Feasibility of an Adapted Mindfulness Program to Parkinson's Disease (MAdaPARK)

A Pilot Feasibility Study of a Co-constructed Program (Patients - Experts) of Mindfulness Meditation Adapted to Patients With Parkinson's Disease.

The objective of this study is to determine the feasibility (primary objective) and the effects (secondary objectives) of an Mindfulness Based Stress Reduction (MBSR) program adapted specifically for patients with Parkinson's disease.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Procedure: Mindfulness Based Stress Reduction

Detailed Description

In Parkinson's disease (PD) the psychological distress (anxiety and depression), is particularly impacting and often resistant to conventional drug treatment explaining the growing interest of patients in non-drug methods, such as mindfulness meditation. The Mindfulness Based Stress Reduction (MBSR) program has been evaluated in Parkinson's disease, showing main effects on anxiety and depression symptoms. These data remain, however, still fragile, particularly in terms of methodological robustness and number of patients involved and variable size of effects. A clinical trial was recently conducted at the Bordeaux University Hospital with 28 patients with Parkinson's disease . Preliminary results suggest that a program tailored specifically to the expectations and needs of patients with Parkinson's disease could, optimize accessibility, acceptability, and patient compliance for this type of approach while preserving clinical efficacy on anxiety and depression.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33600
    • Xavier Arnozan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient suffering from Parkinson's disease,
• Patient aged over 18 and under 80,
• Patient with a Hoehn and Yahr Stage of 1 to 3,
• Patient affiliated or beneficiary of the social security system,
• Patient having signed a free, informed and written consent

Exclusion Criteria:

• Patient with severe motor fluctuations (i.e. scoring 4 to at least one of the following items of part IV of the Movement Disorder Society Unified Parkinson Disease Rating Scale: 4.1 and 4.2 for dyskinesias; 4.3, 4.4 and 4.5 for motor fluctuations),
• Patient with acute depression not stabilized by treatment or dating from less than 6 months,
• Patient with non-stabilized psycho-behavioral disorders (hallucinations, psychoses, impulse control disorders) dating from less than 6 months,
• Patient with major cognitive impairment (Montreal Cognitive Assessment ≤24),
• Patient who has already participated in a structured mindfulness meditation program
• Patient placed under judicial safeguard, guardianship or curator ship,
• Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MBSR program adapted; 8 week program with weekly sessions of 2h30 and a full day of practice designed from the analysis of the post-program interviews

Procedure: Mindfulness Based Stress Reduction; Inspired by the standard Mindfulness Based Stress Reductio program, the study MAdaPARK is a 8 week program with weekly sessions of 2h30 and a full day of practice designed from the analysis of the post-program interviews carried out as part of the M-PARK study,as well as the reflections of the working group specially set up for this purpose. Several areas of adaptation have been identified: shorter mediations, a break time during the sessions, more times for exchanges, a more developed practice in movement, and finally, more important work based on self-esteem and self-compassion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess MBSR program	The rate of patients who have completed the entire MBSR program "adapted"	Month 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance rate	Number of days of practice and daily meditation time.	Month 3
Program tolerance	Number of side effects and the difficulties	month 1 at month 2
Relevance of the adaptations put in place	It will be evaluated from the analysis of feelings and impressions of patients . These different elements will be obtained from the analysis of the semi-directed interviews (qualitative analysis).	month 3
Beck Depression Inventory	Assessment depressive symptoms, minimum value 0 and maximum value 36	Day 0 and month 3
Parkinson Anxiety Scale (PAS)	Assessment anxiety symptoms,minimum value 0 and maximum value 48	Day 0 and month 3
Parkinson's Disease Sleep Scale	Assessment sleep, minimum value 0 and maximum value 60	Day 0 and month 3
Parkinson Disease Questionnaire	Assessment quality of life, minimum value 0 and maximum value 156	Day 0 and month 3
Movement Disorder Society Unified Parkinson Disease Rating Scale	Assessment motor and non-motor symptoms of Parkinson Disease	Day 0 and month 3
King's college Parkinson's disease Pain Scale	Assessment pain, minimum value 0 and maximum value 168	Day 0 and month 3
Number of Anti-parkinsonian and psychotropic treatments		Day 0 and month 3

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: François TISON, Pr, Université Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Feasibility; Efficacy; Mindfulness; Adapted MBSR program
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: CHUBX 2022/54

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