Mindfulness Meditation (MBSR) and Parkinson's Disease (PD)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Non-pharmacological therapies become more important in the management of Parkinson's disease
      (PD). Among these, mindfulness meditation is the subject of high expectations. This
      intervention, such as the Mindfulness-Based Stress Reduction-based (MBSR) stress reduction
      program, have shown effects on psychological distress, motor and non-motor disorders, and
      quality of life. However, the data is still very frail and the conditions for practical use
      are still very uncertain. The objective of the study is to determine the feasibility of a
      standardized MBSR program in Parkinsonians patients.
    

Detailed description: 
      Recent interest has developed in non-drug methods in the management of PD, especially for
      non-motor signs since recent years. Numerous studies have been investigated this issue,
      particularly in regard to mindfulness meditation approaches. Nowadays, the mindfulness-based
      stress reduction program (MBSR) is the most studied in medicine ([18]). The MBSR program has
      been studied in Parkinson's disease in numerous studies ([24], [3], [1], [9]) and the program
      compliance is reported as variable,from high (80%, [24], [9]) to modest (50%,; [3]), with
      little data on acceptability. Mindfulness meditation in the management of Parkinson's disease
      is the subject of high expectations for patients and their caregivers but the scientific
      literature is still very frail and the conditions for practical use in our country remains
      still very uncertain. What is the feasibility and acceptability of a standard MBSR-type
      program? For which type of patients? For which symptom (s)? What are the benefits,
      constraints and / or adverse effects felt? If a nationwide interventional trial were to be
      proposed, what would be the primary objective? What would be the ideal design? The MBSR
      program is a standardized group program (10 to 20 people) over 8 weeks. The program is
      progressive and structured, essentially practical, participatory and interactive, encouraging
      and supportive. The MBSR program will be supplemented by two visits (1 month before and 1
      month later) including: a global clinical evaluation (MDS-UPDRS), a cognitive evaluation
      (MOCA and TAP battery), depression (BDI-II) and anxiety scales (PAS, self-questionnaire),
      sleep (Pittsburgh Sleep Quality Index), pain (EVA) and quality of life (PDQ-39). In addition,
      a qualitative interview on the expectations of the program will be carried during the
      pre-program interview and a qualitative descriptive evaluation on the acceptability, the
      adverse effects and the feeling of the program during the post-program interview.
    

Intervention name(s): Mindfulness-Based Stress Reduction-based program (MBSR).
Intervention type(s): Behavioral
Intervention description(s): The MBSR program is built over 8 weeks (1 information session, 8 group sessions from 2h30 to 3h and 1 full day). A trained MBSR instructor will lead group sessions weekly for approximately 150-210 minutes to teach and demonstrate the practices. Practices include walking/standing/supine meditation, body scanning (drawing attention to various areas of the body such as the right foot or left hand), and simple hatha yoga postures. Exercises are the basis of this group learning with practice time and practice exchange time. Participants are asked to commit to daily meditation at home using audioguides for 40 minutes to 1 hour.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective exploratory monocentric pilot study in the context of interventional research with minimal risks and constraints, which aims to collect qualitative and quantitative data from two pilot 8-week MBSR programs organized at the University Hospital Center. Bordeaux with two groups of patients: 10 non-fluctuating patients or with minor fluctuations (Group A) and 10 patients with mild to moderate fluctuations (Group B).
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Parkinson; MBSR; Mindfulness