Improving Social Cognition and Social Behaviour in Various Brain Disorders (T-ScEmo4ALL)

Improving Social Cognition and Social Behaviour in Various Brain Disorders.

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 Overview

• Status: Recruiting
• Conditions: Stroke; Multiple Sclerosis; Brain Tumor
• Intervention / Treatment: Behavioral: Treatment social cognition and emotion regulation (T-ScEmo)

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: A Heegers, MSc.; Phone Number: +31503614666; Email: a.heegers@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700VB
    • Recruiting
    • University Medical Center Groningen
    • Contact: Amber Heegers, MSc.; Phone Number: +3150 361 4666; Email: a.heegers@umcg.nl
  • Overijssel
    • Deventer, Overijssel, Netherlands, 7416SE
      • Recruiting
      • Deventer Hospital
      • Contact: M.J.J. Gerritssen, dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental condition: Receives T-ScEmo Treatment; Experimental group. Receives T-ScEmo Treatment during the study between T0 and T1	Behavioral: 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in social behaviour examined by proxy	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.	Through study completion, an average of 8 to 10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social cognition: Emotion recognition as assessed using the Eckman-60 faces test	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.	Through study completion, an average of 8 to 10 months
Social cognition: Theory of Mind as assessed using the Happé cartoons test	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.	Through study completion, an average of 8 to 10 months
Social cognition: Theory of Mind as assessed using the Faux Pas test	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.	Through study completion, an average of 8 to 10 months
Social cognition: assessed using the Hailing Sentence Completion Test	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.	Through study completion, an average of 8 to 10 months
Demographic information	Demographic information such as age, sex, educational level, will be obtained from medical records and anamnesis.	Through study completion, an average of 8 to 10 months
Self-rated social behaviour as assessed using the Dysexecutive questionnaire Social Scales.	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.	Through study completion, an average of 8 to 10 months
Self-rated social behaviour as assessed using the Interpersonal Reactivity Index	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.	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	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.	Through study completion, an average of 8 to 10 months
Proxy-rated social behaviour as assessed using the Interpersonal Reactivity Index	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.	Through study completion, an average of 8 to 10 months
Proxy-rated social behaviour as assessed using the Socioemotional Dysfunction Scale	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.	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	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.	Through study completion, an average of 8 to 10 months
Alexithymia	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.	Through study completion, an average of 8 to 10 months
Life satisfaction	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.	Through study completion, an average of 8 to 10 months
(Social) participation as assessed using the Utrecht Scale for Evaluation of Rehabilitation	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.	Through study completion, an average of 8 to 10 months
(Social) participation as assessed using the Impact on Participation and Autonomy scale	The level of societal participation will be measured with the Impact on Participation and Autonomy (IPA). A higher outcome means lower participation rate.	Through study completion, an average of 8 to 10 months
Mood and anxiety	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.	Through study completion, an average of 8 to 10 months
Caregiving burden	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.	Through study completion, an average of 8 to 10 months
Goal attainment	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.	Through study completion, an average of 8 to 10 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive functioning as assessed using the Controlled Oral Word Association Test	Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects. Executive functioning will be measured with the Controlled Oral Word Association Test (COWAT).	Baseline
Executive functioning assessed using the Key Search Test	Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects. Executive functioning will be measured with the Key Search Test of the Behavioural Assessment of the Dysexecutive Syndrome.	Baseline
Verbal memory	Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects. Verbal memory will be measured with Dutch version of the Rey Auditory Verbal Learning Test (15 Words Test).	Baseline
Working memory	Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects. Working memory will be measured with the Digit Span Test of the Wechsler Adult Intelligence Scale IV.	Baseline
Language	Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects. Language will be measured with the semantic fluency test.	Baseline
Mental speed and attention as assessed using the Trail Making Test	Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects. Mental speed and attention will be measured with the Trail Making Test (TMT).	Baseline
Mental speed and attention as assessed using the Symbol Digit Modalities Test	Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects. Mental speed will be measured with the Symbol Digit Modalities Test (SDMT).	Baseline
Premorbid intelligence	Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects. Premorbid intelligence will be measured with Dutch version of the Adult Reading Test (NLV).	Baseline
Fatigue	Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects. The level of physical and mental fatigue will be measured with the Dutch Multifactor Fatigue Scale (DMFS). This scale has a range between 38 and 190. A higher outcome means more complaints.	Baseline
Health limitations	Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects. Health related physical and practical limitations will be measured with the RAND-36 Health Survey. A higher outcome means better functioning.	Baseline
Coping	Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects. Coping will be measured with the Utrecht Coping List (UCL) A higher outcome means a better fitting coping style.	Baseline

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: J.M. Spikman, Prof. Dr., Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG)

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Treatment; Stroke; Neuropsychology; Emotion recognition; Neurological disorders; Theory of Mind; Brain tumour; Mulitple Sclerosis; Social behaviour; Social cognitive disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Neoplasms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Multiple Sclerosis; Sclerosis; Brain Neoplasms; Brain Diseases
• Other Study ID Numbers: 202000479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No