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Emotion & Attention Training for TBI and PTSD

Phase 2
Recruiting
Led By Julia K. Waid-Ebbs, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, week 11, week 22

Summary

This trial will test whether a multimodal affect recognition training (MMART), which includes training in both facial and vocal emotion recognition, can improve emotion recognition and attention in Veterans with mTBI and PTSD.

Who is the study for?
This trial is for Veterans who have mild traumatic brain injury (mTBI) and PTSD, can hear and see normally, speak English fluently, and struggle with recognizing emotions or paying attention. It's not for those with chronic diseases, schizophrenia, or bipolar disorder.
What is being tested?
The study tests a new training program combining National Geographic Movies, Multimodal affect recognition training (MMART), Attention Training, and Brain Health Workshops to help improve emotion communication in veterans.
What are the potential side effects?
Since the interventions are non-medical trainings involving movies and workshops rather than drugs or medical procedures, significant side effects are not expected. However, participants may experience fatigue or emotional discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 11, week 22
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, week 11, week 22 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Community Reintegration of Service Members, assessing change
Florida Affect Battery (FAB), assessing change
Secondary study objectives
Attention Index of the Repeatable Battery for the Assessment of Neuropsychological Status, assessing change
Continuous Performance Task, assessing change
Emotion Recognition Task, assessing change
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MMART and attention trainingExperimental Treatment2 Interventions
Training to recognize affect and prosodic expressions of emotions combined with attention training.
Group II: Brain Health Workshop and National Geographic MoviesPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Attention Training
2018
N/A
~550

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,577 Total Patients Enrolled
Julia K. Waid-Ebbs, PhDPrincipal InvestigatorNorth Florida/South Georgia Veterans Health System, Gainesville, FL
3 Previous Clinical Trials
134 Total Patients Enrolled

Media Library

Attention Training Clinical Trial Eligibility Overview. Trial Name: NCT05478759 — Phase 2
Traumatic Brain Injury Research Study Groups: MMART and attention training, Brain Health Workshop and National Geographic Movies
Traumatic Brain Injury Clinical Trial 2023: Attention Training Highlights & Side Effects. Trial Name: NCT05478759 — Phase 2
Attention Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05478759 — Phase 2
~0 spots leftby Nov 2024