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

NCT ID: NCT05180643

Last Updated: 2022-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2021-11-23

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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)

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François TISON, M.D PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

François TISON, M.D PhD

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2019/32

Identifier Type: -

Identifier Source: org_study_id