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Treating Emotional Processing Impairments in Individuals With TBI

2021年2月23日 更新者:Helen Genova、Kessler Foundation

Treating Emotional Processing Impairments in Individuals With TBI: A Randomized Controlled Trial

The current project will examine the impact of an emotional processing intervention on emotional processing abilities in a sample of 50 persons with moderate to severe TBI. Outcome will be assessed across 3 domains. We will document changes resulting from treatment: (1) in emotional processing tasks (2) in other areas of function including QOL, social functioning, mood and cognition that are also likely to be impacted (3) in brain structure and function. The examination of efficacy in the above three areas will further our knowledge of emotional processing deficits in TBI and more importantly, identify an effective means of treating such deficits.

研究概览

详细说明

Emotional processing deficits have a significant negative impact on the lives of persons with TBI. There is emerging research indicating that, in addition to cognitive and behavioral impairments, social and emotional difficulties following TBI are common and are related to significant problems in social relationships, poor social participation, impaired empathy, and a high degree of caregiver stress. Emotional processing is a critical component of social cognition, including the abilities to both identify and discriminate basic universal emotions. The stability of emotional processing deficits following TBI indicates that these impairments likely impact individuals with TBI consistently across the lifespan, and do not appear to resolve with time.

The goals of the trial are to (a) Evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with TBI, (b) Evaluate the improvement of secondary outcomes of psychological, cognitive, and functional abilities following the emotional processing intervention in individuals with TBI, (c) To examine differences in brain activation patterns during emotional processing following treatment in individuals with TBI, BOLD activation in the experimental group will be compared to BOLD patterns of the control group during performance of the QFDT, a facial affect recognition task.

研究类型

介入性

注册 (预期的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New Jersey
      • East Hanover、New Jersey、美国、07936
        • 招聘中
        • Kessler Foundation

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • diagnosis of Traumatic Brain Injury (TBI)
  • can read and speak English fluently

Exclusion Criteria:

  • prior stroke or neurological disease.
  • 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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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).
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).
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).

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
Facial Expression Identification Task (FEIT)
大体时间: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.
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

次要结果测量

结果测量
措施说明
大体时间
Emotion Regulation Questionnaire (ERQ)
大体时间:Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
The ERQ is a self-report measure of the use of 2 emotional regulation strategies: cognitive reappraisal and expressive suppression.
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Satisfaction with Life Scale (SWLS)
大体时间:Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
The SWLS is a self-report measure of quality of life.
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Helen Genova, PhD、Kessler Foundation

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年9月1日

初级完成 (预期的)

2021年5月1日

研究完成 (预期的)

2021年5月1日

研究注册日期

首次提交

2017年12月8日

首先提交符合 QC 标准的

2017年12月8日

首次发布 (实际的)

2017年12月14日

研究记录更新

最后更新发布 (实际的)

2021年2月25日

上次提交的符合 QC 标准的更新

2021年2月23日

最后验证

2021年2月1日

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.

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