Clinical Trial: Metacognitive Training to Enhance Strategy Use in Blast-Related TBI
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Metacognitive Training to Enhance Strategy Use in Blast Related TBI
Brief Summary: 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.
Detailed Summary:
OBJECTIVES:
Aim 1: is to test benefits of GMT for improving executive function. Aim 2: Investigate factors which affect response to treatment.
RESEARCH PLAN:
This is a randomized controlled study to investigate the effect of Goal Management Training (GMT) for those with blast-related mTBI. The control group will participate in the Brain Health Workshop (BHW; Levine 2011), developed specifically for consistency with GMT session length and contact with the facilitator (Levine, 2011). Study outcome measures will be collected at pre- and post-treatment, and at 1 month after the end of treatment.
Family Member/Friend of Participant. The participant will identify a friend or family member who observes his/her everyday behavior at least 2-3 hours, twice a week. After obtaining the consent of the person, both the participant and his/her friend or family member(s) will attend a general education session about brain function and treatments. In addition to attending the education session the consenting friend or family member will answer a questionnaire (BRIEF-A) about the participant's executive function. The friend or family member will also receive phone calls weekly in order to report the participant's ease or difficulties in completing homework.
METHODS:
The investigators will enroll 54 participants, recruited from the North Florida/South Georgia Veteran Health System in Gainesville. Clinical staff will inform outpatients about the study. Patients interested in hearing more about the research study will be provided with contact information for the study staff. A meeting will be scheduled and candidates will be screened.
Sponsor: VA Office of Research and Development
Current Primary Outcome: computerized TOL, BRIEF-A, Dkefs [ Time Frame: Pre, Post and 1 month follow-up ]
Original Primary Outcome: Simulated Tasks, BRIEF-A, Dkefs [ Time Frame: Pre, Post and 1 month follow-up ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: VA Office of Research and Development
Dates:
Date Received: March 5, 2009
Date Started: October 2013
Date Completion: September 2018
Last Updated: November 30, 2016
Last Verified: November 2016
