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临床试验/NCT07097298
NCT07097298招募中不适用

Empathy and (Self-)Compassion to Improve the Quality of Life of Parkinson's Disease Patients and Caregivers: an Exploratory Study

Alain Kaelin1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Alain Kaelin
入组人数
30
试验地点
1
主要终点
PD patients quality of life improvement

研究概览

简要总结

The goal of this clinical trial is to improve quality of life in Parkinson's Disease (PD) patients by increasing their empathy and their (self-)compassion. The main question it aims to answer is:

Does the level of quality of life in PD patients and caregivers improve after empathy/(self-)compassion training?

Participants will be delivered a 6-week empathy and compassion training (mindfulness, writing and poetry exercises addressing the cognitive, emotional, motivational and behavioural components of (self-)compassion) and will also be asked to answer questionnaires before and after the training

研究设计

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

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of PD
  • Hoehn and Yahr scale, stage ≤ 3
  • Mini Mental State Examination with a score ≥ 26
  • Able to give informed consent as documented by signature
  • At least, secondary school education
  • To have a regular caregiver at home

排除标准

  • Any medical condition that is not PD, such as drug induced parkinsonism
  • Major depression, dysthymia, or according to DSM-V
  • Other neurological or psychiatric diseases
  • Neuropsychological scores compatible with the diagnosis of early dementia
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc
  • For CAREGIVERS:
  • Inclusion criteria
  • Taking care of the patient on a regular basis, i.e., at least 3 days per week
  • Being caregiver of the patients for at least 3 months
  • At least, secondary school education
  • Written informed consent

结局指标

主要结局

PD patients quality of life improvement

时间窗: from baseline to the end of intervention (6weeks)

the change (no min / max values foreseen) in the level of quality of life in PD patients as measured by the Parkinson's Disease Questionnaire (PDQ-8), which assesses 8 domains of quality of life: mobility, activities of daily of living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort; higher scores indicate a worse quality of life

PD patients quality of life improvement

时间窗: from baseline to the end of intervention (6weeks)

the change (no min / max values foreseen) in the level of quality of life in PD patients as measured by the Parkinson's Disease Questionnaire (PDQ-8), which assesses 8 domains of quality of life: mobility, activities of daily of living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort; higher scores indicate a worse quality of life

次要结局

  • change in the level of empathy in PD patients and caregivers(from baseline to the end of intervention (6weeks))
  • self-compassion level change in PD patients and caregivers(from baseline to the end of intervention (6weeks))
  • compassion level change in PD patients and caregivers(from baseline to the end of intervention (6weeks))
  • quality of life level change in caregivers(from baseline to the end of intervention (6weeks))

研究者

发起方
Alain Kaelin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alain Kaelin

Prof. MD PhD

Ente Ospedaliero Cantonale, Bellinzona

研究点 (1)

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