Metacognitive Training to Enhance Strategy Use in Blast-Related TBI
Verified August 2015 by Department of Veterans Affairs
Information provided by (Responsible Party):
Department of Veterans Affairs
First received: March 5, 2009
Last updated: August 6, 2015
Last verified: August 2015
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.
Behavioral: Goal Management Training
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Metacognitive Training to Enhance Strategy Use in Blast Related TBI
Primary Outcome Measures:
- computerized TOL, BRIEF-A, Dkefs [ Time Frame: Pre, Post and 1 month follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2018 (Final data collection date for primary outcome measure)
Experimental: Arm 1
Treatment Goal Management Training
Behavioral: Goal Management Training
Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks.
No Intervention: Arm 2
Control-Brain Health Workshop
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 2 incidences of blast-related mTBI according to the American Congress of Rehabilitation Medicine, any of three following criteria: 1) loss of consciousness <30 minutes, a Glasgow Coma Scale of 13; 2) loss of memory for events immediately before and after the event ( 24 hours); alteration of mental state at the time of accident; 3) 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857207
|North Florida/South Georgia Veterans Health System, Gainesville, FL
|Gainesville, Florida, United States, 32608 |
|Contact: Julia Waid-Ebbs, PhD 352-376-1611 firstname.lastname@example.org |
|Principal Investigator: Julia Waid-Ebbs, PhD |
||Julia Waid-Ebbs, PhD
||North Florida/South Georgia Veterans Health System, Gainesville, FL
||Department of Veterans Affairs
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 5, 2009
||August 6, 2015
||United States: Federal Government
Keywords provided by Department of Veterans Affairs:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2015
Central Nervous System Diseases
Head Injuries, Closed
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries