The Effectiveness of a Treatment for Social Cognition Disorders (T-ScEmo) in Patients With Acquired Brain Injury and Comorbid Neuropsychiatric Problems
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Social functioning - Social Functioning Scale (SFS)
研究概览
简要总结
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:
- To examine the effect of a treatment for impairments in social cognition and emotion regulation (T-ScEmo) on social cognition problems;
- To examine the effect of T-ScEmo on social interaction, communication and neuropsychiatric behavioral problems;
- To examine the effect of T-ScEmo on quality of partner relationship in patients with ABI and comorbid psychiatric problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •not being able to receive the T-ScEmo treatment, for example due to severe cognitive impairment
- •not speaking the Dutch language.
研究组 & 干预措施
There is only one arm in this study, since it is a SCED.
干预措施: Treatment for social cognition disorders (T-ScEmo) (Behavioral)
结局指标
主要结局
Social functioning - Social Functioning Scale (SFS)
时间窗: From enrollment to follow-up, approximately 12 months.
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.
Neuropsychiatric behavior problems - Neuropsychiatric behavior Problems Scale (NPS)
时间窗: From enrollment to follow-up, approximately 12 months.
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.
Relationship quality - Relationship Quality Scale (RQS)
时间窗: From enrollment to follow-up, approximately 12 months.
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.
次要结局
- 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))
- Marital Satisfaction(At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline))
- Caregiver strain(At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline))
- Recognition of facial affect(At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline))
- Mental state attribution(At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline))