Effectiveness of a Novel Theory of Mind Training for People With Multiple Sclerosis: a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reading the Mind from the Eyes (RMET)
研究概览
简要总结
Theory of Mind (ToM) is the ability to understand and attribute mental states to ourselves and others. People with Multiple Sclerosis (pwMS) could present an impairment of this ability, with negative consequences on their social relationships and Quality of Life (QoL). We aimed to design and implement a novel ToM rehabilitation training, testing its efficacy on the promotion of emotional and mental states understanding, on QoL and on the alexithymia traits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Relapsing-Remitting (RR), Secondary Progressive (SP) and Primary Progressive (PP) MS;
- •age ≥ 18 and ≤ 75 years;
- •years of education ≥ 5;
- •no change of pharmacological treatment in the 6 months before the enrollment;
- •no clinical relapses or use of steroid treatment during 3 months before the enrollment;
- •provided informed consent for study participation.
排除标准
- •history of nervous system disorders different from MS;
- •unstable psychiatric illness, such as psychosis or major depression;
- •severe disability with Expanded Disability Status Scale (EDSS) score > 7.5;
- •severe cognitive impairment that would not enable PwMS to answer to questionnaires correctly (i.e. dementia), according to the patient's medical records.
研究组 & 干预措施
ToM training
ToM training was composed of six lessons two times a week. Through several types of stimuli, the trainer worked together with the participant to comprehend and hypothesize interpretations of the emotions and social interactions, providing discussion occasions to enhance the attribution of mental states and emotions. Every lesson had a duration of 45/60 minutes in order to avoid excessive fatigue in the participant.
干预措施: Rehabilitation training (Behavioral)
Non mentalistic training
ToM training was composed of six lessons two times a week. Through several types of stimuli, the trainer worked together with the participant to provide a historical and descriptive overview of cinema movies, TV news, documentaries, newspapers, and advertising. Every lesson had a duration of 45/60 minutes in order to avoid excessive fatigue in the participant.
干预措施: Rehabilitation training (Behavioral)
结局指标
主要结局
Reading the Mind from the Eyes (RMET)
时间窗: 4 weeks
A measure of affective ToM
Strange Stories
时间窗: 4 weeks
A measure of advanced ToM
Faux pas
时间窗: 4 weeks
A measure of both cognitive and affective advanced ToM
False Belief Task
时间窗: 4 weeks
A measure of cognitiveToM
次要结局
- Montreal Cognitive Assessment (MoCA)(4 weeks)
- The Brief Repeatable Battery of Neuropsychological Test (BRB-NT)(4 weeks)
- Toronto Alexithymia Scale (TAS-20)(4 weeks)
- Multiple Sclerosis Quality of Life 54 questionnaire (MSQOL54)(4 weeks)