The Effect of Goal Management Training With Mild Traumatic Brain Injured Veterans
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.
|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|
- computerized TOL, BRIEF-A, Dkefs [ Time Frame: Pre, Post and 1 month follow-up ] [ Designated as safety issue: No ]
|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)|
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
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.
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.
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
|United States, Florida|
|North Florida/South Georgia Veterans Health System|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Julia Waid-Ebbs, PhD||North Florida/South Georgia Veterans Health System|