Status:
COMPLETED
Metacognitive Training to Enhance Strategy Use in Blast-Related TBI
Lead Sponsor:
VA Office of Research and Development
Conditions:
Brain Concussion
Blast Injuries
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief 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 th...
Detailed Description
OBJECTIVES: Aim 1: is to test benefits of GMT for improving executive function. Aim 2: Investigate factors which affect response to treatment. RESEARCH PLAN: This is a randomized controlled study t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2019
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00857207
Start Date
October 1 2013
End Date
December 23 2019
Last Update
March 30 2021
Active Locations (1)
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1
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608