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

• ClinicalTrials.gov Identifier: NCT02432300
• Recruitment Status: Completed
• First Posted: May 4, 2015
• Results First Posted: November 22, 2017
• Last Update Posted: November 22, 2017
• Sponsor: EmotEd
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Dawn Neumann, Indiana University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Traumatic Brain Injury; Alexithymia	Behavioral: Emotion Builder	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
• Study Start Date: May 2015
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Treatment sessions with a virtual treatment program called Emotion Builder	Behavioral: Emotion Builder; Total of 8 therapy sessions with the Emotion Builder over approximately four (4) weeks (2 sessions a week)

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Indiana

Indiana University Health Facilities

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

EmotEd

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

Investigators

• Principal Investigator: Dawn Neumann, PhD; Indiana University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Neumann D, Malec JF, Hammond FM. Reductions in Alexithymia and Emotion Dysregulation After Training Emotional Self-Awareness Following Traumatic Brain Injury: A Phase I Trial. J Head Trauma Rehabil. 2017 Sep/Oct;32(5):286-295. doi: 10.1097/HTR.0000000000000277.

• Responsible Party: Dawn Neumann, Assistant Research Professor, Department of Physical Medicine and Rehabilitation, IU School of Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT02432300
• Other Study ID Numbers: 1R41HD077967-01A1 ( U.S. NIH Grant/Contract ); 1404681990 ( Other Identifier: Institutional Review Board (IRB) ); 1R41HD077967-01A1 ( U.S. NIH Grant/Contract )
• First Posted: May 4, 2015
• Results First Posted: November 22, 2017
• Last Update Posted: November 22, 2017
• Last Verified: November 2017

Keywords provided by Dawn Neumann, Indiana University:

Traumatic Brain Injury; Alexithymia; Emotions

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Affective Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Behavioral Symptoms