A Social Emotion Regulation Intervention in MS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Well-being: Depression
研究概览
简要总结
The current project will examine effectiveness of an intervention based on the concept of the social regulation of emotion. The intervention is designed to improve well-being in individuals with MS by leveraging participants' existing social support. Effectiveness will be tested on a sample of 42 individuals with MS, half of whom will receive the intervention and half of which will receive an inactive control. Investigators will document changes resulting from treatment on self-reported levels of stress, depression, and quality of life. Intervention evaluation will expand scientific knowledge of emotion regulation disruption in MS, and potentially identify a novel and highly efficient means of treatment.
详细描述
Multiple sclerosis (MS) is a progressive and debilitating neurological disease which not only affects a patient's physical health, but also adversely affects their mental health. Depressed mood is common in MS, and poor mental health in individuals with MS has wide-ranging consequences on social relationships and community integration. The preponderance of negative emotions and sparsity of positive emotions in MS are attributable in part to ineffective emotion regulation strategies. Thus, the clinical trial seeks to evaluate the effectiveness of an intervention which instructs individuals on using the social regulation of emotion.
The social regulation of emotion occurs when a one's emotional state benefits from an interaction with another person, such as when seeking comfort from a trusted friend. The current intervention was designed to leverage existing social relationships for emotional support in a manner which should strengthen the perception of social support and also reinforce existing relationships. The primary goal of this trial is to examine changes in mental well-being after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple Sclerosis diagnosis
- •English language fluency
排除标准
- •currently taking steroids or benzodiazepines
- •within 30 days of an exacerbation
- •history of substance abuse
- •diagnosis of bipolar, schizophrenia, epilepsy, stroke
结局指标
主要结局
Well-being: Depression
时间窗: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)
Change in scores on a self-report questionnaire of depression (the Center for Epidemiologic Studies Depression Scale, a 20-item scale with higher scores indicating greater depression)
Well-being: Stress
时间窗: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)
Change in scores on a self-report questionnaire of stress (the Perceived Stress Scale, a 10-item scale with higher scores reflecting higher stress)
Well-being: Quality of life
时间窗: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)
Change in scores on a self-report questionnaire of quality of life (the Satisfaction with Life Scale, a five item scale where higher scores reflect higher satisfaction)
次要结局
- Perceived social support(Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6))