Improving Social Cognition and Social Behaviour in Various Brain Disorders.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Change in social behaviour examined by proxy
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- 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.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Experimental condition: Receives T-ScEmo Treatment
Experimental group. Receives T-ScEmo Treatment during the study between T0 and T1
Intervention: Treatment social cognition and emotion regulation (T-ScEmo) (Behavioral)
Waiting list group: Will be on waiting list instead of treatment
Waiting list group: Will be on waiting list for instead of the treatment for the duration of the treatment between T0 and T1.
Outcomes
Primary Outcomes
Change in social behaviour examined by proxy
Time Frame: Through study completion, an average of 8 to 10 months
The main study parameter will be the difference between baseline (T0) and follow-up (T2) on Dysexecutive Questionnaire Social scales proxy version (DEX-Socproxy; Spikman et al., 2013; Westerhof-Evers, 2017). This scale is scored by the involved proxy of the patient (life partner, family member, friend) and measures the social aspects in daily life: 1) social convention, 2) behavioural-emotional selfregulation 3) metacognition. A higher outcome means more behavioural complaints.
Secondary Outcomes
- Caregiving burden(Through study completion, an average of 8 to 10 months)
- Life satisfaction(Through study completion, an average of 8 to 10 months)
- Social cognition: Emotion recognition as assessed using the Eckman-60 faces test(Through study completion, an average of 8 to 10 months)
- Social cognition: Theory of Mind as assessed using the Faux Pas test(Through study completion, an average of 8 to 10 months)
- Self-rated social behaviour as assessed using the Dysexecutive questionnaire Social Scales.(Through study completion, an average of 8 to 10 months)
- Proxy-rated social behaviour as assessed using the Interpersonal Reactivity Index(Through study completion, an average of 8 to 10 months)
- Social cognition: Theory of Mind as assessed using the Happé cartoons test(Through study completion, an average of 8 to 10 months)
- Alexithymia(Through study completion, an average of 8 to 10 months)
- (Social) participation as assessed using the Utrecht Scale for Evaluation of Rehabilitation(Through study completion, an average of 8 to 10 months)
- Mood and anxiety(Through study completion, an average of 8 to 10 months)
- Social cognition: assessed using the Hailing Sentence Completion Test(Through study completion, an average of 8 to 10 months)
- Demographic information(Through study completion, an average of 8 to 10 months)
- Self-rated social behaviour as assessed using the Interpersonal Reactivity Index(Through study completion, an average of 8 to 10 months)
- Self-rated social behaviour as assessed using The Dutch version of the BAFQ social scales(Through study completion, an average of 8 to 10 months)
- Proxy-rated social behaviour as assessed using the Socioemotional Dysfunction Scale(Through study completion, an average of 8 to 10 months)
- Proxy-rated social behaviour as assessed using the Dutch version of the BAFQ social scales(Through study completion, an average of 8 to 10 months)
- (Social) participation as assessed using the Impact on Participation and Autonomy scale(Through study completion, an average of 8 to 10 months)
- Goal attainment(Through study completion, an average of 8 to 10 months)