A Pilot Feasibility Study of a Co-constructed Program (Patients - Experts) of Mindfulness Meditation Adapted to Patients With Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Assess MBSR program
研究概览
简要总结
The objective of this study is to determine the feasibility (primary objective) and the effects (secondary objectives) of an Mindfulness Based Stress Reduction (MBSR) program adapted specifically for patients with Parkinson's disease.
详细描述
In Parkinson's disease (PD) the psychological distress (anxiety and depression), is particularly impacting and often resistant to conventional drug treatment explaining the growing interest of patients in non-drug methods, such as mindfulness meditation. The Mindfulness Based Stress Reduction (MBSR) program has been evaluated in Parkinson's disease, showing main effects on anxiety and depression symptoms. These data remain, however, still fragile, particularly in terms of methodological robustness and number of patients involved and variable size of effects. A clinical trial was recently conducted at the Bordeaux University Hospital with 28 patients with Parkinson's disease . Preliminary results suggest that a program tailored specifically to the expectations and needs of patients with Parkinson's disease could, optimize accessibility, acceptability, and patient compliance for this type of approach while preserving clinical efficacy on anxiety and depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from Parkinson's disease,
- •Patient aged over 18 and under 80,
- •Patient with a Hoehn and Yahr Stage of 1 to 3,
- •Patient affiliated or beneficiary of the social security system,
- •Patient having signed a free, informed and written consent
排除标准
- •Patient with severe motor fluctuations (i.e. scoring 4 to at least one of the following items of part IV of the Movement Disorder Society Unified Parkinson Disease Rating Scale: 4.1 and 4.2 for dyskinesias; 4.3, 4.4 and 4.5 for motor fluctuations),
- •Patient with acute depression not stabilized by treatment or dating from less than 6 months,
- •Patient with non-stabilized psycho-behavioral disorders (hallucinations, psychoses, impulse control disorders) dating from less than 6 months,
- •Patient with major cognitive impairment (Montreal Cognitive Assessment ≤24),
- •Patient who has already participated in a structured mindfulness meditation program
- •Patient placed under judicial safeguard, guardianship or curator ship,
- •Pregnant or breastfeeding women.
研究组 & 干预措施
MBSR program adapted
8 week program with weekly sessions of 2h30 and a full day of practice designed from the analysis of the post-program interviews
干预措施: Mindfulness Based Stress Reduction (Procedure)
结局指标
主要结局
Assess MBSR program
时间窗: Month 4
The rate of patients who have completed the entire MBSR program "adapted"
次要结局
- King's college Parkinson's disease Pain Scale(Day 0 and month 3)
- Number of Anti-parkinsonian and psychotropic treatments(Day 0 and month 3)
- Attendance rate(Month 3)
- Beck Depression Inventory(Day 0 and month 3)
- Parkinson Disease Questionnaire(Day 0 and month 3)
- Movement Disorder Society Unified Parkinson Disease Rating Scale(Day 0 and month 3)
- Relevance of the adaptations put in place(month 3)
- Program tolerance(month 1 at month 2)
- Parkinson Anxiety Scale (PAS)(Day 0 and month 3)
- Parkinson's Disease Sleep Scale(Day 0 and month 3)