Innovative Multimodal and Attention Training to Improve Emotion Communication in Veterans With TBI and PTSD
1 other identifier
interventional
20
1 country
1
Brief Summary
Poor emotion recognition has been associated with poor quality of interpersonal relationships, loss of employment, behavioral problems, reduced social reintegration, social isolation and even suicide. Deficits in emotion recognition are common in traumatic brain injury (TBI) and in post-traumatic stress disorder (PTSD) but these deficits have not been well studied in Veterans with both mild TBI (mTBI) and PTSD. Currently there are no interventions for emotion recognition in Veterans with mTBI and PTSD, and interventions for severe TBI have lacked training of both facial and vocal emotion recognition. In a preliminary study of an innovative combination of facial and vocal modalities, a multimodal affect recognition training (MMART) showed promise but lacked attention training that is an essential component in recognizing emotions in our daily lives. Given the need to improve relationships and productivity in Veterans with mTBI and PTSD, a study is needed to determine the effectiveness of a MMART combined with attention training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 24, 2025
December 1, 2025
3.5 years
July 25, 2022
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Florida Affect Battery (FAB), assessing change
a standardized assessment of emotional affect and prosody recognition. normative scores range from 0-100 for each of the 12 subscales. Higher scores indicate better emotion recognition.
week 1, week 11, week 22
Community Reintegration of Service Members, assessing change
Satisfaction questionnaire of community participation. Scores range from .43 to 2.15. 43 items with five rating options of 1-5. Higher scores indicate better community participation.
week 1, week 11, week 22
Secondary Outcomes (4)
Emotion Recognition Task, assessing change
week 1, week 11, week 22
Continuous Performance Task, assessing change
week 1, week 11, week 22
Attention Index of the Repeatable Battery for the Assessment of Neuropsychological Status, assessing change
week 1, week 11, week 22
Traumatic Brain injury quality of life
week 1, week 11, week 22
Study Arms (2)
MMART and attention training
EXPERIMENTALTraining to recognize affect and prosodic expressions of emotions combined with attention training.
Brain Health Workshop and National Geographic Movies
PLACEBO COMPARATORan inactive arm that matches sessions of intervention. BHW is education about the brain and cognition. National Geographic movies are viewed with the clinician and the participant answers questions about the movies.
Interventions
computerized attention drill training
8 session, trains participants to recognize expression of emotion from a variety of stimuli, including dynamic stimuli (e.g., video instead of still pictures) and it employs both facial and vocal examples of emotion expression.
an education presentation on brain function and cognitive principles of learning with homework and quizzes on information covered.
participant will watch movies and answer questions after
Eligibility Criteria
You may qualify if:
- Veterans with a diagnosis of mTBI and PTSD based on VA/Department of Defense guidelines.
- Emotion recognition deficit
- Attention deficit
- Corrected vision within normal limits
- Hearing within normal limits
- Fluent in English
You may not qualify if:
- premorbid history of schizophrenia
- bipolar disorder
- chronic medical or neurological diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julia K. Waid-Ebbs, PhD
North Florida/South Georgia Veterans Health System, Gainesville, FL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2022
First Posted
July 28, 2022
Study Start
December 1, 2022
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- at closure of study and as long as FITBIR retains the data
- Access Criteria
- dependent on FITBIR criteria
Final data sets will be maintained locally and a de-identified, anonymized dataset will be made available in response to specific requests that meet the criteria described within this document and to data repositories i.e. FITBIR.