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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478759
• Other study ID #: D4411-P
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: Julia K Waid-Ebbs, PhD
• Phone: (352) 376-1611
• Email: Julia.Waid-Ebbs[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• Attention Training
computerized attention drill training
• Brain Health Workshop
an education presentation on brain function and cognitive principles of learning with homework and quizzes on information covered.
• National Geographic Movies
participant will watch movies and answer questions after

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System, Gainesville, FL	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).	week 1, week 11, week 22
Secondary	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).	week 1, week 11, week 22
Secondary	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.	week 1, week 11, week 22
Secondary	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.	week 1, week 11, week 22