Improving Social Cognition and Social Behaviour in Various Brain Disorders
- Conditions
- Brain TumorStrokeMultiple Sclerosis
- Interventions
- Behavioral: Treatment social cognition and emotion regulation (T-ScEmo)
- Registration Number
- NCT06330298
- Lead Sponsor
- University Medical Center Groningen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental condition: Receives T-ScEmo Treatment Treatment social cognition and emotion regulation (T-ScEmo) Experimental group. Receives T-ScEmo Treatment during the study between T0 and T1
- Primary Outcome Measures
Name Time Method Change in social behaviour examined by proxy 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 Outcome Measures
Name Time Method Social cognition: Emotion recognition as assessed using the Eckman-60 faces test Through study completion, an average of 8 to 10 months Performance on neuropsychological test measuring emotion recognition; Eckman-60 faces test (EFT). This test has a range between 0 and 60. A higher outcome means a better performance.
Social cognition: Theory of Mind as assessed using the Faux Pas test Through study completion, an average of 8 to 10 months Performance on neuropsychological test measuring Theory of Mind: Faux Pas test. This test has a range between 0 and 10. A higher outcome means a better performance.
Self-rated social behaviour as assessed using the Dysexecutive questionnaire Social Scales. Through study completion, an average of 8 to 10 months Self-reated social behaviour will be measured with a self rating on the Dysexecutive questionnaire Social Scales. Measuring the social aspects in daily life: 1) social convention, 2) behavioural-emotional selfregulation 3) metacognition. This scale has a range between 0 and 80. A higher outcome means more complaints.
Proxy-rated social behaviour as assessed using the Interpersonal Reactivity Index Through study completion, an average of 8 to 10 months Proxy-rated social behavior will be measured with the Interpersonal Reactivity Index, proxy version (IRI). This scale has a range between 0 and 108. A higher outcome means less behavioural complaints.
Caregiving burden Through study completion, an average of 8 to 10 months The extend to which proxies experience a burden in taking care of the patient wil be measured with the Zarit burden interview. This scale has a range between 0 and 48. A higher outcome means more burden.
Social cognition: Theory of Mind as assessed using the Happé cartoons test Through study completion, an average of 8 to 10 months Performance on neuropsychological test measuring Theory of Mind; Happé cartoons test. This test has a range between 0 and 36. A higher outcome means a better performance.
Alexithymia Through study completion, an average of 8 to 10 months The presence of alexithymia will be measured with a self-rating on the Toronto Alexithymia Scale (TAS-20). This scale has a range between 20 and 100. A higher outcome means more complaints.
(Social) participation as assessed using the Utrecht Scale for Evaluation of Rehabilitation Through study completion, an average of 8 to 10 months The level of societal participation will be measured with the scores on the Utrecht Scale for Evaluation of Rehabilitation (USER-P). A higher outcome means higher participation rate.
Mood and anxiety Through study completion, an average of 8 to 10 months The level of mood and anxiety will be obtained with the Hospital Anxiety and Depression Scale (HADS). This scale has a range between 0 and 42. A higher outcome means more complaints.
Life satisfaction Through study completion, an average of 8 to 10 months Quality of life will be determined with a self-rating on the Life Satisfaction Questionnaire (LSQ-9). This scale has a range between 6 and 54. A higher outcome means a higher subjective quality of life.
Social cognition: assessed using the Hailing Sentence Completion Test Through study completion, an average of 8 to 10 months Performance on neuropsychological test measuring inhibition; Hailing Sentence Completion Test. This test has a range between 1 and 10. A higher outcome means a better performance.
Demographic information Through study completion, an average of 8 to 10 months Demographic information such as age, sex, educational level, will be obtained from medical records and anamnesis.
Self-rated social behaviour as assessed using the Interpersonal Reactivity Index Through study completion, an average of 8 to 10 months Self-rated social behavior will be measured with the Interpersonal Reactivity Index (IRI). This scale has a range between 0 and 108. A higher outcome means less behavioural complaints.
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 Self-rated social behavior will be measured with The Dutch version of the BAFQ social scales (BAFQ-SOC). Moreover, patients answer if they have changed on that certain topic after brain damage. A higher outcome means less behavioural complaints and more change.
Proxy-rated social behaviour as assessed using the Socioemotional Dysfunction Scale Through study completion, an average of 8 to 10 months Proxy-rated social behavior will be measured with the Socioemotional Dysfunction Scale (SDS). This scale has a range between 40 and 200. A higher outcome means more complaints.
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 Proxy-rated social behavior will be measured with the Dutch version of the BAFQ social scales, proxy version (BAFQ-SOC). Moreover, proxies answer if patients have changed on that certain topic after brain damage. A higher outcome means less behavioural complaints and more change.
(Social) participation as assessed using the Impact on Participation and Autonomy scale Through study completion, an average of 8 to 10 months The level of societal participation will be measured with the Impact on Participation and Autonomy (IPA). A higher outcome means lower participation rate.
Goal attainment Through study completion, an average of 8 to 10 months The extent to which patients in the treatment condition improve on their set treatment goals will be measured with the Goal Attainment Scale (GAS). This scale has a range between 1 and 10. A higher outcome means better attainment.
Trial Locations
- Locations (2)
Deventer Hospital
🇳🇱Deventer, Overijssel, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands