Effectiveness of Combined Attention and Metacognitive-strategy Training Approaches to Cognitive Impairment in Moderate-to-severe TBI
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Measurement of change in self-care
研究概览
简要总结
The purpose of this research study is to develop a method to improve thinking difficulties in individuals who have experienced a traumatic brain injury and report experiencing difficulties in attention and concentration. This study aims to understand how cognitive rehabilitation of attention difficulties affects brain activity.
详细描述
This study will compare the effectiveness of two different types of cognitive rehabilitation in moderate-to-severe (m/s) traumatic brain injury (TBI) survivors. More specifically comparisons will be made between Direct Attention Training administered via BrainHQ, and Metacognitive Strategy Training in the form of the evidence-based Goal Management Training (GMT) protocol.
These interventions will be compared to the standard of care, to each other, and their combined effectiveness will be assessed. Groups will consist of randomized individuals with moderate-to-severe TBIs who experience attention deficits. Each treatment will be administered for 4 weeks and two intervention groups will be used to counterbalance treatment order. Group 1 will receive BrainHQ first followed by GMT, while Group 2 will receive GMT first followed by BrainHQ. In addition a third group will serve as a treatment-as-usual control group.
Primary outcomes include measures of self-care, ability, adjustment and participation. Secondary outcomes include measures of cognition and brain function. And lastly, tertiary outcomes include measures of emotional and psychosocial functioning. These outcomes will be measures at baseline, following completion of the first 4 week treatment in both groups (Group 1 = BrainHQ while Group 2 = GMT), and following completion of the second 4 week treatment in both groups (Group 1 = GMT while Group 2 = BrainHQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-report of attention problems, confirmed with psychometric testing
- •Ruff 2 & 7 selective attention task score ≤ 1.5 standard deviations from demographically-matched norms
- •Able to participate in study at 12-60 months post-injury without contraindications
- •Willingness to be randomized and to participate in treatment procedures
- •Capacity to visit the laboratory for repeated treatment sessions and testing
- •Access to internet-enabled home computer
- •English as native language
- •Adequate reading comprehension to allow completion of questionnaires
- •Reliable digit span (RDS) score > 7
排除标准
- •Pre-existing neurological disorder associated with cerebral dysfunction (e.g., stroke, history of epilepsy or chronic seizure disorder)
- •Current alcohol or drug use
- •Pre-existing severe psychiatric disorder (e.g., schizophrenia) detected by Mental Screening form, 3rd edition (MHS-III) or history of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization
- •Current suicidal/homicidal ideation or intent
- •Reported involvement in current litigation
- •Reported history of pre-injury learning disability
- •Not competent to provide written informed consent (i.e., not able to demonstrate understanding or expectations of study and potential risks of participation)
- •Does not fully understand the nature of the study and requirements of participation
- •Does not understand task instructions
- •Validity testing (score ≤ 7) on the RDS 22 test of suboptimal/non-credible performance taken from the forward and backward digit span subtests of the WAIS-IV
结局指标
主要结局
Measurement of change in self-care
时间窗: Measured at Baseline, Post treatment 1 (4 weeks post-baseline), Post treatment 2 (8 weeks post baseline)
These will be measured via the Timed Instrumental Activities of Daily Living assessment. Participants will be timed performing common functional tasks and longer completion times indicate greater impairment.
Measurement of change in ability, adjustment and participation
时间窗: Measured at Baseline, Post treatment 1 (4 weeks post-baseline), Post treatment 2 (8 weeks post baseline)
A composite self-report questionnaire known as the Mayo-Portland Adaptability Inventory will be used to measure functioning across these domains. This measures uses a scale from 0 to 4. The higher the score the more severe the impairment.
次要结局
未报告次要终点