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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
Veterans who have served in OIF-OEF-OND and have been diagnosed with both a mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) based on the joint criteria of the Veterans' Affairs and Department of Defense (VA & DoD).
Be between 18 and 65 years old
Must not have
Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation).
History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-intervention, post, 6-month and 1-year follow-up

Summary

This trial will test a new treatment combining goal management and computer-based attention training for Veterans with mild brain injuries and PTSD. The goal is to improve their focus, problem-solving skills, and daily functioning. The study will compare in-person and telehealth delivery methods. Goal Management Training (GMT) has been previously tested for improving cognitive functioning in individuals with PTSD.

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.
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.
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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I am a veteran of OIF-OEF-OND with diagnosed mTBI and PTSD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I understand the study's expectations and risks and can consent.
Select...
I have been hospitalized for a psychiatric condition.
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I have a neurological condition not caused by brain injury.
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I am not fluent in English.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the Composite Executive score of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research
Secondary study objectives
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for PTSD, such as Goal Management Training plus Computerized Attention Training, focus on cognitive rehabilitation through structured goal-setting and computerized exercises. These methods aim to enhance attention and executive function, which are often compromised in PTSD patients. By improving these cognitive skills, patients can better manage their symptoms, leading to improved daily functioning and reduced distress. This approach is crucial for PTSD patients as it directly addresses the cognitive deficits that exacerbate their condition.
Goal-Oriented Attention Self-Regulation Training Improves Executive Functioning in Veterans with Post-Traumatic Stress Disorder and Mild Traumatic Brain Injury.Improvement in executive functioning after Goal-Oriented Attentional Self-Regulation training is associated with reduction in PTSD hyperarousal symptoms among veterans with comorbid PTSD and mild TBI.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,585 Total Patients Enrolled
Julia K. Waid-Ebbs, PhDPrincipal InvestigatorNorth Florida/South Georgia Veterans Health System, Gainesville, FL
3 Previous Clinical Trials
91 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
~31 spots leftby Oct 2026