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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Social functioning - Social Functioning Scale (SFS) [Срок оценки: From enrollment to follow-up, approximately 12 months.]
• Neuropsychiatric behavior problems - Neuropsychiatric behavior Problems Scale (NPS) [Срок оценки: From enrollment to follow-up, approximately 12 months.]
• Relationship quality - Relationship Quality Scale (RQS) [Срок оценки: From enrollment to follow-up, approximately 12 months.]

Вторичные конечные точки (9)

• Executive functioning (social scales) [Срок оценки: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)]
• Social monitoring [Срок оценки: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)]
• Empathy [Срок оценки: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)]
• Neuropsychiatric problems [Срок оценки: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)]
• Cognitive Communication [Срок оценки: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)]
• Marital Satisfaction [Срок оценки: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)]
• Caregiver strain [Срок оценки: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)]
• Recognition of facial affect [Срок оценки: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)]
• Mental state attribution [Срок оценки: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)]

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• GGZ Oost Brabant — Boekel

Идентификаторы

NCT: NCT06923683 · T-ScEmo SCED

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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