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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Behavioral: Mindfulness Training

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
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2650
    • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Training; Group received Mindfulness Training	Behavioral: Mindfulness Training; Mindfulness Training
No Intervention: Waitlist Control; Group received Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Health Related Quality of Life (PDQ-39)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Scale (Ham-D)		2 years
MRI	Structural and functional MRI pre- and post-MBI	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Barbara A Pickut, MD, MPH, Universiteit Antwerpen

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: May 24, 2012
• First Submitted That Met QC Criteria: May 29, 2012
• First Posted (Estimate): May 30, 2012

Study Record Updates

• Last Update Posted (Estimate): June 16, 2015
• Last Update Submitted That Met QC Criteria: June 13, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Parkinson's Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: B300201213369