Clinical trial NCT05180643: Mindfulness Meditation (MBSR) and Parkinson's Disease (PD)
Official title: Exploratory Feasibility Study for the Development of Mindfulness-based Stress Reduction Program (MBSR )in Parkinsonian Patients - MPARK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson
MBSR
Mindfulness
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with Parkinson's disease
* Aged over 18
* Under 80 years old
* Patient without fluctuation or with minor to moderate motor fluctuations (rated 0 or 3 on all 5 items of the UPDRS-dyskinesia and Motor Fluctuations scale)
* Patient with Hoehn Stadium and Yahr from 1 to 3
* Patient not presenting with acute depression not stabilized by the treatment or during the last 6 months
* Patient without unstable psycho-behavioral disorders (hallucinations, psychoses, impulse control disorders) less than 6 months
* Patient affiliated or beneficiary of the social security scheme
* Free, informed and written consent (at the latest on the day of inclusion and before any research required by the research).

Exclusion Criteria:

* Patient with Hoehn Stadium and Yahr over 3
* Patient with major cognitive impairment (MOCA \<24)
* Patient with severe motor fluctuation (rated\> 3 for all 5 items on the dyskinesia MDS-UPDRS scale and Motor Fluctuations)

Primary outcomes:
measure: the rate of patients who completed the entire MBSR program
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Achievement of the MBSR (Mindfulness Based Stress Reduction) program from individual pre-program interview
timeFrame: the pre-program interview will be performed 2 months after inclusion (one month before the MBSR program's beginning)
measure: Achievement of the MBSR (Mindfulness Based Stress Reduction) program from individual post-program interview
timeFrame: the post-program interview will be performed 6 months after inclusion (one month after the end MBSR program)
measure: Acceptability of the MBSR (Mindfulness Based Stress Reduction) program from individual pre-program interview
timeFrame: the pre-program interview will be performed 2 months after inclusion ( one month before the MBSR program's beginning) and will last about one hour in total
measure: Acceptability of the MBSR (Mindfulness Based Stress Reduction) program from individual post-program interview
timeFrame: the post-program interview will be performed 6 months after inclusion (one month after the end MBSR program)
measure: Expectations with regard to the MBSR (Mindfulness Based Stress Reduction) program determined from individual pre-program interview
timeFrame: the pre-program interview will be performed 2 months after inclusion ( one month before the MBSR program's beginning)
measure: Expectations with regard to the MBSR (Mindfulness Based Stress Reduction)program determined from individual post-program interview
timeFrame: the post-program interview will be performed 6 months after inclusion ( one month after the MBSR program's beginning)
measure: Motor and non-motor symptoms evaluated by the MDS-UPDRS (Unified Parkison's Disease Ratinf Scale) score at the inclusion
timeFrame: at enrollment
measure: Motor and non-motor symptoms evaluated by the MDS-UPDRS (Unified Parkison's Disease Ratinf Scale) score at the end of the following period
timeFrame: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
measure: Cognitive efficiency evaluated by the "Montreal Cognitive Assessment" (MOCA) at the inclusion
timeFrame: at enrollment
measure: Cognitive efficiency evaluated by the "Montreal Cognitive Assessment" (MOCA) at the end of the following period
timeFrame: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
measure: subjective quality of sleep evaluated by the " Pittsburgh Sleep Quality Index " at the inclusion
timeFrame: at enrollment
measure: subjective quality of sleep evaluated by the " Pittsburgh Sleep Quality Index " at the end of the following period
timeFrame: at enrollment
measure: Attentional functions evaluated by the "Test for Attentional Performance" battery (TAP, Zimmerman & Fimm, 2010) at inclusion
timeFrame: at enrollment
measure: Attentional functions evaluated by the "Test for Attentional Performance" battery (TAP, Zimmerman & Fimm, 2010) at the end of the following period
timeFrame: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program)
measure: Pain evaluated by the Visual Analog Pain Scale (VAS): at the inclusion
timeFrame: at the inclusion visit
measure: Pain evaluated by the Visual Analog Pain Scale (VAS): at the end of the following period
timeFrame: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
measure: Quality of life evaluated by the " Parkinson Disease Quotation " (PDQ-39) at the inclusion
timeFrame: at enrollment
measure: Quality of life evaluated by the " Parkinson Disease Quotation " (PDQ-39) at the end of the following period
timeFrame: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
measure: Anxiety evaluated by the " Parkinson Anxiety Scale " (PAS) at the inclusion
timeFrame: at enrollment
measure: Anxiety evaluated by the " Parkinson Anxiety Scale " (PAS) at the end of the following period
timeFrame: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: François TISON, M.D PhD
Study officials:
affiliation: University Hospital, Bordeaux
name: François TISON, M.D PhD
role: PRINCIPAL_INVESTIGATOR
References: