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Completed

NCT Number: NCT02432300

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

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).

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health Facilities

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emotion Builder

Behavioral

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

Primary outcomes

  1. 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). 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.

  2. 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 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 outcomes

  1. 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. 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.

  2. State Trait Anxiety Inventory (STAI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

EmotEd

Industry

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 4, 2015
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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