Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury: A Piolt Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in scores on Facial Expression Identification Task (FEIT)
研究概览
简要总结
This study will examine the efficacy of a clinical intervention for improving emotional processing in individuals with MS and TBI.(1)The main outcome measure will be changes in emotional processing measures from pre to post treatment.
(2)This study will also assess the impact of the emotional processing intervention on changes in pre and post treatment depression and anxiety, as well as fatigue.(3) This study will additionally measure the impact of the emotional processing intervention on cognitive functioning, specifically processing speed, attention and executive abilities. This will be accomplished through the completion of a neuropsychological battery prior to and following the completion of treatment.(4)Finally, the investigators will measure the impact of the intervention on quality of life and social functioning, utilizing a pre and post treatment assessment consisting of measures of self-efficacy, quality of life, functional abilities, and awareness.
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
- •diagnosis of Multiple Sclerosis or Traumatic Brain Injury
- •Fluent in English
- •processing speed impairment (based on evaluation)
排除标准
- •currently taking steroids and/or benzodiazepines
- •prior stroke or neurological diease
- •history of significant pyschiatric 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
Change in scores on Facial Expression Identification Task (FEIT)
时间窗: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
The FEIT assesses one's ability to correctly identify and discriminate emotions from faces
次要结局
- Change in scores on Satisfaction with Life Scale (SWLS)(Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8))
- Change in scores on Emotion Regulation Questionnaire (ERQ)(Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8))
研究者
Jean Lengenfelder
Associate Director, Traumatic Brain Injury Lab
Kessler Foundation