NCT02048605已完成不适用
Basel Training Study II: Training of Psychosocial Skills for Patients With Parkinson's Disease
University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年2月1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
- 30
- 试验地点
- 2
- 主要终点
- Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SeiQol-DW)
研究概览
简要总结
Patients with Parkinson's disease (PD) will be trained using a cognitive behavioral group-training-program to reduce stress and augment quality of life. An unspecific group with the same amount and frequency of meetings is used as a control group. For the evaluation of the training effects, scales to assess quality of life, analyses of psychopathological variations as well as neurocognitive tests will be used. Protocol amendment in 1-2017: addition of FU year 3 and year 5.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with idiopathic Parkinson's disease according to United Kingdom Parkinson's Disease Brain Bank Criteria, being either cognitively normal, suffering from Mild Cognitive Impairment or having mild dementia. Patients must be able to give their written informed consent.
排除标准
- •Moderate or severe dementia (DMS-IV, Mini Mental Status (MMS) <24), other neurological or psychiatric diseases of the brain not related to PD, secondary parkinsonism, physical impairment hindering the adequate execution of the training, insufficient knowledge of German or pregnancy are exclusion criteria. Deep Brain Stimulation (DBS) is no exclusion criterion.
结局指标
主要结局
Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SeiQol-DW)
时间窗: Before and after 9 weeks of training, After 6-month
次要结局
- Scale for the assessment of management of daily living (Alltagsbewältigungsskala: A-B-S)(Before and after 9 weeks training, after 6 month)
研究者
研究点 (2)
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