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临床试验/NCT02826785
NCT02826785已完成不适用

Feasibility and Optimization of a Cognitive Intervention for Parkinson Disease

Washington University School of Medicine0 个研究点目标入组 8 人开始时间: 2014年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
主要终点
Client Satisfaction Questionnaire

研究概览

简要总结

This study investigates the feasibility of a cognitive strategy training intervention for people with Parkinson disease (PD). We plan to recruit 8 non-demented PD participants to complete 6 weekly treatment sessions and Pre- and Post-testing (8 sessions total, entire study duration per participant = 8 weeks). We will measure participant responsiveness and the overall efficiency of the intervention process.

详细描述

Cognitive impairment is common in Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Existing rehabilitative interventions, which focus on cognitive process training, have not been successful in mitigating its negative functional consequences. We have developed a client-centered cognitive strategy training intervention to enable people with PD to work around their cognitive deficits and maintain their functional performance. This study is an exploratory case series to assess aspects of its feasibility. Specifically, we will assess participant responsiveness to the intervention (acceptance, engagement, adherence), and we will track logistical information (e.g., scheduling). We will also administer an exploratory outcome measure of treatment effect to gain preliminary evidence on the effect of the intervention on self-identified cognitive performance problems. This information will guide modifications and enhancements in preparation for future clinical trials.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females over age 50 who meet criteria for idiopathic typical PD, are Hoehn & Yahr stage I-III (mild to moderate disease; Hoehn & Yahr, 1967) and are treated with levodopa/carbidopa. For this early phase of development we will limit enrollment to people who can identify at least one daily cognitive performance problem and are willing to learn strategies to address it.

排除标准

  • Possible dementia, medication change over the study period, other neurological disorders, brain surgery (e.g., STN DBS), history of psychotic disorder or significant current psychiatric disorder (i.e., moderate to severe anxiety, apathy or depression), or any condition that would interfere with participation (e.g., non-English speaking). Participants taking benzos will be excluded.

研究组 & 干预措施

Cognitive strategy training

Experimental

The cognitive strategy training intervention consists of 6 weekly ~1 hour sessions. It is delivered in an individual, face-to-face format in the client's home. It is a behavioral intervention that teaches people metacognitive, problem-solving and other compensatory strategies to address self-identified cognitive performance problems, and it uses practice and homework to promote strategy learning, retention and transfer.

干预措施: Cognitive strategy training (Behavioral)

结局指标

主要结局

Client Satisfaction Questionnaire

时间窗: 8 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erin Foster

Assistant Professor

Washington University School of Medicine

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