Improving Time-Based Prospective Memory in TBI: A Feasibility and Dosing Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Recruitment rate percentage
研究概览
简要总结
This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI).
详细描述
This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI), particularly improving the ability to remember to do things in the future.
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
- Double (Care Provider, Investigator)
盲法说明
Study staff conducting baseline and follow-up assessments will be blind as to which group participants are placed. Study staff conducting intervention sessions will be blind to participants' baseline and follow-up assessment performance.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sustained a moderate-to-severe TBI at least one year prior to assessment
- •Fluent in English
- •Demonstrate impairment in strategic cognitive abilities
排除标准
- •Significant neurological history other than TBI
- •Significant psychiatric history (e.g., bipolar disorder, schizophrenia)
- •Significant substance abuse history
- •Steroid and/or benzodiazepine use
研究组 & 干预措施
Experimental
The experimental group will receive treatment program designed to train strategic cognitive functions. Sessions will last 50 minutes and take place twice per week for 16 weeks.
干预措施: computer-based cognitive rehabilitation (CBCR) (Behavioral)
Control group
The control group will receive no active treatment and will be treated as a "no-contact control" group.
结局指标
主要结局
Recruitment rate percentage
时间窗: phone screen to in-person screen (within 2 weeks)
percentage of interested participants who met eligibility criteria via phone screen are eligible at in person screen
Intervention Tolerability Assessment Scale
时间窗: baseline through final follow-up assessment (16 weeks)
visual analog scale to assess participants' tolerability of intervention
Retention rate percentage
时间窗: baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)
adherence rate to treatment sessions within 8 weeks (i.e., attendance at 16 sessions), 12 weeks (24 sessions), and 16 weeks (32 sessions)
次要结局
- Changes in strategic cognitive functions (performance on NIH EXAMINER)(16 weeks)
- Changes in time monitoring & time-based prospective memory(16 weeks)
研究者
Erica Weber
Research Scientist
Kessler Foundation