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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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ClinicalTrials.gov Identifier: NCT01607697
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Barbara A. Pickut, University Hospital, Antwerp

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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Mindfulness Training Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With Parkinson's Disease (PD)
Study Start Date : March 2012
Primary Completion Date : January 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mindfulness Training
Group received Mindfulness Training
Behavioral: Mindfulness Training
Mindfulness Training
No Intervention: Waitlist Control
Group received Usual Care



Primary Outcome Measures :
  1. Health Related Quality of Life (PDQ-39) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Hamilton Depression Scale (Ham-D) [ Time Frame: 2 years ]
  2. MRI [ Time Frame: 2 years ]
    Structural and functional MRI pre- and post-MBI



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607697


Locations
Belgium
University Hospital Antwerp
Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: Barbara A Pickut, MD, MPH Universiteit Antwerpen

Publications:
Responsible Party: Dr. Barbara A. Pickut, Clinical Chief Neurology and Neurorevalidation, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01607697     History of Changes
Other Study ID Numbers: B300201213369
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

Keywords provided by Dr. Barbara A. Pickut, University Hospital, Antwerp:
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases