Clinical trial NCT06330298: Improving Social Cognition and Social Behaviour in Various Brain Disorders
Official title: Improving Social Cognition and Social Behaviour in Various Brain Disorders.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Multiple Sclerosis
Brain Tumor
Keywords: Neuropsychology
Treatment
Social cognitive disorders
Emotion recognition
Theory of Mind
Social behaviour
Neurological disorders
Stroke
Brain tumour
Mulitple Sclerosis
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.


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.

Primary outcomes:
measure: Change in social behaviour examined by proxy
timeFrame: Through study completion, an average of 8 to 10 months
Secondary outcomes:
measure: Social cognition: Emotion recognition as assessed using the Eckman-60 faces test
timeFrame: Through study completion, an average of 8 to 10 months
measure: Social cognition: Theory of Mind as assessed using the Happé cartoons test
timeFrame: Through study completion, an average of 8 to 10 months
measure: Social cognition: Theory of Mind as assessed using the Faux Pas test
timeFrame: Through study completion, an average of 8 to 10 months
measure: Social cognition: assessed using the Hailing Sentence Completion Test
timeFrame: Through study completion, an average of 8 to 10 months
measure: Demographic information
timeFrame: Through study completion, an average of 8 to 10 months
measure: Self-rated social behaviour as assessed using the Dysexecutive questionnaire Social Scales.
timeFrame: Through study completion, an average of 8 to 10 months
measure: Self-rated social behaviour as assessed using the Interpersonal Reactivity Index
timeFrame: Through study completion, an average of 8 to 10 months
measure: Self-rated social behaviour as assessed using The Dutch version of the BAFQ social scales
timeFrame: Through study completion, an average of 8 to 10 months
measure: Proxy-rated social behaviour as assessed using the Interpersonal Reactivity Index
timeFrame: Through study completion, an average of 8 to 10 months
measure: Proxy-rated social behaviour as assessed using the Socioemotional Dysfunction Scale
timeFrame: Through study completion, an average of 8 to 10 months
measure: Proxy-rated social behaviour as assessed using the Dutch version of the BAFQ social scales
timeFrame: Through study completion, an average of 8 to 10 months
measure: Alexithymia
timeFrame: Through study completion, an average of 8 to 10 months
measure: Life satisfaction
timeFrame: Through study completion, an average of 8 to 10 months
measure: (Social) participation as assessed using the Utrecht Scale for Evaluation of Rehabilitation
timeFrame: Through study completion, an average of 8 to 10 months
measure: (Social) participation as assessed using the Impact on Participation and Autonomy scale
timeFrame: Through study completion, an average of 8 to 10 months
measure: Mood and anxiety
timeFrame: Through study completion, an average of 8 to 10 months
measure: Caregiving burden
timeFrame: Through study completion, an average of 8 to 10 months
measure: Goal attainment
timeFrame: Through study completion, an average of 8 to 10 months
Other outcomes:
measure: Executive functioning as assessed using the Controlled Oral Word Association Test
timeFrame: Baseline
measure: Executive functioning assessed using the Key Search Test
timeFrame: Baseline
measure: Verbal memory
timeFrame: Baseline
measure: Working memory
timeFrame: Baseline
measure: Language
timeFrame: Baseline
measure: Mental speed and attention as assessed using the Trail Making Test
timeFrame: Baseline
measure: Mental speed and attention as assessed using the Symbol Digit Modalities Test
timeFrame: Baseline
measure: Premorbid intelligence
timeFrame: Baseline
measure: Fatigue
timeFrame: Baseline
measure: Health limitations
timeFrame: Baseline
measure: Coping
timeFrame: Baseline
Locations:
city: Deventer
country: Netherlands
facility: Deventer Hospital
state: Overijssel
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG)
name: J.M. Spikman, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: