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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBSR program adapted | Experimental | 8 week program with weekly sessions of 2h30 and a full day of practice designed from the analysis of the post-program interviews |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess MBSR program | The rate of patients who have completed the entire MBSR program "adapted" | Month 4 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François TISON, Pr | Université Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xavier Arnozan Hospital | Pessac | 33600 | France |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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|
| 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D004191 |
| Behavioral Disciplines and Activities |