Metacognitive Training to Enhance Strategy Use in Blast-Related TBI
Condition: Brain Concussion; Blast Injuries
MeSH terms: Brain Concussion; Blast Injuries
Study type: Interventional

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 description: 
      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.

      Participants will be randomly assigned to either treatment or control groups, in a ratio of
      38:16. In addition, the Pocock-Simon covariate adaptive randomization procedure will be used
      so that, for each PTSD severity category within each of the two sites, approximately 70%
      (38/54) of subjects are assigned to treatment group; consequently, there will be
      approximately equal proportion of PTSD subjects assigned to the treatment and control groups
      within each of the two study sites.

      Simulated Practice In The Laboratory: Training tasks include exercises such as: 1) clapping
      to words and inhibiting clapping to a targeted word; 2) card sorting; 3) decision making and
      planning in order to complete five activities within a four minute time span; 4) Catalog
      Task; and 5) Book keeping task. Initially, the exercises are relatively easy and subsequently
      progress to greater complexity. Participant's strengths and weaknesses are discussed.
      Improvements are identified and reinforced as they learn more efficient planning and problem
      solving. The following steps are taught during simulated tasks: 1) Identify Main Goal; 2)
      Break down task into sub-goals and steps for each goal; 3) List supplies needed; 4) Recognize
      potential barriers to completing goal; 5) Determine strategy to accomplish task: 6) Prepare
      to begin task with "presence of mind" exercise; 7) State goal out loud; 8) Begin task and
      stop self frequently to state main goal out loud and check to be sure one is working toward
      the goal (on target).

      Functional Practice at Home and with Smartphone Technology: In addition to lab practice, the
      original GMT (Levine, 2000)includes three tasks that must be practiced at home. Participants
      identify a complex task with which they are having difficulty, for example, meal planning and
      shopping; planning a party; building a birdhouse; or paying monthly bills. Generalization of
      laboratory practice to home environment is of critical importance. Unfortunately, the
      original GMT did not provide a method to monitor the frequency or success of home practice,
      nor a method to support productive practice in the home environment. In prior work, the
      investigators developed The Veteran's Task Manager (A Smartphone application (AP).
      Participants will use the AP features to break down tasks, estimate time to complete, check
      off each step as completed, respond to the visual/vibrating alert of "Goal" and respond to
      alert if "On Target". Information will be collected by the AP, such as accuracy of planned
      steps, time to complete task, and number of distractions from goal. The AP will record the
      participant's performance in functional practice at home and this information will be
      reviewed at the next lab session.

      Control Group Intervention. The Brain Health Workshop (BHW; Levine 2011) was developed
      specifically for consistency with GMT session length and contact with the facilitator
      (Levine, 2011). BHW is an education presentation on brain function and cognitive principles
      of learning. Information about stress reduction, sleep hygiene, energy management, exercise
      and communication are covered with homework and quizzes on information covered.

      FINDINGS: Initial report
    

Intervention name(s): Goal Management Training
Intervention type(s): Behavioral
Intervention description(s): Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Therapy; Outcomes Assessment