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Behavioural Intervention

Combined Metacognitive Training for mTBI/PTSD

N/A
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
Latest mTBI occurred at least 6 months prior to study enrollment.
Family member or friend that is willing to complete a questionnaire.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-intervention, post, 6-month and 1-year follow-up
Awards & highlights

Study Summary

This trial will test a new combined strategy training to help improve cognitive function in veterans with mild traumatic brain injury and post-traumatic stress disorder.

Who is the study for?
This trial is for Veterans who served in OIF-OEF-OND, diagnosed with mild traumatic brain injury (mTBI) and PTSD at least 6 months ago. They must have attention deficits, access to a computer or smartphone with internet, and a friend or family member willing to fill out a questionnaire. Excluded are those with learning disabilities, ongoing litigation related to their injury, recent medication changes for seizures/depression/memory, other cognitive therapy participation, non-fluent English speakers, severe psychiatric history leading to hospitalization.Check my eligibility
What is being tested?
The study tests Goal Management Training combined with Attention Training against Brain Health Workshops and National Geographic Movies in improving cognition for Veterans with mTBI/PTSD. It will compare the effectiveness of these treatments delivered both in-person and via telehealth on executive function and real-life tasks.See study design
What are the potential side effects?
Since this trial involves cognitive training programs rather than medications or invasive procedures, traditional side effects are not expected. However, participants may experience fatigue or frustration during the exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My last mild brain injury was over 6 months ago.
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I have someone who can fill out a questionnaire for me.
Select...
I am a veteran of OIF-OEF-OND with diagnosed mTBI and PTSD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-intervention, post, 6-month and 1-year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention, post, 6-month and 1-year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Composite Executive score of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research
Secondary outcome measures
Change in Attention Network Task
Traumatic Brain Injury
Change in the Test of Grocery Shopping Skills
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Telehealth GMT plus Attention TrainingExperimental Treatment1 Intervention
Goal Management Training is a group metacognitive intervention to improve ability to complete complex task more effectively. 2-hour session are conducted over the VA VideoConnect weekly over 10-weeks. A second weekly session includes Attention training which is conducted one-on-one with the therapist via VA VideoConnect. Participant completed 5-6 hours of homework between sessions
Group II: Inpatient GMT plus Attention TrainingExperimental Treatment1 Intervention
Goal Management Training is a group metacognitive intervention to improve ability to complete complex task more effectively. 2-hour session are conducted in-person weekly over 10-weeks. A second weekly session includes Attention training which is conducted one-on-one with the therapist in the clinic. Participant completed 5-6 hours of homework between sessions.
Group III: Brain Health WorkshopPlacebo Group1 Intervention
Brain Health Workshop includes educational information about the brain to control for GMT and National Geographic Movies is used as a control to equate time with therapist in Attention Training. Each session occurs weekly for 2-hours over 10-weeks.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,606 Previous Clinical Trials
3,305,942 Total Patients Enrolled
Julia K. Waid-Ebbs, PhDPrincipal InvestigatorNorth Florida/South Georgia Veterans Health System, Gainesville, FL
3 Previous Clinical Trials
105 Total Patients Enrolled

Media Library

Goal Management Training plus Attention Training (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05380050 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Inpatient GMT plus Attention Training, Telehealth GMT plus Attention Training, Brain Health Workshop
Post-Traumatic Stress Disorder Clinical Trial 2023: Goal Management Training plus Attention Training Highlights & Side Effects. Trial Name: NCT05380050 — N/A
Goal Management Training plus Attention Training (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05380050 — N/A

Frequently Asked Questions

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

Might I be eligible for enrolment in this investigation?

"This trial is enrolling 63 participants that are between 30 and 50 years of age with an intact mental faculty."

Answered by AI

Could you confirm whether enrollment for this research is still open?

"Affirmative. Clinicaltrials.gov documents indicate that this medical trial is actively enrolling 63 people at 1 location and was initially posted on November 1st, 2022 with the latest update occurring on November 10th of the same year."

Answered by AI

What is the cap for participants of this trial?

"Affirmative. The clinicaltrials.gov website reveals that this experimental research is actively enrolling participants; it was first made available on November 1st 2022 and has been recently updated on the 10th of November 2022. This trial necessitates 63 patients from a single site."

Answered by AI

Are there any age restrictions for participating in this scientific experiment?

"The age range requirements for this trial are between 30 and 50 years old."

Answered by AI
~42 spots leftby Oct 2026