Treatment for Social Cognition Disorders (T-ScEmo) in Patients With Acquired Brain Injury and Comorbid Neuropsychiatric Problems

The Effectiveness of a Treatment for Social Cognition Disorders (T-ScEmo) in Patients With Acquired Brain Injury and Comorbid Neuropsychiatric Problems

Acquired brain injury (ABI) can lead to a wide range of physical, cognitive, emotional, and social problems. In the recent years, more research has been conducted to examine the impact of ABI on social cognition. Approximately 13%-40% of patients with ABI experience difficulties with social cognition. Social cognition refers to the cognitive processes involved in perceiving, interpreting, and responding to social information. When these processes are disrupted, patients may struggle to (1) understand social situations, (2) interpret the emotions and intentions of others, and (3) respond appropriately in social interactions. This not only results in reduced social engagement for ABI patients, but also places a burden on relationships and proxies. Therefore, it is important to effectively treat social cognition problems in ABI patients.

To date, only a few treatment studies aimed at improving social cognition have been conducted. In 2017, a multifaceted treatment for impairments in social cognition and emotion regulation (T-ScEmo) is developed, which was proven effective in improving multiple aspects of social cognition and emotion regulation. T-ScEmo is now considered as an evidence-based treatment for patients with traumatic brain injury and social cognition problems. However, ABI patients and comorbid neuropsychiatric problems have been excluded in most studies exploring the treatment of social cognition problems after ABI. It is important that the effect of T-ScEmo in this particular group is examined, since 25%-88% of the ABI patients experience neuropsychiatric problems. Comorbidities are thus very prevalent in this ABI population.

Unfortunately, up till now there are no studies examining the effect of T-ScEmo in patients with ABI, comorbid neuropsychiatric problems and social cognition problems. Therefore, the aim of the present study is threefold:

1. To examine the effect of a treatment for impairments in social cognition and emotion regulation (T-ScEmo) on social cognition problems;
2. To examine the effect of T-ScEmo on social interaction, communication and neuropsychiatric behavioral problems;
3. To examine the effect of T-ScEmo on quality of partner relationship in patients with ABI and comorbid psychiatric problems.

Study Overview

• Status: Enrolling by invitation
• Conditions: Acquired Brain Injury; Neuropsychiatric Symptoms
• Intervention / Treatment: Behavioral: Treatment for social cognition disorders (T-ScEmo)

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord Brabant
    • Boekel, Noord Brabant, Netherlands, 5427EM
      • GGZ Oost Brabant

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

All patients:

• have an established and documented history of ABI and current neuropsychiatric problems. When patients are referred to our institution, a team of clinical neuropsychologists, psychiatrists, and a high-educated nurse estimate whether patients meet these criteria by using a transdiagnostic tool.
• have social cognition problems. These impairments in social cognition are established by defective scores on the Facial Expression of Emotion-Stimuli and Tests (FEEST) and/or (if available) frontal lesions visible on computed tomographic scan/magnetic resonance image, indicating higher risk on social behavioral problems. The FEEST is already used in standard care.
• are at least 6 months post-injury to avoid the effects of spontaneous recovery.
• are between 18 and 70 years.
• have a significant other/proxy to fill in questionnaires and participate in the treatment. A life partner (persons living together in an intimate relationship, either married or unmarried) is preferred. When patients don't have a life partner, they are asked to bring an adult proxy (a close friend or family member) with whom they have frequent contact in daily life, preferably someone who already knew the patient from before the ABI.

Exclusion Criteria:

• not being able to receive the T-ScEmo treatment, for example due to severe cognitive impairment
• not speaking the Dutch language.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: There is only one arm in this study, since it is a SCED.

Behavioral: Treatment for social cognition disorders (T-ScEmo); T-ScEmo is an evidence-based, multifaceted treatment protocol for poor social cognition and emotion regulation impairments in patients with ABI. T-ScEmo is implemented as standard practice in the Netherlands. In total, the treatment consists of 20 1-hour sessions. The treatment is divided into extended psychoeducation for patient and proxy and 3 modules, including emotion perception (module 1), perspective taking and understanding social information (module 2), and goal-directed social behavior (module 3). These three modules are interdependent and strengthen each other. Therefore, the developers strongly recommend to offer all three modules. The presence of a proxy is required in the first psycho-education session and during the third module. The first and second modules are invariant (10 sessions together), but in the third module, therapists can adjust the content to individual needs and personal goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social functioning - Social Functioning Scale (SFS)	Functioning in social situations is measured by using a Social Functioning Scale (SFS), where patients and proxies rate the patient's functioning in social situations on a 10-point scale from 1 ("not at all") to 10 ("entirely"). The following question will be asked to patients and proxies: "How satisfied are you today with your (or your partner's) functioning in social situations?" Higher scores indicate more satisfaction.	From enrollment to follow-up, approximately 12 months.
Neuropsychiatric behavior problems - Neuropsychiatric behavior Problems Scale (NPS)	Neuropsychiatric behavior problems are measured by using a Neuropsychiatric behavior Problems Scale (NPS), where patients and proxies rate the patient's neuropsychiatric behavior problems on a 10-point scale from 1 ("not at all") to 10 ("entirely"). The following question will be asked to patients and proxies: "To what extent did you (or your partner) experience neuropsychiatric behavioral problems today?". 'Neuropsychiatric behavioral problems' refer to the neuropsychiatric problems that the client is (most) affected by (e.g. irritability, aggression, disinhibition, depression, anxiety). Higher scores indicate more neuropsychiatric problems.	From enrollment to follow-up, approximately 12 months.
Relationship quality - Relationship Quality Scale (RQS)	Relationship quality is measured by using the Relationship Quality Scale (RQS), where patients and proxies rate the quality of their relationship on a 10-point scale from 1 ("not at all") to 10 ("entirely"). Higher scores indicate more satisfaction.	From enrollment to follow-up, approximately 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive functioning (social scales)	The Dysexecutive Questionnaire - Social scales (DEX-Soc-self; DEX-Soc-proxy) will be filled out by participant and proxy. The DEX subscales 'Meta cognition' (items 2, 5, 12, 16, 20), 'Social convention' (items 9, 12, 13, 20), and 'Behavioral emotional self-regulation' (items 3, 7, 8) will be filled out. The items are scored on a 4-point scale (0 = never to 4 = very often), with higher scores indicating more problems.	At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Social monitoring	The Brock's Adaptive Functioning Questionnaire Social monitoring scale (BAFQ-SMself, BAFQ-SM-proxy) will be filled out by participant and proxy. The items are scored on a 5-point scale (1 = almost never to 5 = almost ever), with higher scores indicating more problems.	At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Empathy	The IRI (Interpersonal Reactivity Index) will be filled out by the participant. The IRI is a 28-item multidimensional scale that measures empathy. The scale measures both the cognitive and affective aspects of empathy. The IRI consists of 4 subscales, each containing 7 items. Higher scores indicate a higher level of empathy. The Brock's Adaptive Functioning Questionnaire Empathy scale (BAFQ-Emp-self, BAFQ-Emp-proxy) will be filled out by participant and proxy. The items are scored on a 5-point scale (1 = almost never to 5 = almost ever), with higher scores indicating more problems.	At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Neuropsychiatric problems	The Neuropsychiatrische Vragenlijst-Questionnaire (NPI-Q) will be filled out by the proxy. The NPI-Q is a validated questionnaire, aimed at inventorying neuropsychiatric symptoms that have occurred in the past month. For each domain, the answer is initially given as "Yes" (present) or "No" (absent). If the answer is "No," the informant proceeds to the next question. If the answer is "Yes," the informant assesses both the severity of the symptoms that occurred in the past month (three-point scale) and the psychological burden it caused for him or her (six-point scale). The NPI-Q provides a severity rating and an assessment of the emotional burden for each reported symptom, as well as summed total scores for Severity and Emotional Burden. Higher scores indicate more problems.	At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Cognitive Communication	The the La Trobe Questionnaire (LCQ-S / LCQ-O) will be filled out by participant and proxy. The LCQ-S is a 30-item self-report questionnaire that assesses perceived communication quality in patients with ABI. Items of the LCQ-O are the same as those that appear in de LCQ-S, except they are phrased in the third person. Higher scores indicate more problems.	At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Marital Satisfaction	The Dutch Marital Satisfaction and Communication Questionnaire (DMSCQ) will be filled out by participant and proxy. The DMSCQ is a 16-item questionnaire that disentangles marital satisfaction, negative communication and open communication on a 7-point scale ("not at all applicable" to "highly applicable")	At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Caregiver strain	The Caregiver Strain Index (CSI) will be filled out by the proxy to detect caregiver strain. The CSI is a 13-item questionnaire with dichotomous yes/no answers. Higher scores indicate more problems.	At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Recognition of facial affect	The FEEST (Sixty faces test) will be administered to test the recognition of facial affect. Participants are presented with 60 photographs of faces displaying the various primary emotions (happiness, sadness, fear, angst, disgust, and surprise), with 10 faces of each primary emotion. The photographs are shown for 3 seconds. Higher scores indicate a better performance.	At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Mental state attribution	The Cartoon test will be administered to test mental state attribution. The Cartoon test incorporates 12 cartoons displaying humorous situations. Higher scores indicate a better performance.	At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other neuropsychological tests	Other neuropsychological tests are used to assess possible effects of cognitive (dis)functioning on effectiveness of the treatment, neuropsychological tests on attention, executive functioning, and memory will be administered before treatment: Trail Making Test (TMT) A + B, TMT B/A; BADS Zoo-map; 15-word test.	At baseline

Collaborators and Investigators

• Sponsor: Ggz Oost Brabant
• Collaborators: Maastricht University; UMC Groningen, Groningen, the Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Cognition Disorders
• Other Study ID Numbers: T-ScEmo SCED

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
• product manufactured in and exported from the U.S.: No