Back to resultsThe Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
Primary Purpose
Traumatic Brain Injury, Alexithymia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotion Builder
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Alexithymia, Emotions
Eligibility 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.
Sites / Locations
- Indiana University Health Facilities
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Treatment sessions with a virtual treatment program called Emotion Builder
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02432300
First Posted
April 24, 2015
Last Updated
November 20, 2017
Sponsor
EmotEd
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT02432300
Brief Title
The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
Official Title
The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
EmotEd
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Alexithymia
Keywords
Traumatic Brain Injury, Alexithymia, Emotions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Treatment sessions with a virtual treatment program called Emotion Builder
Intervention Type
Behavioral
Intervention Name(s)
Emotion Builder
Intervention Description
Total of 8 therapy sessions with the Emotion Builder over approximately four (4) weeks (2 sessions a week)
Primary Outcome Measure Information:
Title
Toronto Alexithymia Scale-20 (TAS-20)
Description
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.
Time Frame
Week 6
Title
Levels of Emotional Awareness Scale (LEAS)
Description
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.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9) as an Assessment of Depression
Description
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.
Time Frame
Week 6
Title
State Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Neumann, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health Facilities
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28060205
Citation
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.
Results Reference
derived
Learn more about this trial
The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
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