Metacognitive Training to Enhance Strategy Use in Blast-Related TBI

Completed · Not applicable

Conditions studied: Brain Concussion, Blast Injuries

In brief

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.

Key facts

Study ID

NCT00857207

Run by

VA Office of Research and Development

People needed

51

Starts

2013-10-01

Expected to finish

2019-12-23

Last updated by the study team

2021-03-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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, opioids, antidepressants and antipsychotics.
• Currently enrolled in other cognitive therapy that cannot be discontinued.
• Not fluent in English.
• Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation).
• Patients who receive > 5 hours of therapy from a mental health specialist during the study will not be included in the final analysis.

Where it is running

• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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