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

University Hospital of Bordeaux

Status

Active, not recruiting

Conditions

Parkinson Disease

Treatments

Procedure: Mindfulness Based Stress Reduction

Study type

Interventional

Funder types

Other

Identifiers

NCT05622396

CHUBX 2022/54

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No 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.