Remediation of Emotional Processing Deficits in MS: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Emotional Processing
研究概览
简要总结
This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial. We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS as well
详细描述
This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial RCT). We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS, as well.
All participants will undergo a baseline evaluation assessing emotional processing abilities, cognitive functioning, and psychological functioning. Participants will then be randomized into two groups. During the treatment phase, the experimental group will receive the proposed intervention while the control group will receive a "placebo" treatment. Neuropsychological assessment will be repeated at the end of the intervention.
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
- 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
- •between the ages of 18-
- •diagnosis of Relapsing-Remitting Multiple Sclerosis.
- •can read and speak English fluently.
排除标准
- •history of prior stroke or other neurological disease or injury.
- •history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder.
- •significant alcohol or drug abuse history.
结局指标
主要结局
Emotional Processing
时间窗: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Change in scores on computerized tests of emotional processing
次要结局
- Self report of Quality of Life(Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8))
- Emotional Function(Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8))
研究者
Helen Genova
Research Scientist
Kessler Foundation