N/A
N=17
The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
Traumatic Brain Injury · Alexithymia
Bottom Line
View on ClinicalTrials.gov: NCT02432300 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Toronto Alexithymia Scale-20 (TAS-20) — 52.54 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Emotion Builder (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EmotEd
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toronto Alexithymia Scale-20 (TAS-20) |
52.54 | — |
| PRIMARY Levels of Emotional Awareness Scale (LEAS) |
44.23 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) as an Assessment of Depression |
9.69 | — |
| SECONDARY State Trait Anxiety Inventory (STAI) |
61.54 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT02432300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.