CompletedNot Applicable

Metacognitive Training to Enhance Strategy Use in Blast-Related TBI

United States51 participantsStarted 2013-10-01

Plain-language summary

Enhanced Goal Management Training (GMT) is a 10-week group or individual therapy that teaches strategies to improve an individual's ability to complete everyday tasks. This research study will test the effect of GMT on 36 OEF/OIF Veterans compared to a control group of 16 OEF/OIF Veterans receiving a Brain Health Workshop. The results will provide information to conduct future research with a larger group of patients or to identify which patients demonstrate more benefit from the training.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 2 incidences of blast-related mTBI according to the American Congress of Rehabilitation Medicine, any of three following criteria: * loss of consciousness \<30 minutes, a Glasgow Coma Scale of 13 * loss of memory for events immediately before and after the event (24 hours alteration of mental state at the time of accident) * focal neurological deficits that may, or may not, be transient (ACRM, 1993) * Diagnosis must be documented in the medical record by a physician or neuropsychologist. * Frontal Lobe impairment will be determined by 1.5 standard deviations below the mean on either the D-KEFS Color Word Interference Testorthe EXAMINER composite score. * Age 18 to 55 years. * At least 6 months post injury. * Family member or friend that is willing to answer questionnaires and provide feedback on questionnaires and completion of homework. Exclusion Criteria: * History of pre-morbid learning disability. * History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization. * Neurological disease unrelated to TBI (seizure disorder, stroke, ADHD). * Score \< 90 on National Adult Reading Test. * Failure of validity testing on the Test of Memory Malingering (TOMM) * Reported alcohol or substance abuse within the past year, or such abuse documented in medical record. * Reported involvement in current litigation. * Changes within the past month of medications known to affect cognitive functions e.g. benzodiazepines, opioi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Computerized Tower Of London (cTOL)

Timeframe: Baseline, 10 weeks

Trial details

NCT IDNCT00857207

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2019-12-23

Results submitted2021-01-29

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