Clinical trial NCT05622396: Feasibility of an Adapted Mindfulness Program to Parkinson's Disease
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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Mindfulness
Adapted MBSR program
Feasibility
Efficacy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Assess MBSR program
timeFrame: Month 4
Secondary outcomes:
measure: Attendance rate
timeFrame: Month 3
measure: Program tolerance
timeFrame: month 1 at month 2
measure: Relevance of the adaptations put in place
timeFrame: month 3
measure: Beck Depression Inventory
timeFrame: Day 0 and month 3
measure: Parkinson Anxiety Scale (PAS)
timeFrame: Day 0 and month 3
measure: Parkinson's Disease Sleep Scale
timeFrame: Day 0 and month 3
measure: Parkinson Disease Questionnaire
timeFrame: Day 0 and month 3
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale
timeFrame: Day 0 and month 3
measure: King's college Parkinson's disease Pain Scale
timeFrame: Day 0 and month 3
measure: Number of Anti-parkinsonian and psychotropic treatments
timeFrame: Day 0 and month 3
Other outcomes:
Locations:
city: Pessac
country: France
facility: Xavier Arnozan Hospital
Study officials:
affiliation: Université Hospital, Bordeaux
name: François TISON, Pr
role: PRINCIPAL_INVESTIGATOR
References: