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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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).

Detailed Summary: 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.
Sponsor: EmotEd

Current Primary Outcome:

• Toronto Alexithymia Scale-20 (TAS-20) [ Time Frame: Week 6 ]
  This is a 20-item self-report questionnaire comprised of three sub-constructs (Difficulty Identifying feelings, Difficulty Describing Feelings, Externally-oriented Thinking)
• Levels of Emotional Awareness Scale (LEAS) [ Time Frame: Week 6 ]
  The LEAS is comprised of ten hypothetical scenarios that are three or four sentences in length. Participants are asked to infer how they and another person would feel given a described situation (open-ended responses).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Patient Health Questionnaire-9 (PHQ-9) as an assessment of depression [ Time Frame: Week 6 ]
  The PHQ-9 is a self-report questionnaire designed to assess depression through nine questions that come directly from the DSM-IV signs and symptoms of major depression.
• State Trait Anxiety Inventory (STAI) [ Time Frame: Week 6 ]
  This is a self-report measure of state and trait anxiety (20 items each).

Original Secondary Outcome: Same as current

Information By: EmotEd

Dates:
Date Received: April 24, 2015
Date Started: May 2015
Date Completion:
Last Updated: August 1, 2016
Last Verified: August 2016