Improving Social Cognition and Social Behaviour in Various Brain Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke Multiple Sclerosis Brain Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

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.

Study Groups

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Experimental condition: Receives T-ScEmo Treatment

Experimental group. Receives T-ScEmo Treatment during the study between T0 and T1

Group Type EXPERIMENTAL

Treatment social cognition and emotion regulation (T-ScEmo)

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Treatment social cognition and emotion regulation (T-ScEmo)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No