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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
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 belowSelect...
I am a veteran of OIF-OEF-OND with diagnosed mTBI and PTSD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-intervention, post, 6-month and 1-year follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-intervention, post, 6-month and 1-year follow-up
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 moreTrial 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.
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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,621 Previous Clinical Trials
3,323,438 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My last mild brain injury was over 6 months ago.I understand the study's expectations and risks and can consent.I have been hospitalized for a psychiatric condition.I have a neurological condition not caused by brain injury.I have someone who can fill out a questionnaire for me.You have had a learning disability before.You have had issues with drinking too much alcohol or using drugs in the past year.You have a reading test score below 90.I am not fluent in English.I have recently changed my medication for seizures, depression, or memory issues.You didn't pass a memory test called the Test of Memory Malingering (TOMM).You have a significantly lower than average score on a test that measures attention.I am a veteran of OIF-OEF-OND with diagnosed mTBI and PTSD.
Research Study Groups:
This trial has the following groups:- Group 1: Inpatient GMT plus Attention Training
- Group 2: Telehealth GMT plus Attention Training
- Group 3: Brain Health Workshop
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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