Randomized Controlled Expressive Writing Pilot in Individuals With Parkinson's Disease and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Parkinson's Disease Quality of Life (PDQ-39)
研究概览
简要总结
This randomized, controlled trial (RCT) evaluates the benefits of expressive compared to neutral writing in individuals with Parkinson's Disease and their support persons. Participants will be randomly assigned to complete three, 20 minute sessions of expressive or neutral writing. Participants will complete evaluation of outcomes at baseline, immediate post, 4 month and 10 month follow ups to establish if benefits remain over time. Impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. Expressive writing is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the neutral writing condition.
Results from this study will determine whether brief writing exercises are easily used by and beneficial for individuals with Parkinson's Disease and their support persons. If positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with Parkinson's Disease and their support persons.
详细描述
The expressive writing condition asks participants to write about the most stressful or traumatic experience of their entire lives over three, 20 minute private writing sessions. The neutral control writing conditions asks participants to write about how they spent their time the day before.
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
- None
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
- •Clinical diagnosis of Parkinson's Disease Caregiver of an individual with Parkinson's Disease
排除标准
- •Clinical diagnosis of Dementia Clinical diagnosis of other Parkinson's Disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing
研究组 & 干预措施
Writing Intervention - Expressive Arm
Participants are asked to write about the most traumatic or stressful experience of their entire lives in three, 20 minute writing sessions.
干预措施: Writing Intervention (Behavioral)
Writing Intervention - Neutral Arm
Participants are asked to write about what they did the day before, refraining from including emotional details.
干预措施: Writing Intervention (Behavioral)
结局指标
主要结局
Parkinson's Disease Quality of Life (PDQ-39)
时间窗: Baseline to immediate post
次要结局
- Parkinson's Disease Quality of Life Questionnaire (PDQ-39)(4 month follow up to 10 month follow up)
- Parkinson's Disease Quality of Life Questionnaire (PDQ-39)(Immediate post to 4-month follow up)