Skip to main content
OpenTrials
Completed

NCT Number: NCT01607697

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

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Antwerp

Antwerp, 2650, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Training

Behavioral

Mindfulness Training

Primary outcomes

  1. Health Related Quality of Life (PDQ-39)

    Time frame: 2 years

Secondary outcomes

  1. Hamilton Depression Scale (Ham-D)

    Time frame: 2 years

  2. MRI

    Time frame: 2 years

    Structural and functional MRI pre- and post-MBI

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 30, 2012
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.