Clinical Trial: Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With PD
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Summary:
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.
Sponsor: University Hospital, Antwerp
Current Primary Outcome: Health Related Quality of Life (PDQ-39) [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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: Hamilton Depression Scale (Ham-D) [ Time Frame: 2 years ]
Information By: University Hospital, Antwerp
Dates:
Date Received: May 24, 2012
Date Started: March 2012
Date Completion:
Last Updated: June 13, 2015
Last Verified: June 2015
