Innovative Multimodal and Attention Training to Improve Emotion Communication in Veterans With TBI and PTSD
Primary Purpose
Brain Injury, Post Traumatic Stress Disorder
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Multimodal affect recognition training
Attention Training
Brain Health Workshop
National Geographic Movies
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injury focused on measuring cognition, intervention, brain injury, emotion recognition, post traumatic stress disorder
Eligibility Criteria
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
Sites / Locations
- North Florida/South Georgia Veterans Health System, Gainesville, FLRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MMART and attention training
Brain Health Workshop and National Geographic Movies
Arm Description
Training to recognize affect and prosodic expressions of emotions combined with attention training.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
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).
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.
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.
Full Information
NCT ID
NCT05478759
First Posted
July 25, 2022
Last Updated
January 4, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05478759
Brief Title
Innovative Multimodal and Attention Training to Improve Emotion Communication in Veterans With TBI and PTSD
Official Title
Innovative Multimodal and Attention Training to Improve Emotion Communication in Veterans With TBI and PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Post Traumatic Stress Disorder
Keywords
cognition, intervention, brain injury, emotion recognition, post traumatic stress disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
20 Veterans with mTBI and PTSD will be randomized to multimodal and attention training or inactive control arm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MMART and attention training
Arm Type
Experimental
Arm Description
Training to recognize affect and prosodic expressions of emotions combined with attention training.
Arm Title
Brain Health Workshop and National Geographic Movies
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multimodal affect recognition training
Other Intervention Name(s)
MMART
Intervention Description
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
Intervention Name(s)
Attention Training
Other Intervention Name(s)
Brain HQ
Intervention Description
computerized attention drill training
Intervention Type
Behavioral
Intervention Name(s)
Brain Health Workshop
Other Intervention Name(s)
BHW
Intervention Description
an education presentation on brain function and cognitive principles of learning with homework and quizzes on information covered.
Intervention Type
Behavioral
Intervention Name(s)
National Geographic Movies
Other Intervention Name(s)
movies
Intervention Description
participant will watch movies and answer questions after
Primary Outcome Measure Information:
Title
Florida Affect Battery (FAB), assessing change
Description
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
Title
Community Reintegration of Service Members, assessing change
Description
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 Outcome Measure Information:
Title
Emotion Recognition Task, assessing change
Description
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
Title
Continuous Performance Task, assessing change
Description
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
Title
Attention Index of the Repeatable Battery for the Assessment of Neuropsychological Status, assessing change
Description
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
Title
Traumatic Brain injury quality of life
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia K Waid-Ebbs, PhD
Phone
(352) 376-1611
Email
Julia.Waid-Ebbs@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret H McCallum
Phone
(352) 376-1611
Ext
5223
Email
Margaret.McCallum@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia K. Waid-Ebbs, PhD
Organizational Affiliation
North Florida/South Georgia Veterans Health System, Gainesville, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret H McCallum
Phone
352-376-1611
Ext
5223
Email
Margaret.McCallum@va.gov
First Name & Middle Initial & Last Name & Degree
Yi Zhang, PhD
Phone
(352) 548-6000
Ext
5046
Email
yizhang@ufl.edu
First Name & Middle Initial & Last Name & Degree
Julia K. Waid-Ebbs, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
at closure of study and as long as FITBIR retains the data
IPD Sharing Access Criteria
dependent on FITBIR criteria
IPD Sharing URL
https://fitbir.nih.gov/
Learn more about this trial
Innovative Multimodal and Attention Training to Improve Emotion Communication in Veterans With TBI and PTSD
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