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| ID | Type | Description | Link |
|---|---|---|---|
| 1404681990 | Other Identifier | Institutional Review Board (IRB) | |
| 1R41HD077967-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Treatment sessions with a virtual treatment program called Emotion Builder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emotion Builder | Behavioral | Total of 8 therapy sessions with the Emotion Builder over approximately four (4) weeks (2 sessions a week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 6 |
| 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. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Neumann, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Facilities | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28060205 | Derived | 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. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Week 6 |
|
One year. From the start of participant enrollment until the last day of testing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group (Emotion Builder) | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emotional Distress | Psychiatric disorders | Non-systematic Assessment | Participant said that he did not like the treatment or how it made him feel. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Neumann | EmotEd, LLC | 716-713-5048 | dneumann73@gmail.com |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D000342 | Affective Symptoms |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Week 6 |
| 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. | Week 6 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Toronto Alexithymia Scale | Measures emotional awareness (difficulty identifying feelings), difficulty describing feelings, and 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. | Because 4 participants withdrew, we provide only baseline data here for those who completed the intervention (n=13). | Mean | Standard Deviation | units on a scale |
|
| Levels of Emotional Awareness Scale | Participants must respond how they think they would feel and how another person would feel in response to a 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. | Because 4 participants withdrew, we provide only baseline data here for those who completed the intervention (n=13). | Mean | Standard Deviation | units on a scale |
|
| PHQ 9 (Depression) | The PHQ-9 is a subjective measure of depression. There are 9 items describing 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. | Because 4 participants withdrew, we provide only baseline data here for those who completed the intervention (n=13). | Mean | Standard Deviation | units on a scale |
|
| Trait Anxiety (State Trait Anxiety Inventory) | 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 (higher scores indicated higher anxiety). The raw scores were converted into T scores using age and gender norms provided by the STAI authors. A T score of 50 represents the mean. A difference of 10 from the mean indicates a difference of 1 standard deviation. Higher T scores still indicated higher anxiety. We reported T scores for trait anxiety. | Because 4 participants withdrew, we provide only baseline data here for those who completed the intervention (n=13). | Mean | Standard Deviation | T score |
|
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Week 6 |
|
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Week 6 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Week 6 |
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| 0 |
| 17 |
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| 17 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |