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临床试验/NCT02432300
NCT02432300已完成不适用

The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury

EmotEd2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
EmotEd
入组人数
17
试验地点
2
主要终点
Toronto Alexithymia Scale-20 (TAS-20)

研究概览

简要总结

The purpose of this study is to examine a web-based training program for treating emotional problems in people who have suffered a traumatic brain injury (TBI).

详细描述

This is a pilot study to examine how subjects with TBI feel about the virtual reality program as a treatment and to assess the effectiveness of the virtual reality program at increasing subjects' awareness and understanding of emotions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

入选标准

  • TBI (injury due to an external physical force);
  • Moderate to severe TBI, defined either by74 Glasgow Coma Score at time of injury (≤12), or post-traumatic amnesia (≥1 day), or loss of consciousness (≥30 minutes);
  • ≥1 year post-injury;
  • between 18-65 years old;
  • Have a moderate to high alexithymia score (≥52) on the TAS-2070 at screening.
  • Exclusion criteria:
  • Diagnosed with pre-morbid neurological disorders (e.g. stroke, autism, alzheimer's disease, Parkinson's disease);
  • Formerly diagnosed with a developmental disability;
  • Pre-morbid diagnosis of major psychiatric disorders (e.g. schizophrenia);
  • Unable to follow directions;
  • Uncorrected visual or hearing impairments that would prevent sufficient task participation;
  • No access to reliable transportation.

排除标准

  • 未提供

结局指标

主要结局

Toronto Alexithymia Scale-20 (TAS-20)

时间窗: Week 6

This is a 20-item self-report questionnaire comprised of three sub-constructs (Difficulty Identifying feelings, Difficulty Describing Feelings, Externally-oriented Thinking). The full scale range is 20-100 (higher scores indicate higher alexithymia). Subscales are summed to compute a total score Scores between 52 and 60 indicate moderate alexithymia; scores 61 and higher indicate high alexithymia.

Levels of Emotional Awareness Scale (LEAS)

时间窗: Week 6

The LEAS is comprised of ten hypothetical scenarios that are three or four sentences in length. Participants must respond how they think they would feel and how another person would feel in response to the hypothetical scenario. The more discrete emotions (e.g., bad vs sad) receive higher points, as well as blended emotions (e.g. sad and angry). There are 10 items on this measure. The minimum score for each item is 0 and the max score for each item is 5. The item scores are summed to calculate a total score. Thus, the total scores range from 0-50; 0=lowest awareness and 50=highest awareness. A computerized scoring system and parallel forms were used.

次要结局

  • Patient Health Questionnaire-9 (PHQ-9) as an Assessment of Depression(Week 6)
  • State Trait Anxiety Inventory (STAI)(Week 6)

研究者

发起方
EmotEd
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Dawn Neumann

Assistant Research Professor, Department of Physical Medicine and Rehabilitation, IU School of Medicine

Indiana University

研究点 (2)

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