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Active, not recruitingNCT05478759Updated Oct 2, 2026

Innovative Multimodal and Attention Training to Improve Emotion Communication in Veterans With TBI and PTSD

An interventional study of Multimodal affect recognition training and Attention Training in Brain Injury and Post Traumatic Stress Disorder, sponsored by VA Office of Research and Development. Active, not recruiting at 1 site in United States. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
25 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

Background. 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. 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. Currently there are no interventions for emotion recognition deficits in Veterans with mTBI and PTSD, and interventions conducted in civilians with 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 with significant improvement on the Florida Affect Battery (FAB) but lacked attention training that is an essential component in recognizing rapidly changing emotions in our everyday lives. Attention training using Brain HQ targets the required attention factors underlying emotion recognition. Given the need to improve relationships and productivity in Veterans with mTBI and PTSD, a randomized controlled trial is needed to determine the effectiveness of an innovative MMART combined with attention training to improve emotion recognition and everyday function.

Objective \& Hypotheses. The objective of this randomized controlled trial is to determine the treatment effect of a MultiModal Affect Recognition Training (MMART) combined with attention training in Veterans with TBI/PTSD.

Hypothesis 1. MMART combined with attention training will significantly improve performance on tests of emotion recognition.

Hypothesis 2: Treatment gains will translate to functional activities. Primary measures. Florida Affect Battery (FAB) and the Community Reintegration in Service members (CRIS).

Secondary measures. Emotion Recognition Task (ERT), attention index of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Continuous Performance Task and the TBI Quality of Life (TBI-QOL) Ability to Participate in Social Roles and Activities.

Methods. 20 Veterans with mTBI and PTSD will be randomized to either the combined training or an inactive control group. Both groups will attend 16, one-hour in-person sessions over 8 weeks. Outcomes will be assessed at pre-, post-, 3 month-post-treatment. A linear regression will be used to determine significant improvement of the treatment group over the control group, with t-tests to demonstrate within group improvement. Effect size calculations will be used to determine the power needed for a future Merit proposal.

02

Conditions studied

  • Brain Injury
  • Post Traumatic Stress Disorder

Keywords

  • cognition
  • intervention
  • brain injury
  • emotion recognition
  • post traumatic stress disorder
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 16 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Premorbid history of schizophrenia
  • Bipolar disorder
  • Chronic medical or neurological diseases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    MMART and attention training

    Training to recognize affect and prosodic expressions of emotions combined with attention training.

    Behavioral: Multimodal affect recognition training · Behavioral: Attention Training

  • Placebo comparator
    Brain Health Workshop and National Geographic Movies

    an 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.

    Behavioral: Brain Health Workshop · Behavioral: National Geographic Movies

Interventions

  • BehavioralMultimodal affect recognition 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.

    Also known as: MMART

  • BehavioralAttention Training

    computerized attention drill training

    Also known as: Brain HQ

  • BehavioralBrain Health Workshop

    an education presentation on brain function and cognitive principles of learning with homework and quizzes on information covered.

    Also known as: BHW

  • BehavioralNational Geographic Movies

    participant will watch movies and answer questions after

    Also known as: movies

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: week 1, week 11, week 22

  2. 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.

    Time frame: week 1, week 11, week 22

Secondary outcomes

  1. Emotion Recognition Task, assessing change

    Computerized assessment of emotional affect recognition. Correct responses range from 0-48 (higher scores indicate better emotion recognition) and correct response time ranges from 0 to infinity (lower scores indicate quicker response time).

    Time frame: week 1, week 11, week 22

  2. Continuous Performance Task, assessing change

    Computerized measures of sustained attention. 100 trials with accuracy ranging from 0-100 (higher scores indicate better attention) and response time from 0-60 (lower scores indicate quicker response time).

    Time frame: week 1, week 11, week 22

  3. Attention Index of the Repeatable Battery for the Assessment of Neuropsychological Status, assessing change

    Digit span and symbol digit to assess attention. Scaled scores range from 1-19, with higher scores indicating better attention.

    Time frame: week 1, week 11, week 22

  4. Traumatic Brain injury quality of life

    Quality of life questionnaire about community participation. 59 items with scores ranging from 59-295, with higher scores indicating better community participation.

    Time frame: week 1, week 11, week 22

07

Study locations

1 site
  • North Florida/South Georgia Veterans Health System, Gainesville, FL
    Gainesville, Florida 32608-1135, United States
08

References and documents

Study documents

  • Informed consent form · Aug 31, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Analytic code

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: documents
1 update, last Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Minor edits only
    + 1 other change: documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05478759
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Jul 28, 2022
Start date
Dec 1, 2022
Primary completion
Jul 1, 2026
Completion
Dec 24, 2026 (estimated)
Last update
Oct 2, 2026

Study contacts

Julia K. Waid-Ebbs, PhD
principal investigator · North Florida/South Georgia Veterans Health System, Gainesville, FL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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