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

NCT ID: NCT05478759

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Injury Post Traumatic Stress Disorder

Keywords

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cognition intervention brain injury emotion recognition post traumatic stress disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

20 Veterans with mTBI and PTSD will be randomized to multimodal and attention training or inactive control arm.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MMART and attention training

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

Group Type EXPERIMENTAL

Multimodal affect recognition training

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

computerized attention drill training

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.

Group Type PLACEBO_COMPARATOR

Brain Health Workshop

Intervention Type BEHAVIORAL

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

National Geographic Movies

Intervention Type BEHAVIORAL

participant will watch movies and answer questions after

Interventions

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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.

Intervention Type BEHAVIORAL

Attention Training

computerized attention drill training

Intervention Type BEHAVIORAL

Brain Health Workshop

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

Intervention Type BEHAVIORAL

National Geographic Movies

participant will watch movies and answer questions after

Intervention Type BEHAVIORAL

Other Intervention Names

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MMART Brain HQ BHW movies

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia K. Waid-Ebbs, PhD

Role: PRINCIPAL_INVESTIGATOR

North Florida/South Georgia Veterans Health System, Gainesville, FL

Locations

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North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Julia K Waid-Ebbs, PhD

Role: CONTACT

Phone: (352) 376-1611

Email: [email protected]

Margaret H McCallum

Role: CONTACT

Phone: (352) 376-1611

Email: [email protected]

Facility Contacts

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Margaret H McCallum

Role: primary

Other Identifiers

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D4411-P

Identifier Type: -

Identifier Source: org_study_id