Traumatic Brain InjuryNCT02432300
The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
A study testing Emotion Builder in people with Traumatic Brain Injury and Alexithymia, run by EmotEd at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury, Alexithymia
- What is being tested?
- Emotion Builder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health Facilities
Indianapolis, Indiana, 46202
About this study
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).
Read the 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.
- Conditions
- Traumatic Brain Injury, Alexithymia
- Being tested
- Emotion Builder
- Keywords
- Traumatic Brain Injury, Alexithymia, Emotions
- Medical subject headings
- Brain Injuries, Traumatic, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion BuilderBehavioural
Total of 8 therapy sessions with the Emotion Builder over approximately four (4) weeks (2 sessions a week)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Treatment sessions with a virtual treatment program called Emotion Builder Receives: Behavioral: Emotion Builder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 6
Secondary outcomes (2)
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.
Measured: 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.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- EmotEd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Dawn Neumann, Indiana University
- Investigators
- Dawn Neumann, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432300
- Sponsor's protocol ID
- 1R41HD077967-01A1
- Other IDs
- 1404681990, 1R41HD077967-01A1
- Status last verified
- Nov 2017
- First submitted
- 24 Apr 2015
- Last updated
- 22 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28060205
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
- ClinicalTrials.gov ID
- NCT02432300
- Acronym / sponsor ID
- 1R41HD077967-01A1
- Conditions
- Traumatic Brain Injury, Alexithymia
- Keywords
- Traumatic Brain Injury, Alexithymia, Emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- EmotEdIndustry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Posted 22 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Emotion BuilderTreatment sessions with a virtual treatment program called Emotion Builder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion BuilderTotal of 8 therapy sessions with the Emotion Builder over approximately four (4) weeks (2 sessions a week) | Behavioural | Intervention |
Primary outcome
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.
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.
2 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9) as an Assessment of Depression
Time frame: Week 6
State Trait Anxiety Inventory (STAI)
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28060205Neumann 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Neumann, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Builder in people with Traumatic Brain Injury and Alexithymia, run by EmotEd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Alexithymia Scale-20 (TAS-20) (time frame: Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.