Parkinson's Disease Clinical Trial
Official title:
Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With Parkinson's Disease (PD)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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