Feasibility of an Adapted Mindfulness Program to Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Feasibility Study of a Co-constructed Program (Patients - Experts) of Mindfulness Meditation Adapted to Patients With Parkinson's Disease.

Conditions
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Parkinson Disease

Intervention / Treatment
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* Procedure: Mindfulness Based Stress Reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR program adapted<br>8 week program with weekly sessions of 2h30 and a full day of practice designed from the analysis of the post-program interviews | Procedure: Mindfulness Based Stress Reduction<br>* Inspired by the standard Mindfulness Based Stress Reductio program, the study MAdaPARK is a 8 week program with weekly sessions of 2h30 and a full day of practice designed from the analysis of the post-program interviews carried out as part of the M-PARK study,as well as the reflections of the working group specially set up for this purpose. Several areas of adaptation have been identified: shorter mediations, a break time during the sessions, more times for exchanges, a more developed practice in movement, and finally, more important work based on self-esteem and self-compassion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess MBSR program | The rate of patients who have completed the entire MBSR program adapted | Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance rate | Number of days of practice and daily meditation time. | Month 3 | 
| Program tolerance | Number of side effects and the difficulties | month 1 at month 2 | 
| Relevance of the adaptations put in place | It will be evaluated from the analysis of feelings and impressions of patients . These different elements will be obtained from the analysis of the semi-directed interviews (qualitative analysis). | month 3 | 
| Beck Depression Inventory | Assessment depressive symptoms, minimum value 0 and maximum value 36 | Day 0 and month 3 | 
| Parkinson Anxiety Scale (PAS) | Assessment anxiety symptoms,minimum value 0 and maximum value 48 | Day 0 and month 3 | 
| Parkinson's Disease Sleep Scale | Assessment sleep, minimum value 0 and maximum value 60 | Day 0 and month 3 | 
| Parkinson Disease Questionnaire | Assessment quality of life, minimum value 0 and maximum value 156 | Day 0 and month 3 | 
| Movement Disorder Society Unified Parkinson Disease Rating Scale | Assessment motor and non-motor symptoms of Parkinson Disease | Day 0 and month 3 | 
| King's college Parkinson's disease Pain Scale | Assessment pain, minimum value 0 and maximum value 168 | Day 0 and month 3 | 
| Number of Anti-parkinsonian and psychotropic treatments |  | Day 0 and month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Adapted MBSR program, Feasibility, Efficacy