Clinical trial NCT00857207: Metacognitive Training to Enhance Strategy Use in Blast-Related TBI
Official title: Metacognitive Training to Enhance Strategy Use in Blast Related TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Blast Injuries
Keywords: Cognitive Therapy
Outcomes Assessment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-03-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility criteria: 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.

Primary outcomes:
measure: Computerized Tower Of London (cTOL)
timeFrame: Baseline, 10 weeks
Secondary outcomes:
measure: BRIEF-A
timeFrame: Baseline, 10 weeks
measure: cTOL Optimal Moves
timeFrame: baseline, 10 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: Julia K. Waid-Ebbs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waid-Ebbs JK; BCBA-D; Daly J, Wu SS, Berg WK, Bauer RM, Perlstein WM, Crosson B. Response to goal management training in veterans with blast-related mild traumatic brain injury. J Rehabil Res Dev. 2014;51(10):1555-66. doi: 10.1682/JRRD.2013.12.0266.