Metacognitive Training to Enhance Strategy Use in Blast-Related TBI

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

Inclusion Criteria:

- 2 incidences of blast-related mTBI according to the American Congress of
Rehabilitation Medicine, any of three following criteria:

- loss of consciousness <30 minutes, a Glasgow Coma Scale of 13

- loss of memory for events immediately before and after the event (24 hours
alteration of mental state at the time of accident)

- 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 the Test of Memory Malingering (TOMM)

- 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.