Mindfulness Meditation (MBSR) and Parkinson's Disease (PD)

Parkinson Disease Clinical Trial

— M-PARK  

Official title:

Exploratory Feasibility Study for the Development of Mindfulness-based Stress Reduction Program (MBSR )in Parkinsonian Patients - MPARK

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05180643
• Other study ID #: CHUBX 2019/32
• Status: Completed
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: November 23, 2021

Study information

• Verified date: January 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 23, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Mindfulness-Based Stress Reduction-based program (MBSR).
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.

Locations

Country	Name	City	State
France	François TISON, M.D PhD	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of patients who completed the entire MBSR program	the rate of patients who completed the meditation sessions, the full meditation day, and one-to-one daily compliance rate	6 months after inclusion
Secondary	Achievement of the MBSR (Mindfulness Based Stress Reduction) program from individual pre-program interview	Failure factors, problems encountered determined from a individual pre-program interview lasting about 20 minutes for achievement of the MBSR program request	the pre-program interview will be performed 2 months after inclusion (one month before the MBSR program's beginning)
Secondary	Achievement of the MBSR (Mindfulness Based Stress Reduction) program from individual post-program interview	Failure factors, problems encountered determined from a individual post-program interview lasting about 20 minutes for achievement of the MBSR program request	the post-program interview will be performed 6 months after inclusion (one month after the end MBSR program)
Secondary	Acceptability of the MBSR (Mindfulness Based Stress Reduction) program from individual pre-program interview	Program compliance for collective and individual meditations determined from a individual pre-program interview lasting about 20 minutes for acceptability of the MBSR program request	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
Secondary	Acceptability of the MBSR (Mindfulness Based Stress Reduction) program from individual post-program interview	Program compliance for collective and individual meditations determined from a individual post-program interview lasting about 20 minutes for acceptability of the MBSR program request	the post-program interview will be performed 6 months after inclusion (one month after the end MBSR program)
Secondary	Expectations with regard to the MBSR (Mindfulness Based Stress Reduction) program determined from individual pre-program interview	Patient feelings, impressions and attitudes towards the program determined from a individual pre-program interview lasting about 20 minutes for expectations with regard to the MBSR program request	the pre-program interview will be performed 2 months after inclusion ( one month before the MBSR program's beginning)
Secondary	Expectations with regard to the MBSR (Mindfulness Based Stress Reduction)program determined from individual post-program interview	Patient feelings, impressions and attitudes towards the program determined from a individual post-program interview lasting about 20 minutes for the request on expectations with regard to the MBSR program	the post-program interview will be performed 6 months after inclusion ( one month after the MBSR program's beginning)
Secondary	Motor and non-motor symptoms evaluated by the MDS-UPDRS (Unified Parkison's Disease Ratinf Scale) score at the inclusion	The MDS-UPDRS score is based on the "Unified Parkinson's Disease Rating Scale" : the MDS-UPDRS makes it possible to assess the different motor and non-motor symptoms. The MDS-UPDRS has four parts: Non-motor experiences of daily life (13 questions); Motor experiences of daily life (13 questions); Motor exam (18 items); Motor complications (6 items). All items are scored from 0 to 4 and are clearly defined: 0: normal, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe. The duration of the exam is 10 minutes.	at enrollment
Secondary	Motor and non-motor symptoms evaluated by the MDS-UPDRS (Unified Parkison's Disease Ratinf Scale) score at the end of the following period	The MDS-UPDRS score is based on the "Unified Parkinson's Disease Rating Scale": The MDS-UPDRS has four parts: Non-motor experiences of daily life (13 questions); Motor experiences of daily life (13 questions); Motor exam (18 items); Motor complications (6 items). All items are scored from 0 to 4 and are clearly defined: 0: normal, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe. The duration of the exam is 10 minutes.	at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
Secondary	Cognitive efficiency evaluated by the "Montreal Cognitive Assessment" (MOCA) at the inclusion	The "Montreal Cognitive Assessment" (MoCA, [23]). The MoCA assesses mild cognitive dysfunctions. It assesses the following functions: short-term memory, visual spatial skills, executive functions, attention, concentration, working memory, language, abstraction skills, calculation and orientation in the time and space. Cognitive impairment is assessed in terms of the score on 30 points (27-30: no cognitive impairment; 18-26: mild; 10-17: moderate; <10: severe). The duration of the test is 20 minutes.	at enrollment
Secondary	Cognitive efficiency evaluated by the "Montreal Cognitive Assessment" (MOCA) at the end of the following period	The "Montreal Cognitive Assessment" (MoCA, [23]). The MoCA assesses mild cognitive dysfunctions. It assesses the following functions: short-term memory, visual spatial skills, executive functions, attention, concentration, working memory, language, abstraction skills, calculation and orientation in the time and space. Cognitive impairment is assessed in terms of the score on 30 points (27-30: no cognitive impairment; 18-26: mild; 10-17: moderate; <10: severe). The duration of the test is 20 minutes.	at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
Secondary	subjective quality of sleep evaluated by the " Pittsburgh Sleep Quality Index " at the inclusion	This is a self-questionnaire that assesses the subjective quality of sleep in the past month. It includes 19 questions used to calculate 7 components: subjective quality of sleep, sleep latency, sleep duration, sleep efficiency, sleep disturbance, sleep medication, disturbances in daytime functioning. The overall score is obtained by summing the seven components. It ranges from 0: "no difficulty" to 21: "major difficulties".	at enrollment
Secondary	subjective quality of sleep evaluated by the " Pittsburgh Sleep Quality Index " at the end of the following period	This is a self-questionnaire that assesses the subjective quality of sleep in the past month. It includes 19 questions used to calculate 7 components: subjective quality of sleep, sleep latency, sleep duration, sleep efficiency, sleep disturbance, sleep medication, disturbances in daytime functioning. The overall score is obtained by summing the seven components. It ranges from 0: "no difficulty" to 21: "major difficulties".	at enrollment
Secondary	Attentional functions evaluated by the "Test for Attentional Performance" battery (TAP, Zimmerman & Fimm, 2010) at inclusion	It is a test evaluating the attentional functions (phasic alert, divided attention, sustained attention, visual scanning, intermodal comparison, displacement of the attentional focus, exploration of the visual field / neglect, flexibility, go / nogo, incompatibility, memory of work, eye motility, alertness).	at enrollment
Secondary	Attentional functions evaluated by the "Test for Attentional Performance" battery (TAP, Zimmerman & Fimm, 2010) at the end of the following period	It is a test evaluating the attentional functions (phasic alert, divided attention, sustained attention, visual scanning, intermodal comparison, displacement of the attentional focus, exploration of the visual field / neglect, flexibility, go / nogo, incompatibility, memory of work, eye motility, alertness). The duration of the test is 60 minutes.	at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program)
Secondary	Pain evaluated by the Visual Analog Pain Scale (VAS): at the inclusion	It is a pain self-assessment scale that allows the patient to self-assess the pain experienced by means of a cursor. A slider allows the patient to self-assess the pain felt by means of a cursor. On the front of the slide, a line or pyramid is drawn on which the patient moves the cursor from the "no pain" end to the "maximum pain imaginable" end. On the back of the slide, the caregiver reads the pain felt by the patient using a scale in millimeters (from 0 to 100 mm). Rating is pain absent: 0, mild pain: 1 to 3, moderate pain: 4 to 6, severe pain: 7 to 9, extremely intense pain: 10.	at the inclusion visit
Secondary	Pain evaluated by the Visual Analog Pain Scale (VAS): at the end of the following period	It is a pain self-assessment scale that allows the patient to self-assess the pain experienced by means of a cursor. A slider allows the patient to self-assess the pain felt by means of a cursor. On the front of the slide, a line or pyramid is drawn on which the patient moves the cursor from the "no pain" end to the "maximum pain imaginable" end. On the back of the slide, the caregiver reads the pain felt by the patient using a scale in millimeters (from 0 to 100 mm). Rating is pain absent: 0, mild pain: 1 to 3, moderate pain: 4 to 6, severe pain: 7 to 9, extremely intense pain: 10.	at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
Secondary	Quality of life evaluated by the " Parkinson Disease Quotation " (PDQ-39) at the inclusion	It is a self-questionnaire in 39 items assessing the quality of life of Parkinson's patients from a motor and psychological point of view, according to the past month. Each question is scored from 0 (no disturbance) to 4 (maximum disturbance). The items are divided into 8 dimensions (activity of daily life, emotional well-being, psychological discomfort, social support, cognitive disorders, communication, physical discomfort, mobility).	at enrollment
Secondary	Quality of life evaluated by the " Parkinson Disease Quotation " (PDQ-39) at the end of the following period	It is a self-questionnaire in 39 items assessing the quality of life of Parkinson's patients from a motor and psychological point of view, according to the past month. Each question is scored from 0 (no disturbance) to 4 (maximum disturbance). The items are divided into 8 dimensions (activity of daily life, emotional well-being, psychological discomfort, social support, cognitive disorders, communication, physical discomfort, mobility).	at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
Secondary	Anxiety evaluated by the " Parkinson Anxiety Scale " (PAS) at the inclusion	It is a self-questionnaire evaluating anxiety in Parkinson's disease dealing with several dimensions of anxiety: Persistent anxiety (5 items), Episodic anxiety (4 items), Avoidance behavior (3 items) . Each item is rated from 0 (not at all) to 4 (strongly or almost always). The filling time is 5 minutes.	at enrollment
Secondary	Anxiety evaluated by the " Parkinson Anxiety Scale " (PAS) at the end of the following period	It is a self-questionnaire evaluating anxiety in Parkinson's disease dealing with several dimensions of anxiety: Persistent anxiety (5 items), Episodic anxiety (4 items), Avoidance behavior (3 items) . Each item is rated from 0 (not at all) to 4 (strongly or almost always). The filling time is 5 minutes.	at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program