The Effect of Goal Management Training With Mild Traumatic Brain Injured Veterans; Metacognitive Training to Enhance Strategy Use in Blast-Related TBI
Verified July 2014 by Department of Veterans Affairs
Information provided by (Responsible Party):
Department of Veterans Affairs
First received: March 5, 2009
Last updated: July 18, 2014
Last verified: July 2014
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
||The Effect of Goal Management Training With Mild TBI Veterans
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
Assessment for 10 sessions prior to start of group therapy (A of AB design)
Behavioral: Goal Management Training
Goal Management Training is a 7-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks.
No Intervention: Arm 2
|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 either the Test of Memory Malingering (TOMM), and the Minnesota Multiphasic Personality Inventory-version 2-Restructured Form MMPI-2-RF).Score of 45 or less on TOMM Trial 2 or retention trial. Two scores of 80T on Variable Response Inconsistency, True Response Inconsistency, or F-family indicators.
- 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, Florida, United States, 32608 |
|Contact: Julia Waid-Ebbs, PhD 352-376-1611 firstname.lastname@example.org |
|Principal Investigator: Julia Waid-Ebbs, PhD |
|James A. Haley Veterans' Hospital, Tampa, FL
|Tampa, Florida, United States, 33612 |
|Contact: Erline V Nakono, CCC/SLP 813-972-2000 ext 4844 Erline.Nakano@va.gov |
||Julia Waid-Ebbs, PhD
||North Florida/South Georgia Veterans Health System
No publications provided
||Department of Veterans Affairs
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 5, 2009
||July 18, 2014
||United States: Federal Government
Keywords provided by Department of Veterans Affairs:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries