Feasibility of an Adapted Mindfulness Program to Parkinson's Disease

NCT ID: NCT05622396

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-16
• Study Completion Date: 2023-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Mindfulness Based Stress Reduction

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 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, Pr

Role: PRINCIPAL_INVESTIGATOR

Université Hospital, Bordeaux

Locations

Xavier Arnozan Hospital

Pessac, , France

Countries

France

Other Identifiers

CHUBX 2022/54

Identifier Type: -

Identifier Source: org_study_id