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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

Tracking Information
First Submitted Date  ICMJE May 24, 2012
First Posted Date  ICMJE May 30, 2012
Last Update Posted Date June 16, 2015
Study Start Date  ICMJE March 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
Health Related Quality of Life (PDQ-39) [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01607697 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2012)
  • Hamilton Depression Scale (Ham-D) [ Time Frame: 2 years ]
  • MRI [ Time Frame: 2 years ]
    Structural and functional MRI pre- and post-MBI
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
Hamilton Depression Scale (Ham-D) [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With PD
Official Title  ICMJE Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With Parkinson's Disease (PD)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Behavioral: Mindfulness Training
Mindfulness Training
Study Arms  ICMJE
  • Experimental: Mindfulness Training
    Group received Mindfulness Training
    Intervention: Behavioral: Mindfulness Training
  • No Intervention: Waitlist Control
    Group received Usual Care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2015)
42
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2012)
100
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01607697
Other Study ID Numbers  ICMJE B300201213369
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Barbara A. Pickut, University Hospital, Antwerp
Study Sponsor  ICMJE University Hospital, Antwerp
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara A Pickut, MD, MPH Universiteit Antwerpen
PRS Account University Hospital, Antwerp
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP