NCT02922569已完成不适用
Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Changes in performance on global cognitive composite score
研究概览
简要总结
This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the safety and efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.
详细描述
The primary objective of this study is to evaluate the effects of combination of mindfulness training (MT) and adaptive cognitive training (CT) on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with traumatic brain injury (TBI, also referred to as a concussion, or blast exposure), as compared to a computer-based control.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be 18 years of age or older
- •Participants must have diagnosis of mild traumatic brain injury (mTBI) confirmed by Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF)
- •Participants must have persistent cognitive dysfunction confirmed by an objective measure (Automated Neuropsychological Assessment Metrics (ANAM) TBI Battery with a score at least one standard deviation below the age-adjusted norm for a military sample) or a subjective measure (Ruff Neurobehavioral Inventory (RNBI) with a score of greater than 70 on any of the four cognitive scales (Attention, Memory, Language, Executive)
- •Participants must be at least six months out from their most recent traumatic brain injury (TBI), concussion, and/or blast exposure
- •Participant must be a fluent English speaker
- •Participants must score ≥ 70 on the Wechsler Test of Adult Reading (WTAR)
- •Participants must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse
排除标准
- •Participants with history of TBI with loss of consciousness for more than 24 hours or post-traumatic amnesia for more than 7 days
- •Participants with a history of penetrating head wounds
- •Participants who are in-patients
- •Participants with a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis)
- •Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Participants showing signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit
- •Participants with clinically significant visual field deficits
- •Participants judged to be lacking effort
- •Participants with problems performing assessments or comprehending or following spoken instructions
- •Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment for TBI that could affect the outcome of this study
- •Participant with self-reported claustrophobia or physician-reported implanted devices (e.g. pacemakers, cochlear implants, aneurysm clips, etc.) and pregnant women will not be able to participate in MRI portion of study.
结局指标
主要结局
Changes in performance on global cognitive composite score
时间窗: At 3 months and at 6 months
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.
次要结局
- Changes in performance on memory composite score(At 3 months and at 6 months)
- Change in functional performance(At 3 months and at 6 months)
- Changes in brain function(At 3 months)
- Changes in brain structure(At 3 months)
- Changes in performance on processing speed composite score(At 3 months and at 6 months)
- Changes in performance on executive function composite score(At 3 months and at 6 months)
- Changes in task-related brain activation(At 3 months)
- Change in TBI functional status(At 3 months and at 6 months)
研究者
研究点 (2)
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