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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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Community Reintegration of Service Members, assessing change
Florida Affect Battery (FAB), assessing change
Secondary outcome measures
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
~100

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,264 Total Patients Enrolled
Julia K. Waid-Ebbs, PhDPrincipal InvestigatorNorth Florida/South Georgia Veterans Health System, Gainesville, FL
3 Previous Clinical Trials
148 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the eligibility requirements for this experiment?

"20 individuals who have post-traumatic stress disorder (PTSD) and between the ages of 25-50 are eligible for this trial. In order to participate, potential candidates must meet certain requirements which are as follows: being a veteran with a diagnosis of mTBI and PTSD based on VA/Department of Defense guidelines, an emotion recognition deficit, attention deficit, corrected vision within normal limits, hearing within normal limits, and finally being fluent in English."

Answered by AI

Are we looking for new participants in this research project?

"According to the information available on clinicaltrials.gov, this trial is no longer recruiting patients. This study was originally posted on December 1st, 2022 and was last edited on July 25th, 2022. Although this specific trial is not enrolling new participants, there are 736 other studies that are still looking for subjects."

Answered by AI

If an older patient wants to enroll in this research, will they be accepted?

"This clinical trial is enrolling individuals aged 25-50."

Answered by AI

What does the FDA have to say about affect recognition training?

"While Phase 2 trials don't have the same level of data supporting efficacy, there is some clinical evidence backing up the safety of multimodal affect recognition training-- so it received a score of 2."

Answered by AI
~6 spots leftby Nov 2024