Feasibility of an Adapted Mindfulness Program to Parkinson's Disease

Not Applicable

Active, not recruiting

• Conditions: Parkinson Disease
• Interventions: Procedure: Mindfulness Based Stress Reduction

• Registration Number: NCT05622396
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-18
• Study Start: 2023-01-16
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MBSR program adapted	Mindfulness Based Stress Reduction	8 week program with weekly sessions of 2h30 and a full day of practice designed from the analysis of the post-program interviews

Primary Outcome Measures

Name	Time	Method
Assess MBSR program	Month 4	The rate of patients who have completed the entire MBSR program "adapted"

Secondary Outcome Measures

Name	Time	Method
King's college Parkinson's disease Pain Scale	Day 0 and month 3	Assessment pain, minimum value 0 and maximum value 168
Number of Anti-parkinsonian and psychotropic treatments	Day 0 and month 3
Attendance rate	Month 3	Number of days of practice and daily meditation time.
Beck Depression Inventory	Day 0 and month 3	Assessment depressive symptoms, minimum value 0 and maximum value 36
Parkinson Disease Questionnaire	Day 0 and month 3	Assessment quality of life, minimum value 0 and maximum value 156
Movement Disorder Society Unified Parkinson Disease Rating Scale	Day 0 and month 3	Assessment motor and non-motor symptoms of Parkinson Disease
Relevance of the adaptations put in place	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).
Program tolerance	month 1 at month 2	Number of side effects and the difficulties
Parkinson Anxiety Scale (PAS)	Day 0 and month 3	Assessment anxiety symptoms,minimum value 0 and maximum value 48
Parkinson's Disease Sleep Scale	Day 0 and month 3	Assessment sleep, minimum value 0 and maximum value 60

Trial Locations

Locations (1)

Xavier Arnozan Hospital; 🇫🇷 Pessac, France