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

Not Applicable

Completed

• Conditions: Traumatic Brain Injury; Alexithymia
• Interventions: Behavioral: Emotion Builder

• Registration Number: NCT02432300
• Lead Sponsor: EmotEd

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 Description

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.

Study Timeline

• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-04-28
• Study Start: 2015-05
• Study First Posted: 2015-05-04
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2017-03-01
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-20
• Last Update Submitted: 2017-11-20
• Results First Posted: 2017-11-22
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Emotion Builder	Treatment sessions with a virtual treatment program called Emotion Builder

Primary Outcome Measures

Name	Time	Method
Toronto Alexithymia Scale-20 (TAS-20)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9) as an Assessment of Depression	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. The 9 items describe problems associated with depression, and participants must rate how often they have been bothered by the problems in the last 2 weeks on a 0-3 scale. The scores are summed for a total depression score, ranging from 0-27, which higher scores indicating greater depression.
State Trait Anxiety Inventory (STAI)	Week 6	The STAI is a self-report measure of state and trait anxiety (20 items each). The trait anxiety subscale was the variable of interest for this study. Higher scores indicate more trait or state anxiety. Scores for each scale range from 20-80, with higher scores indicating greater anxiety. The raw scores were converted into T scores using age and gender norms provided by the authors for the STAI. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Higher T scores were still indicative of higher anxiety. We reported T scores for trait anxiety.

Trial Locations

Locations (1)

Indiana University Health Facilities; 🇺🇸 Indianapolis, Indiana, United States