Mindfulness Meditation (MBSR) and Parkinson's Disease (PD) (M-PARK)

May 29, 2026 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • François TISON, M.D PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: non-fluctuating patients or with minor fluctuations (Group A)
Patient without fluctuation or with minor motor fluctuations (rated 0 or 1 on all 5 items of the UPDRS-dyskinesia and Motor Fluctuations scale)
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.
Experimental: patients with mild to moderate fluctuations (Group B).
Patient without fluctuation or with minor to moderate motor fluctuations (rated 2 or 3 on all 5 items of the UPDRS-dyskinesia and Motor Fluctuations scale)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the rate of patients who completed the entire MBSR program
Time Frame: 6 months after inclusion
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Achievement of the MBSR (Mindfulness Based Stress Reduction) program from individual pre-program interview
Time Frame: the pre-program interview will be performed 2 months after inclusion (one month before the MBSR program's beginning)
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)
Achievement of the MBSR (Mindfulness Based Stress Reduction) program from individual post-program interview
Time Frame: the post-program interview will be performed 6 months after inclusion (one month after the end MBSR program)
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)
Acceptability of the MBSR (Mindfulness Based Stress Reduction) program from individual pre-program interview
Time Frame: 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
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
Acceptability of the MBSR (Mindfulness Based Stress Reduction) program from individual post-program interview
Time Frame: the post-program interview will be performed 6 months after inclusion (one month after the end MBSR program)
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)
Expectations with regard to the MBSR (Mindfulness Based Stress Reduction) program determined from individual pre-program interview
Time Frame: the pre-program interview will be performed 2 months after inclusion ( one month before the MBSR program's beginning)
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)
Expectations with regard to the MBSR (Mindfulness Based Stress Reduction)program determined from individual post-program interview
Time Frame: the post-program interview will be performed 6 months after inclusion ( one month after the MBSR program's beginning)
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)
Motor and non-motor symptoms evaluated by the MDS-UPDRS (Unified Parkison's Disease Ratinf Scale) score at the inclusion
Time Frame: at enrollment
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
Motor and non-motor symptoms evaluated by the MDS-UPDRS (Unified Parkison's Disease Ratinf Scale) score at the end of the following period
Time Frame: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
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
Cognitive efficiency evaluated by the "Montreal Cognitive Assessment" (MOCA) at the inclusion
Time Frame: at enrollment
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
Cognitive efficiency evaluated by the "Montreal Cognitive Assessment" (MOCA) at the end of the following period
Time Frame: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
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
subjective quality of sleep evaluated by the " Pittsburgh Sleep Quality Index " at the inclusion
Time Frame: at enrollment
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
subjective quality of sleep evaluated by the " Pittsburgh Sleep Quality Index " at the end of the following period
Time Frame: at enrollment
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
Attentional functions evaluated by the "Test for Attentional Performance" battery (TAP, Zimmerman & Fimm, 2010) at inclusion
Time Frame: at enrollment
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
Attentional functions evaluated by the "Test for Attentional Performance" battery (TAP, Zimmerman & Fimm, 2010) at the end of the following period
Time Frame: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program)
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)
Pain evaluated by the Visual Analog Pain Scale (VAS): at the inclusion
Time Frame: at the inclusion visit
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
Pain evaluated by the Visual Analog Pain Scale (VAS): at the end of the following period
Time Frame: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
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
Quality of life evaluated by the " Parkinson Disease Quotation " (PDQ-39) at the inclusion
Time Frame: at enrollment
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
Quality of life evaluated by the " Parkinson Disease Quotation " (PDQ-39) at the end of the following period
Time Frame: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
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
Anxiety evaluated by the " Parkinson Anxiety Scale " (PAS) at the inclusion
Time Frame: at enrollment
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
Anxiety evaluated by the " Parkinson Anxiety Scale " (PAS) at the end of the following period
Time Frame: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: François TISON, M.D PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2019/32
  • 2019-A02766-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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