Alexithymia, Traumatic Brain Injury
Conditions
Keywords
Traumatic Brain Injury, Alexithymia, Emotions
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.
Interventions
BEHAVIORALEmotion Builder
Total of 8 therapy sessions with the Emotion Builder over approximately four (4) weeks (2 sessions a week)
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
EmotEd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group (Emotion Builder) 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. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Treatment Group (Emotion Builder) |
|---|---|
| Age, Continuous | 46.12 years STANDARD_DEVIATION 11.41 |
| Levels of Emotional Awareness Scale | 36.92 units on a scale STANDARD_DEVIATION 7.88 |
| PHQ 9 (Depression) | 10.77 units on a scale STANDARD_DEVIATION 4.82 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 13 Participants |
| Toronto Alexithymia Scale | 61.54 units on a scale STANDARD_DEVIATION 7.26 |
| Trait Anxiety (State Trait Anxiety Inventory) | 68.38 T score STANDARD_DEVIATION 11.45 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
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.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group (Emotion Builder) | Levels of Emotional Awareness Scale (LEAS) | 44.23 units on a scale | Standard Deviation 5.23 |
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.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group (Emotion Builder) | Toronto Alexithymia Scale-20 (TAS-20) | 52.54 units on a scale | Standard Deviation 11.95 |
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.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group (Emotion Builder) | Patient Health Questionnaire-9 (PHQ-9) as an Assessment of Depression | 9.69 units on a scale | Standard Deviation 5.25 |
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.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group (Emotion Builder) | State Trait Anxiety Inventory (STAI) | 61.54 units on a scale | Standard Deviation 12.08 |