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临床试验/NCT04560946
NCT04560946已完成不适用

Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans with a History of TBI

Veterans Medical Research Foundation4 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2019年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
4
主要终点
Change in the Neurobehavioral Symptom Inventory (NSI)

研究概览

简要总结

Mild traumatic brain injury (TBI) is a common medical condition that occurs when a head injury causes someone to lose consciousness, feel dazed or confused, or be unable to remember events occurring immediately after the injury. While most individuals with mild TBI recover within weeks or months, some individuals with mild TBI report chronic symptoms such as difficulty with cognitive skills like attention, learning, or memory, along with other symptoms such as irritability or headache. Previous studies, including those conducted by our scientific team, have shown that cognitive rehabilitation can help patients with persistent symptoms after mild TBI return to full duty, work, school, and other important life activities. Specifically, cognitive rehabilitation can provide lasting improvements in thinking abilities, functional capacity, post-concussive symptoms, and quality of life after mild TBI. However, effective interventions are still out of reach for many service members and Veterans with TBI. For patients who have returned to duty, employment, or education, scheduling up to 60 hours of treatment (a typical treatment schedule in many settings) may not be feasible. Additionally, some patients may live in areas where it is burdensome to make numerous visits to a medical center. Personalized Augmented Cognitive Training (PACT) compresses treatment into six hours of once-weekly personalized, one-on-one training by selecting treatment modules based on patient needs and priorities-substantially reducing the total amount of time required to complete treatment. PACT can be offered either in-person (in clinic) or via home-based video telemedicine, depending upon patients' preferences. Additionally, PACT includes training and encouragement for service members and Veterans to make self-directed use of mobile apps that train cognitive skills and strategies.The primary goal of this study is to evaluate whether PACT is effective at improving cognition, symptoms, and functional outcomes among military service members and Veterans with a history of mild TBI. The study will also yield information about factors that can enhance or interfere with treatment, such as number of previous TBIs, presence of post-traumatic stress; and choice of in-person vs. video telemedicine delivery of care.

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
Single (Outcomes Assessor)

盲法说明

Outcomes assessors will be blind to treatment group assignment.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All participants:
  • Male or female
  • All racial and ethnic groups
  • Ages 18 to 55
  • Veteran or service member
  • History of mild TBI (as defined by the DoD/VA criteria used in conjunction with the OSU TBIID method)
  • Score of ≥4 on the cognitive subscale of the Neurobehavioral Symptom Inventory reflecting 'very severe' symptoms in at least one area or at least 'mild' symptoms in all four areas surveyed
  • have a compatible device (computer, tablet, or smartphone) with internet connection (wifi or cellular plan).

排除标准

  • Mild TBI sustained < 3 months previously
  • History of moderate, severe, or penetrating TBI
  • History of other neurological condition unrelated to TBI
  • Current psychiatric disturbance that would preclude study participation (e.g. clinically significant mania or psychosis)
  • Current substance use disorder
  • Current, active suicidal or homicidal ideation
  • Current use of benzodiazepines or medications with anticholinergic effects
  • Not stable on psychiatric medications for at least 6 weeks
  • Impaired decision making capacity
  • Unable to provide voluntary informed consent
  • Previously completed >4 sessions of cognitive rehabilitation

结局指标

主要结局

Change in the Neurobehavioral Symptom Inventory (NSI)

时间窗: 6, 12 weeks

Measure of post concussive symptoms

次要结局

  • Change in UCSD Performance-Based Skills Assessment-B (UPSA-B)(6, 12 weeks)
  • Change in WMS-IV Digit Span(6, 12 weeks)
  • Change in California Verbal Learning Test-III (CVLT-III)(6, 12 weeks)
  • Change in D-KEFS Verbal Fluency(6, 12 weeks)
  • Change in Oral Trails(6, 12 weeks)
  • Change in Test My Brain Continuous Performance Test(6, 12 weeks)
  • Change in Test My Brain Matrix Reasoning(6, 12 weeks)
  • Change in Test My Brain Digit Symbol Matching(6, 12 weeks)
  • Change in Test My Brain Choice Reaction Time(6, 12 weeks)
  • Change in the Pittsburgh Sleep Quality Index (PSQI)(6, 12 weeks)
  • Change in Cognitive Problems and Strategies Assessment(6, 12 weeks)
  • Change in Patient Global Impression of Change (PGIC)(6, 12 weeks)
  • Change in Traumatic Brain Injury Quality of Life (TBI-QoL)(6, 12 weeks)
  • Change in WHO Disability Assessment Schedule (WHODAS) 2.0 (plus supplementary questions for duty status, work/school)(6, 12 weeks)

研究者

发起方
Veterans Medical Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (4)

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