Feasibility of an Adapted Mindfulness Program to Parkinson's Disease

Parkinson Disease Clinical Trial

— MAdaPARK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05622396
• Other study ID #: CHUBX 2022/54
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
France	Xavier Arnozan Hospital	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess MBSR program	The rate of patients who have completed the entire MBSR program "adapted"	Month 4
Secondary	Attendance rate	Number of days of practice and daily meditation time.	Month 3
Secondary	Program tolerance	Number of side effects and the difficulties	month 1 at month 2
Secondary	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
Secondary	Beck Depression Inventory	Assessment depressive symptoms, minimum value 0 and maximum value 36	Day 0 and month 3
Secondary	Parkinson Anxiety Scale (PAS)	Assessment anxiety symptoms,minimum value 0 and maximum value 48	Day 0 and month 3
Secondary	Parkinson's Disease Sleep Scale	Assessment sleep, minimum value 0 and maximum value 60	Day 0 and month 3
Secondary	Parkinson Disease Questionnaire	Assessment quality of life, minimum value 0 and maximum value 156	Day 0 and month 3
Secondary	Movement Disorder Society Unified Parkinson Disease Rating Scale	Assessment motor and non-motor symptoms of Parkinson Disease	Day 0 and month 3
Secondary	King's college Parkinson's disease Pain Scale	Assessment pain, minimum value 0 and maximum value 168	Day 0 and month 3
Secondary	Number of Anti-parkinsonian and psychotropic treatments		Day 0 and month 3