The Effect of Goal Management Training With Mild Traumatic Brain Injured Veterans; Metacognitive Training to Enhance Strategy Use in Blast-Related TBI

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00857207
First received: March 5, 2009
Last updated: July 18, 2014
Last verified: July 2014
  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 Phase
Brain Concussion
Behavioral: Goal Management Training
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Goal Management Training With Mild TBI Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • computerized TOL, BRIEF-A, Dkefs [ Time Frame: Pre, Post and 1 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: June 2009
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Wait group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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: 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.

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 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.
  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 Recruiting
Gainesville, Florida, United States, 32608
Contact: Julia Waid-Ebbs, PhD    352-376-1611    waid@ufl.edu   
Principal Investigator: Julia Waid-Ebbs, PhD         
James A. Haley Veterans' Hospital, Tampa, FL Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Erline V Nakono, CCC/SLP    813-972-2000 ext 4844    Erline.Nakano@va.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Julia Waid-Ebbs, PhD North Florida/South Georgia Veterans Health System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00857207     History of Changes
Other Study ID Numbers: B6700-M
Study First Received: March 5, 2009
Last Updated: July 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cognitive Therapy
Outcomes Assessment

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

ClinicalTrials.gov processed this record on October 19, 2014