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

NCT06923683 | Enrolling By Invitation

• 1 other identifier: T-ScEmo SCED
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acquired Brain Injury; Neuropsychiatric Symptoms

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Executive functioning (social scales)

  At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)

• Social monitoring

  At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)

• Empathy

  At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)

• Neuropsychiatric problems

  At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)

• Cognitive Communication

  At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)

Other Outcomes (1)

• Other neuropsychological tests

  At baseline

Study Arms (1)

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

EXPERIMENTAL

Behavioral: Treatment for social cognition disorders (T-ScEmo)

Interventions

Treatment for social cognition disorders (T-ScEmo) BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ggz Oost Brabant: lead
• Maastricht University: collaborator
• UMC Groningen, Groningen, the Netherlands: collaborator

Study Sites (1)

GGZ Oost Brabant

Boekel, North Brabant, 5427EM, Netherlands

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: April 11, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)