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Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With PD

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Mindfulness Training
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson's Disease focused on measuring Parkinson's Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of PD according to the UK Brain Bank Criteria;
  • Patients in Hoehn & Yahr stage 1-3;
  • Lack of features suggestive of atypical Parkinsonism;
  • No history of neuroleptics or other drugs that induce parkinsonism in the last 60 days;
  • Currently optimally treated with medication and unlikely to be requiring anti-PD medication adjustments in the next 4 months;
  • On a stable dose of all medications for 30 days;
  • Lack of cognitive dysfunction as based on the MoCA (score ≥ 26).

Exclusion Criteria:

  • Cognitive dysfunction based on the MoCA (score < 26);
  • Patients with Hoehn & Yahr stage 4 and above when in 'on' stage;
  • Unstable, major psychiatric or life threatening concomitant disease.

Sites / Locations

  • University Hospital Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness Training

Waitlist Control

Arm Description

Group received Mindfulness Training

Group received Usual Care

Outcomes

Primary Outcome Measures

Health Related Quality of Life (PDQ-39)

Secondary Outcome Measures

Hamilton Depression Scale (Ham-D)
MRI
Structural and functional MRI pre- and post-MBI

Full Information

First Posted
May 24, 2012
Last Updated
June 13, 2015
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT01607697
Brief Title
Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With PD
Official Title
Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With Parkinson's Disease (PD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Scientific Abstract: The investigators propose a study to examine the impact of a Mindfulness Based Intervention (MBI) on the quality of life and Non-Motor Symptoms (NMS) of persons with Parkinson's disease (PD). NMS add significantly to the disease burden and negatively impact the quality of life in PD (1,2). In a previous study the investigators confirmed the high prevalence of NMS in PD patients with either early- or late-onset of disease (3). Despite currently available treatments, PD leads to worsening disability and there remains a need for new approaches. A Mindfulness Based Intervention may provide an important adjuvant therapy in the treatment of PD in relation to NMS and quality of life. A minimum of 100 patients will be randomly assigned to the MBI or 'Treatment As Usual' (TAU) groups. Clinical assessments (motor and non-motor scores) will be performed in both groups. The TAU group will be offered MBI after completion of the study. To the best of our knowledge, this is the first large scale study using MBI in this indication.
Detailed Description
The investigators propose a study to examine the impact of a Mindfulness Based Intervention (MBI) on the quality of life and Non-Motor Symptoms (NMS) of persons with Parkinson's disease (PD). NMS add significantly to the disease burden and negatively impact the quality of life in PD (1,2). In a previous study the investigators confirmed the high prevalence of NMS in PD patients with either early- or late-onset of disease (3). Despite currently available treatments, PD leads to worsening disability and there remains a need for new approaches. A Mindfulness Based Intervention may provide an important adjuvant therapy in the treatment of PD in relation to NMS and quality of life. A minimum of 100 patients will be randomly assigned to the MBI or 'Treatment As Usual' (TAU) groups. Clinical assessments (motor and non-motor scores) will be performed in both groups. The TAU group will be offered MBI after completion of the study. To the best of our knowledge, this is the first large scale study using MBI in this indication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Training
Arm Type
Experimental
Arm Description
Group received Mindfulness Training
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Group received Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Training
Intervention Description
Mindfulness Training
Primary Outcome Measure Information:
Title
Health Related Quality of Life (PDQ-39)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Hamilton Depression Scale (Ham-D)
Time Frame
2 years
Title
MRI
Description
Structural and functional MRI pre- and post-MBI
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of PD according to the UK Brain Bank Criteria; Patients in Hoehn & Yahr stage 1-3; Lack of features suggestive of atypical Parkinsonism; No history of neuroleptics or other drugs that induce parkinsonism in the last 60 days; Currently optimally treated with medication and unlikely to be requiring anti-PD medication adjustments in the next 4 months; On a stable dose of all medications for 30 days; Lack of cognitive dysfunction as based on the MoCA (score ≥ 26). Exclusion Criteria: Cognitive dysfunction based on the MoCA (score < 26); Patients with Hoehn & Yahr stage 4 and above when in 'on' stage; Unstable, major psychiatric or life threatening concomitant disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara A Pickut, MD, MPH
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Antwerp
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
20876468
Citation
Grossman P, Kappos L, Gensicke H, D'Souza M, Mohr DC, Penner IK, Steiner C. MS quality of life, depression, and fatigue improve after mindfulness training: a randomized trial. Neurology. 2010 Sep 28;75(13):1141-9. doi: 10.1212/WNL.0b013e3181f4d80d.
Results Reference
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Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With PD

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