NCT05622396

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 16, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 23, 2023

Status Verified

October 1, 2022

Enrollment Period

11 months

First QC Date

October 27, 2022

Last Update Submit

January 20, 2023

Conditions

Parkinson Disease

Keywords

MindfulnessAdapted MBSR programFeasibilityEfficacy

Outcome Measures

Primary Outcomes (1)

  • Assess MBSR program

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

    Month 4

Secondary Outcomes (10)

  • Attendance rate

    Month 3

  • Program tolerance

    month 1 at month 2

  • Relevance of the adaptations put in place

    month 3

  • Beck Depression Inventory

    Day 0 and month 3

  • Parkinson Anxiety Scale (PAS)

    Day 0 and month 3

  • +5 more secondary outcomes

Study Arms (1)

MBSR program adapted

EXPERIMENTAL

8 week program with weekly sessions of 2h30 and a full day of practice designed from the analysis of the post-program interviews

Procedure: Mindfulness Based Stress Reduction

Interventions

Mindfulness Based Stress ReductionPROCEDURE

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.

MBSR program adapted

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xavier Arnozan Hospital

Pessac, 33600, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • François TISON, Pr

    Université Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2022

First Posted

November 18, 2022

Study Start

January 16, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 23, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)