A Pilot Feasibility Study of a Co-constructed Program (Patients - Experts) of Mindfulness Meditation Adapted to Patients With Parkinson's Disease.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Assess MBSR program
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Assess MBSR program
Time Frame: Month 4
The rate of patients who have completed the entire MBSR program "adapted"
Secondary Outcomes
- King's college Parkinson's disease Pain Scale(Day 0 and month 3)
- Number of Anti-parkinsonian and psychotropic treatments(Day 0 and month 3)
- Attendance rate(Month 3)
- Beck Depression Inventory(Day 0 and month 3)
- Parkinson Disease Questionnaire(Day 0 and month 3)
- Movement Disorder Society Unified Parkinson Disease Rating Scale(Day 0 and month 3)
- Relevance of the adaptations put in place(month 3)
- Program tolerance(month 1 at month 2)
- Parkinson Anxiety Scale (PAS)(Day 0 and month 3)
- Parkinson's Disease Sleep Scale(Day 0 and month 3)