Trial record 8 of 48 for:    "Brain Concussion"

The Effect of Goal Management Training With Mild Traumatic Brain Injured Veterans

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00857207
First received: March 5, 2009
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

Goal Management Training is a 7-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks. This research study will test the effect of the training on 40 OEF/OIF veterans. 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: 40
Study Start Date: June 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Detailed Description:

OBJECTIVES:

Specific Aim 1: to determine if, within individual subjects, there is an effect of the GMT treatment upon performance.

Specific Aim 2: to determine an effect size and perform a power analysis for future studies.

RESEARCH PLAN:

To determine the effect of GMT on veterans with mTBI the following research will be conducted. OEF/OIF veterans diagnosed with mTBI from the NF/SG VHS that are interested in participating in research will be screened to determine whether they meet the inclusion/exclusion criteria. Veterans that meet inclusion criteria will complete the treatment and control probes on a weekly basis for at least 8 weeks and stability is obtained. Once stability in baseline is reached the veterans will begin treatment. Each veteran will continue the treatment and control probes after each weekly session of GMT and at a one month follow-up after the conclusion of treatment. In addition to repeated measures after each session, a measure of generalization will be administered prior to GMT, after GMT and the one month follow-up after conclusion of treatment.

METHODS:

Forty veterans diagnosed with blast-related mild TBI will be enrolled in a group cognitive therapy called Goal Management Training (GMT). GMT is a 7-session (2 hours/ session) interactive Power Point module that is presented in a group format. During each session, a 5-stage strategy is taught to the participants. The 5-stage process consists of "stop-what am I doing?", "define the goal", "list the steps", "learn the steps" then "check-am I doing what I planned". The strategy is then incorporated into tasks practiced in the group session as well as in tasks each participant is to practice at home. The participants discuss utilization of the strategies and support the other members in the group. Family members will participate in a training session prior to beginning GMT with the subject. The family members will be instructed on homework the subject will be practicing at home between sessions. The family member will be asked to report on subject's experience with homework assignments each week.

The subject will be incorporated into a therapy session with 3 other participants (either other clinical patients or research participants diagnosed with TBI). During the GMT, the participants will be taught the 5-step strategy using a Power Point presentation. The participants will practice the strategy during the sessions using paper and pencil tasks. Participants will be assigned home work during the week before the next session. Home work will consist of implementation of the strategies at home and at work. The participants will discuss the use of the strategies at the next session.

FINDINGS: Initial report

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Mild TBI according to the American Congress of Rehabilitation Medicine; any of three following criteria are met: 1) loss of consciousness less than 30 minutes with a Glasgow Coma Scale of 13 or above; 2) any loss of memory for events immediately before and after the event (not longer than 24 hours); any alteration of mental state at the time of accident; 3) any focal neurological deficits that may, or may not, be transient (ACRM, 1993). The injury must also have been witnessed by another person and documented in the medical record.
  • Executive dysfunction determined by at least one standard deviation below the average scaled score (corrected for age, sex and educational level) on one or more of the Delis-Kaplan Executive function System (D-Kefs) principal scores.
  • Age 18 to 55 years
  • At least 4 months post injury
  • Family member or friend that is willing to provide feedback

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 (NART)
  • Score of 45 or less on Test of Memory Malingering (TOMM) Trial 2 or retention trial.
  • Reported alcohol or substance abuse within the past year
  • Reported involvement in current litigation
  • Recent change of medications for seizures, depression or memory.
  • Currently enrolled in other cognitive therapy that cannot be discontinued
  • Does not speak English fluently
  • Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857207

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
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: January 13, 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 April 16, 2014