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Metacognitive Training to Enhance Strategy Use in Blast-Related TBI

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00857207
First received: March 5, 2009
Last updated: June 20, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Brain Concussion Blast Injuries Behavioral: Goal Management Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metacognitive Training to Enhance Strategy Use in Blast Related TBI

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • computerized TOL [ Time Frame: Pre-intervention, Post-intervention and 1 month follow-up after intervention ]
    computerized Tower of London (cTOL): is a computerized program in which patients are shown two pictures simultaneously of a goal board and a test board (Unterrainer et al, 2006). Patients are instructed to determine the fewest possible moves of the balls in the test picture to make the arrangement of balls identical to that of the goal picture within 60 seconds. The screen reports whether the response is correct or incorrect. Test administration is less than 45 minutes for each session (pre/post/follow-up). Each set consists of the same number of 4, 5, 6 or 7 move problems and has the same average difficulty level. Difficulty rating is based on global and specific problem parameters shown to affect the planning process (Kaller, 2007, 2008, 2009; Berg, Byrd, McNamara, & Case, 2010; Kaller, Unterrainer, Rahm, & Halsband, 2004). The dependent variables are the total time spent solving the problem and the optimal moves made toward the goal display.


Secondary Outcome Measures:
  • BRIEF-A [ Time Frame: Pre-intervention, Post-intervention and 1 month follow-up after intervention ]
    Behavior Rating Inventory of Executive Functions-Adult (BRIEF-A) is a self and informant report questionnaire consisting of 75 statements about executive behaviors. There are three possible responses to items: often, sometimes, never. There are nine subscales: inhibit, self-monitor, plan/organize, shift initiation, task monitor, emotional control, working memory, and organization of materials. reliability in a mixed clinical sample (n=233) ranged from .80 to .94 for scales and .96 to .98 for Index and Global Executive Composite scores. Test-retest reliability over 4 weeks averaged .82 to .93 on the scales and .94 for Index and Global Executive Composite scores. The total BRIEF-A score correlates at .84 with the Dysexecutive Questionnaire (Roth, 2005). The Metacogntive Index of the score of the BRIEF-A will be used to detect a change of executive functioning in the subject's home environment.


Estimated Enrollment: 54
Actual Study Start Date: October 1, 2013
Estimated Study Completion Date: September 28, 2018
Estimated Primary Completion Date: January 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Treatment Goal Management Training
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
Control-Brain Health Workshop

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, 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.
  Contacts and Locations
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

Contacts
Contact: Julia Waid-Ebbs, PhD (352) 376-1611 waid@ufl.edu

Locations
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Recruiting
Gainesville, Florida, United States, 32608
Contact: Julia Waid-Ebbs, PhD    352-376-1611    waid@ufl.edu   
Principal Investigator: Julia Waid-Ebbs, PhD         
United States, North Carolina
Durham VA Medical Center, Durham, NC Recruiting
Durham, North Carolina, United States, 27705
Contact: Carol Smith Hammond, PhD    919-286-0411 ext 7723    Carol.SmithHammond@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Julia Waid-Ebbs, PhD North Florida/South Georgia Veterans Health System, Gainesville, FL
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00857207     History of Changes
Other Study ID Numbers: B0902-W
Study First Received: March 5, 2009
Last Updated: June 20, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Cognitive Therapy
Outcomes Assessment

Additional relevant MeSH terms:
Brain Concussion
Blast Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating
Barotrauma

ClinicalTrials.gov processed this record on August 18, 2017