Metacognitive Training to Enhance Strategy Use in Blast Related TBI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Computerized Tower Of London (cTOL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Computerized Tower Of London (cTOL)
时间窗: Baseline, 10 weeks
a computerized program in which patients are shown two pictures simultaneously of a goal board and a test board and are instructed to use the fewest possible moves to match the two boards within 60 seconds. Each baseline and 10 week set of 30 problems consists of the same number of 4, 5, 6 or 7 move problems and has the same average difficulty level. The dependent variables are the total time spent solving the problem (0-60 seconds for each problem; less time is better) and the proportion of optimal moves (toward the goal 0-1 with 1 being the best outcome) and time to first move (0-60 seconds with more planning time indicating better outcome).
次要结局
- BRIEF-A(Baseline, 10 weeks)
- cTOL Optimal Moves(baseline, 10 weeks)