Parkinson DiseaseM-PARKNCT05180643
Mindfulness Meditation (MBSR) and Parkinson's Disease (PD)
A study testing Mindfulness-Based Stress Reduction-based program (MBSR). in people with Parkinson Disease, run by University Hospital, Bordeaux at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Mindfulness-Based Stress Reduction-based program (MBSR).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2020to 23 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Mindfulness-Based Stress Reduction-based program (MBSR).
- Keywords
- Parkinson, MBSR, Mindfulness
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction-based program (MBSR).Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| non-fluctuating patients or with minor fluctuations (Group A) | Experimental | Patient without fluctuation or with minor motor fluctuations (rated 0 or 1 on all 5 items of the UPDRS-dyskinesia and Motor Fluctuations scale) Receives: Behavioral: Mindfulness-Based Stress Reduction-based program (MBSR). |
| patients with mild to moderate fluctuations (Group B). | Experimental | 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) Receives: Behavioral: Mindfulness-Based Stress Reduction-based program (MBSR). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after inclusion
Secondary outcomes (20)
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
Measured: 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
Failure factors, problems encountered determined from a individual post-program interview lasting about 20 minutes for achievement of the MBSR program request
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: at enrollment
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.
Measured: 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
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".
Measured: at enrollment
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".
Measured: at enrollment
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).
Measured: at enrollment
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.
Measured: 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
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.
Measured: at the inclusion visit
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.
Measured: 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
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).
Measured: at enrollment
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).
Measured: 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
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.
Measured: at enrollment
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.
Measured: at the end of the following period ( i.e. 6 months after the inclusion, 1 month after the end of the MBSR program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start17 Feb 2020
- Primary completion17 Aug 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François TISON, M.D PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180643
- Sponsor's protocol ID
- CHUBX 2019/32
- Other IDs
- 2019-A02766-51
- Acronym
- M-PARK
- Status last verified
- Jan 2022
- First submitted
- 6 Feb 2020
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Feasibility Study for the Development of Mindfulness-based Stress Reduction Program (MBSR )in Parkinsonian Patients - MPARK
- ClinicalTrials.gov ID
- NCT05180643
- Acronym / sponsor ID
- M-PARK / CHUBX 2019/32
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, MBSR, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| non-fluctuating patients or with minor fluctuations (Group A) | Experimental | Behavioral: Mindfulness-Based Stress Reduction-based program (MBSR).Patient without fluctuation or with minor motor fluctuations (rated 0 or 1 on all 5 items of the UPDRS-dyskinesia and Motor Fluctuations scale) |
| patients with mild to moderate fluctuations (Group B). | Experimental | Behavioral: Mindfulness-Based Stress Reduction-based program (MBSR).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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | non-fluctuating patients or with minor fluctuations (Group A), patients with mild to moderate fluctuations (Group B). |
Primary outcome
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
20 secondary outcomes
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)
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)
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
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)
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)
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)
Motor and non-motor symptoms evaluated by the MDS-UPDRS (Unified Parkison's Disease Ratinf Scale) score at the inclusion
Time frame: 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
Cognitive efficiency evaluated by the "Montreal Cognitive Assessment" (MOCA) at the inclusion
Time frame: 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
subjective quality of sleep evaluated by the " Pittsburgh Sleep Quality Index " at the inclusion
Time frame: at enrollment
subjective quality of sleep evaluated by the " Pittsburgh Sleep Quality Index " at the end of the following period
Time frame: at enrollment
Attentional functions evaluated by the "Test for Attentional Performance" battery (TAP, Zimmerman & Fimm, 2010) at inclusion
Time frame: 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)
Pain evaluated by the Visual Analog Pain Scale (VAS): at the inclusion
Time frame: 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
Quality of life evaluated by the " Parkinson Disease Quotation " (PDQ-39) at the inclusion
Time frame: 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
Anxiety evaluated by the " Parkinson Anxiety Scale " (PAS) at the inclusion
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François TISON, M.D PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction-based program (MBSR). in people with Parkinson Disease, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of patients who completed the entire MBSR program (time frame: 6 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.