Clinical trial NCT06923683: Treatment for Social Cognition Disorders (T-ScEmo) in Patients With Acquired Brain Injury and Comorbid Neuropsychiatric Problems
Official title: The Effectiveness of a Treatment for Social Cognition Disorders (T-ScEmo) in Patients With Acquired Brain Injury and Comorbid Neuropsychiatric Problems
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Acquired Brain Injury
Neuropsychiatric Symptoms
Lead sponsor: Ggz Oost Brabant
Sponsor class: OTHER
Collaborators: name: Maastricht University
name: UMC Groningen, Groningen, the Netherlands
First posted: 2025-04-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Social functioning - Social Functioning Scale (SFS)
timeFrame: From enrollment to follow-up, approximately 12 months.
measure: Neuropsychiatric behavior problems - Neuropsychiatric behavior Problems Scale (NPS)
timeFrame: From enrollment to follow-up, approximately 12 months.
measure: Relationship quality - Relationship Quality Scale (RQS)
timeFrame: From enrollment to follow-up, approximately 12 months.
Secondary outcomes:
measure: Executive functioning (social scales)
timeFrame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
measure: Social monitoring
timeFrame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
measure: Empathy
timeFrame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
measure: Neuropsychiatric problems
timeFrame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
measure: Cognitive Communication
timeFrame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
measure: Marital Satisfaction
timeFrame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
measure: Caregiver strain
timeFrame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
measure: Recognition of facial affect
timeFrame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
measure: Mental state attribution
timeFrame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Other outcomes:
measure: Other neuropsychological tests
timeFrame: At baseline
Locations:
city: Boekel
country: Netherlands
facility: GGZ Oost Brabant
state: Noord Brabant
Study officials:
References: