addition, a group of patients with Traumatic Brain Injury will receive T-ScEmo
following regular care.
Primary purpose:
Treatment
Masking:
Single (Investigator)
Masking description:
The neuropsychologist who leads T1 and T2 measurements will be masked for the fact of
which patient will be draw in which clinical condition (experimental group or control
group), however this cannot be guaranteed since patients may talk about their experience.
Intervention:
Intervention type:
Behavioral
Intervention name:
Treatment social cognition and emotion regulation (T-ScEmo)
Description:
T-ScEmo is a multifaceted treatment protocol that has the overall aim to improve social
cognition, regulation of social behaviour and social participation in everyday life
(Westerhof et al., 2017; 2019). The treatment includes, in addition to practicing social
cognitive skills throughout the treatment, close involvement of a significant other, and
homework assignments. The treatment consists of three modules that address 1) perception
of social information including facial expressions of emotions, 2) perspective taking and
understanding of social information and 3) regulation of social behaviour. The treatment
contains 15-one hour live treatment sessions with a neuropsychologist and 5 online
practice sessions, once or twice a week. In the online sessions, the patient can practice
the information at home as a neuropsychologist is available for questions. When patients
find it too difficult to practice individually at home, there is a opportunity to offer
these sessions as live sessions
Arm group label:
Experimental condition: Receives T-ScEmo Treatment
Summary:
Impairments in aspects of social cognition are disorder-transcending: these have been
demonstrated in various neurological disorders, such as traumatic brain injury (TBI),
stroke, brain tumours (both low grade glioma's and meningioma's) and multiple sclerosis
(MS). Social cognition involves processing of social information, in particular the
abilities to perceive social signals, understand others and respond appropriately
(Adolphs 2001). Crucial aspects of social cognition are the recognition of facial
expressions of emotions, perspective taking (also referred to as mentalizing or Theory of
Mind), and empathy. Impairments in social cognition can have a large negative impact on
self-care, communication, social and professional functioning, and thus on quality of
life of patients.
Recently, a first multi-faceted treatment for social cognitive impairments in TBI was
developed and evaluated; T-ScEmo (Training Social Cognition and Emotion). T-ScEmo turned
out to be effective in reducing social cognitive symptoms and improving daily life social
functioning in this particular group, with effects lasting over time (Westerhof-Evers et
al, 2017, 2019).
Unfortunately, up till now there are no evidence based, transdiagnostic treatment
possibilities available for these impeding social cognition impairments in neurological
patient groups, other than TBI. Therefore the aim of the present study is to investigate
whether T-ScEmo is effective for social cognition disorders in patients with different
neurological impairments, such as stroke (including subarachnoidal haemorrhage (SAH)),
brain tumours, MS, infection (meningitis, encephalitis) and other. The secondary
objective is to determine which patient related factors are of influence on treatment
effectiveness. In short, hopefully this study can contribute to a treatment possibility
for social cognition disorders for all patients with various neurological disorders.
It is expected that T-ScEmo will be effective for various neurological disorders, based
on previous research of Westerhof-Evers et al. (2017, 2019). Since social cognition
disorders within patients with traumatic brain injury do all have the same ethiology it
is expected that the treatment will show the same effects for patients with various
neurological disorders. Therefore it is expected that patients will improve on social
cognition, social participation and quality of life and social behaviour, that these
results will last over time.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients should have social cognitive disorders that show by means of problems in
emotion recognition, perspective taking, ToM, showing empathy, or behaviour.
- Patients should have a neurological disorder; stroke (including patients with
subarachnoid haemorrhage), Multiple sclerosis (MS), both relapsing remitting,
primary and secondary progressive variants, Brain tumours (meningioma's, low grade
gliomas) and other categories of neurological disorders including brain damage:
(i.e. infections (meningitis, encephalitis), post anoxic encephalopathy, adult
survivors of childhood brain tumours).
- Patients should be aged between 18 and 75
- Patients should be in the chronic stage (> 6 months post-acute injuries) or their
medical condition should be relatively stable (for patients with a slow progressive
conditions), to be judged by the treating medical or psychological specialist, in
order to be able to profit from treatment for a reasonable time period.
Exclusion Criteria:
- 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
behavioural 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 centre
- 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.
- Unexpected progression of disease during the study can be a reason to exclude the
patient
- Not sufficient command of the Dutch Language.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Deventer Hospital
Address:
City:
Deventer
Zip:
7416SE
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
M.J.J. Gerritssen, dr.
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9700VB
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Amber Heegers, MSc.
Phone:
+3150 361 4666
Email:
a.heegers@umcg.nl
Start date:
May 31, 2021
Completion date:
January 31, 2025
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06330298
