Remediation of Emotional Processing Deficits in MS
Remediation of Emotional Processing Deficits in MS: A Randomized Clinical Trial
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New Jersey
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East Hanover、New Jersey、美国、07936
- Kessler Foundation
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- between the ages of 18-65.
- diagnosis of Relapsing-Remitting Multiple Sclerosis.
- can read and speak English fluently.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Experimental Group
Participants in the experimental group will receive emotional processing training exercises administered on a laptop computer.
They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
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Participants in the experimental group will receive computerized exercises administered on a laptop computer.
They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
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安慰剂比较：Control Group
Participants in the control group will meet with the examiner the same frequency and for the same duration as those in the experimental group. They will receive placebo control exercises administered on a laptop computer. |
Participants in the control group will receive computerized control exercises administered on a laptop computer.
They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Emotional Processing
大体时间：Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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Change in scores on computerized tests of emotional processing
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Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Emotional Function
大体时间：Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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Change in scores on self-report of emotional functioning, measured via questionnaire
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Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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Self report of Quality of Life
大体时间：Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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Change in scores on self-report of quality of life, measured via questionnaire
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Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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合作者和调查者
调查人员
- 首席研究员：Helen Genova, PhD、Research Scientist
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.