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

Primary Purpose

Parkinson Disease

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson Disease focused on measuring Mindfulness, Adapted MBSR program, Feasibility, Efficacy

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xavier Arnozan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MBSR program adapted

Arm Description

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

Outcomes

Primary Outcome Measures

Assess MBSR program
The rate of patients who have completed the entire MBSR program "adapted"

Secondary Outcome Measures

Attendance rate
Number of days of practice and daily meditation time.
Program tolerance
Number of side effects and the difficulties
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).
Beck Depression Inventory
Assessment depressive symptoms, minimum value 0 and maximum value 36
Parkinson Anxiety Scale (PAS)
Assessment anxiety symptoms,minimum value 0 and maximum value 48
Parkinson's Disease Sleep Scale
Assessment sleep, minimum value 0 and maximum value 60
Parkinson Disease Questionnaire
Assessment quality of life, minimum value 0 and maximum value 156
Movement Disorder Society Unified Parkinson Disease Rating Scale
Assessment motor and non-motor symptoms of Parkinson Disease
King's college Parkinson's disease Pain Scale
Assessment pain, minimum value 0 and maximum value 168
Number of Anti-parkinsonian and psychotropic treatments

Full Information

First Posted
October 27, 2022
Last Updated
January 20, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT05622396
Brief Title
Feasibility of an Adapted Mindfulness Program to Parkinson's Disease
Acronym
MAdaPARK
Official Title
A Pilot Feasibility Study of a Co-constructed Program (Patients - Experts) of Mindfulness Meditation Adapted to Patients With Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Mindfulness, Adapted MBSR program, Feasibility, Efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MBSR program adapted
Arm Type
Experimental
Arm Description
8 week program with weekly sessions of 2h30 and a full day of practice designed from the analysis of the post-program interviews
Intervention Type
Procedure
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess MBSR program
Description
The rate of patients who have completed the entire MBSR program "adapted"
Time Frame
Month 4
Secondary Outcome Measure Information:
Title
Attendance rate
Description
Number of days of practice and daily meditation time.
Time Frame
Month 3
Title
Program tolerance
Description
Number of side effects and the difficulties
Time Frame
month 1 at month 2
Title
Relevance of the adaptations put in place
Description
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).
Time Frame
month 3
Title
Beck Depression Inventory
Description
Assessment depressive symptoms, minimum value 0 and maximum value 36
Time Frame
Day 0 and month 3
Title
Parkinson Anxiety Scale (PAS)
Description
Assessment anxiety symptoms,minimum value 0 and maximum value 48
Time Frame
Day 0 and month 3
Title
Parkinson's Disease Sleep Scale
Description
Assessment sleep, minimum value 0 and maximum value 60
Time Frame
Day 0 and month 3
Title
Parkinson Disease Questionnaire
Description
Assessment quality of life, minimum value 0 and maximum value 156
Time Frame
Day 0 and month 3
Title
Movement Disorder Society Unified Parkinson Disease Rating Scale
Description
Assessment motor and non-motor symptoms of Parkinson Disease
Time Frame
Day 0 and month 3
Title
King's college Parkinson's disease Pain Scale
Description
Assessment pain, minimum value 0 and maximum value 168
Time Frame
Day 0 and month 3
Title
Number of Anti-parkinsonian and psychotropic treatments
Time Frame
Day 0 and month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François TISON, Pr
Organizational Affiliation
Université Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xavier Arnozan Hospital
City
Pessac
ZIP/Postal Code
33600
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of an Adapted Mindfulness Program to Parkinson's Disease

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