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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness Training

Group received Mindfulness Training

Group Type EXPERIMENTAL

Mindfulness Training

Intervention Type BEHAVIORAL

Mindfulness Training

Waitlist Control

Group received Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness Training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No