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

NCT05180643 | Completed DMC

• 1 other identifier: CHUBX 2019/32
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson; MBSR; Mindfulness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Achievement of the MBSR (Mindfulness Based Stress Reduction) program from individual pre-program interview

  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

  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

  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

  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

  the pre-program interview will be performed 2 months after inclusion ( one month before the MBSR program's beginning)

Study Arms (2)

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)

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)

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

Interventions

Mindfulness-Based Stress Reduction-based program (MBSR). BEHAVIORAL

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.

non-fluctuating patients or with minor fluctuations (Group A); patients with mild to moderate fluctuations (Group B).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

François TISON, M.D PhD

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• François TISON, M.D PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: January 6, 2022
• Study Start: February 17, 2020
• Primary Completion: August 17, 2021
• Study Completion: November 23, 2021
• Last Updated: January 6, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)