protocolSection identificationModule nctId: NCT06330298, orgStudyIdInfo id: 202000479, briefTitle: Improving Social Cognition and Social Behaviour in Various Brain Disorders, acronym: T-ScEmo4ALL, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-05-31, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Stroke, conditions: Multiple Sclerosis, conditions: Brain Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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 treatmentWaiting 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 T1TBI group T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatmentThe 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., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: 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., whoMasked: INVESTIGATOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Treatment social cognition and emotion regulation (T-ScEmo), outcomesModule primaryOutcomes measure: Change in social behaviour examined by proxy, secondaryOutcomes measure: Social cognition: Emotion recognition as assessed using the Eckman-60 faces test, secondaryOutcomes measure: Social cognition: Theory of Mind as assessed using the Happé cartoons test, secondaryOutcomes measure: Social cognition: Theory of Mind as assessed using the Faux Pas test, secondaryOutcomes measure: Social cognition: assessed using the Hailing Sentence Completion Test, secondaryOutcomes measure: Demographic information, secondaryOutcomes measure: Self-rated social behaviour as assessed using the Dysexecutive questionnaire Social Scales., secondaryOutcomes measure: Self-rated social behaviour as assessed using the Interpersonal Reactivity Index, secondaryOutcomes measure: Self-rated social behaviour as assessed using The Dutch version of the BAFQ social scales, secondaryOutcomes measure: Proxy-rated social behaviour as assessed using the Interpersonal Reactivity Index, secondaryOutcomes measure: Proxy-rated social behaviour as assessed using the Socioemotional Dysfunction Scale, secondaryOutcomes measure: Proxy-rated social behaviour as assessed using the Dutch version of the BAFQ social scales, secondaryOutcomes measure: Alexithymia, secondaryOutcomes measure: Life satisfaction, secondaryOutcomes measure: (Social) participation as assessed using the Utrecht Scale for Evaluation of Rehabilitation, secondaryOutcomes measure: (Social) participation as assessed using the Impact on Participation and Autonomy scale, secondaryOutcomes measure: Mood and anxiety, secondaryOutcomes measure: Caregiving burden, secondaryOutcomes measure: Goal attainment, otherOutcomes measure: Executive functioning as assessed using the Controlled Oral Word Association Test, otherOutcomes measure: Executive functioning assessed using the Key Search Test, otherOutcomes measure: Verbal memory, otherOutcomes measure: Working memory, otherOutcomes measure: Language, otherOutcomes measure: Mental speed and attention as assessed using the Trail Making Test, otherOutcomes measure: Mental speed and attention as assessed using the Symbol Digit Modalities Test, otherOutcomes measure: Premorbid intelligence, otherOutcomes measure: Fatigue, otherOutcomes measure: Health limitations, otherOutcomes measure: Coping, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Deventer Hospital, status: RECRUITING, city: Deventer, state: Overijssel, zip: 7416SE, country: Netherlands, contacts name: M.J.J. Gerritssen, dr., role: CONTACT, geoPoint lat: 52.255, lon: 6.16389, locations facility: University Medical Center Groningen, status: RECRUITING, city: Groningen, zip: 9700VB, country: Netherlands, contacts name: Amber Heegers, MSc., role: CONTACT, phone: +3150 361 4666, email: a.heegers@umcg.nl, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False