The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
Study Details
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 |
|---|---|---|
|
N/A |
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
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
- 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
- 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.
Eligibility Criteria
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1R41HD077967-01A1
- 1404681990
- 1R41HD077967-01A1
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Participants were only enrolled in the treatment if they were found to have met the criteria for moderate to severe alexithymia on the Toronto Alexithymia Scale 20 (>=52). |
| Arm/Group Title | Treatment Group (Emotion Builder) |
|---|---|
| Arm/Group Description | The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants. Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned. |
| Period Title: Overall Study | |
| STARTED | 17 |
| COMPLETED | 13 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Treatment Group (Emotion Builder) |
|---|---|
| Arm/Group Description | The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants. Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned. |
| Overall Participants | 17 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
46.12
(11.41)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
23.5%
|
| Male |
13
76.5%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
17
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Toronto Alexithymia Scale (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
61.54
(7.26)
|
| Levels of Emotional Awareness Scale (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
36.92
(7.88)
|
| PHQ 9 (Depression) (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
10.77
(4.82)
|
| Trait Anxiety (State Trait Anxiety Inventory) (T score) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [T score] |
68.38
(11.45)
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Group (Emotion Builder) |
|---|---|
| Arm/Group Description | The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants. Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned. |
| Measure Participants | 13 |
| Mean (Standard Deviation) [units on a scale] |
52.54
(11.95)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Group (Emotion Builder) |
|---|---|
| Arm/Group Description | The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants. Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned. |
| Measure Participants | 13 |
| Mean (Standard Deviation) [units on a scale] |
44.23
(5.23)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Group (Emotion Builder) |
|---|---|
| Arm/Group Description | The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants. Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned. |
| Measure Participants | 13 |
| Mean (Standard Deviation) [units on a scale] |
9.69
(5.25)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Group (Emotion Builder) |
|---|---|
| Arm/Group Description | The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants. Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned. |
| Measure Participants | 13 |
| Mean (Standard Deviation) [units on a scale] |
61.54
(12.08)
|
Adverse Events
| Time Frame | One year. From the start of participant enrollment until the last day of testing. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Treatment Group (Emotion Builder) | |
| Arm/Group Description | 8 sessions of a web-based treatment, each lasting 60-90 minutes, twice per week over 4 weeks with a clinician research assistant. This treatment aimed to improve emotional awareness and labeling. | |
All Cause Mortality |
||
| Treatment Group (Emotion Builder) | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Treatment Group (Emotion Builder) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/17 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Treatment Group (Emotion Builder) | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/17 (5.9%) | |
| Psychiatric disorders | ||
| Emotional Distress | 1/17 (5.9%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dawn Neumann |
|---|---|
| Organization | EmotEd, LLC |
| Phone | 716-713-5048 |
| dneumann73@gmail.com |
- 1R41HD077967-01A1
- 1404681990
- 1R41HD077967-01A1