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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT05478759
Collaborator
(none)
20
1
2
25
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Multimodal affect recognition training
  • Behavioral: Attention Training
  • Behavioral: Brain Health Workshop
  • Behavioral: National Geographic Movies
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
20 Veterans with mTBI and PTSD will be randomized to multimodal and attention training or inactive control arm.20 Veterans with mTBI and PTSD will be randomized to multimodal and attention training or inactive control arm.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Innovative Multimodal and Attention Training to Improve Emotion Communication in Veterans With TBI and PTSD
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: MMART and attention training

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

Behavioral: Multimodal 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.
Other Names:
  • MMART
  • Behavioral: Attention Training
    computerized attention drill training
    Other Names:
  • Brain HQ
  • 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
    an education presentation on brain function and cognitive principles of learning with homework and quizzes on information covered.
    Other Names:
  • BHW
  • Behavioral: National Geographic Movies
    participant will watch movies and answer questions after
    Other Names:
  • movies
  • Outcome Measures

    Primary Outcome Measures

    1. Florida Affect Battery (FAB), assessing change [week 1, week 11, week 22]

      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.

    2. Community Reintegration of Service Members, assessing change [week 1, week 11, week 22]

      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.

    Secondary Outcome Measures

    1. Emotion Recognition Task, assessing change [week 1, week 11, week 22]

      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).

    2. Continuous Performance Task, assessing change [week 1, week 11, week 22]

      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).

    3. Attention Index of the Repeatable Battery for the Assessment of Neuropsychological Status, assessing change [week 1, week 11, week 22]

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

    4. Traumatic Brain injury quality of life [week 1, week 11, week 22]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 50 Years
    Sexes Eligible for Study:
    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:
    • premorbid history of schizophrenia

    • bipolar disorder

    • chronic medical or neurological diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 North Florida/South Georgia Veterans Health System, Gainesville, FL Gainesville Florida United States 32608

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Julia K. Waid-Ebbs, PhD, North Florida/South Georgia Veterans Health System, Gainesville, FL

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT05478759
    Other Study ID Numbers:
    • D4411-P
    First Posted:
    Jul 28, 2022
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by VA Office of Research and Development
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2022