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NCT Number: NCT05622396

Feasibility of an Adapted Mindfulness Program to 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xavier Arnozan Hospital

Pessac, 33600, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Based Stress Reduction

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.

Primary outcomes

  1. Assess MBSR program

    Time frame: Month 4

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

Secondary outcomes

  1. Attendance rate

    Time frame: Month 3

    Number of days of practice and daily meditation time.

  2. Program tolerance

    Time frame: month 1 at month 2

    Number of side effects and the difficulties

  3. Relevance of the adaptations put in place

    Time frame: month 3

    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).

  4. Beck Depression Inventory

    Time frame: Day 0 and month 3

    Assessment depressive symptoms, minimum value 0 and maximum value 36

  5. Parkinson Anxiety Scale (PAS)

    Time frame: Day 0 and month 3

    Assessment anxiety symptoms,minimum value 0 and maximum value 48

  6. Parkinson's Disease Sleep Scale

    Time frame: Day 0 and month 3

    Assessment sleep, minimum value 0 and maximum value 60

  7. Parkinson Disease Questionnaire

    Time frame: Day 0 and month 3

    Assessment quality of life, minimum value 0 and maximum value 156

  8. Movement Disorder Society Unified Parkinson Disease Rating Scale

    Time frame: Day 0 and month 3

    Assessment motor and non-motor symptoms of Parkinson Disease

  9. King's college Parkinson's disease Pain Scale

    Time frame: Day 0 and month 3

    Assessment pain, minimum value 0 and maximum value 168

  10. Number of Anti-parkinsonian and psychotropic treatments

    Time frame: Day 0 and month 3

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: MAdaPARK

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2022
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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