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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432300
• Other study ID #: 1R41HD077967-01A1
• Secondary ID: 14046819901R41HD
• Status: Completed
• Phase: N/A
• First received: April 24, 2015
• Last updated: November 20, 2017
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: November 2017
• Source: EmotEd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Affective Symptoms
• Alexithymia
• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• Emotion Builder
Total of 8 therapy sessions with the Emotion Builder over approximately four (4) weeks (2 sessions a week)

Locations

Country	Name	City	State
United States	Indiana University Health Facilities	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
EmotEd	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toronto Alexithymia Scale-20 (TAS-20)	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.	Week 6
Primary	Levels of Emotional Awareness Scale (LEAS)	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.	Week 6
Secondary	Patient Health Questionnaire-9 (PHQ-9) as an Assessment of Depression	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.	Week 6
Secondary	State Trait Anxiety Inventory (STAI)	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.	Week 6