NCT01607697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

1.8 years

First QC Date

May 24, 2012

Last Update Submit

June 13, 2015

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Health Related Quality of Life (PDQ-39)

    2 years

Secondary Outcomes (2)

  • Hamilton Depression Scale (Ham-D)

    2 years

  • MRI

    2 years

Study Arms (2)

Mindfulness Training

EXPERIMENTAL

Group received Mindfulness Training

Behavioral: Mindfulness Training

Waitlist Control

NO INTERVENTION

Group received Usual Care

Interventions

Mindfulness TrainingBEHAVIORAL

Mindfulness Training

Mindfulness Training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Antwerp, Antwerp, 2650, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 20876468BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Barbara A Pickut, MD, MPH

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Chief Neurology and Neurorevalidation

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 30, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

BE(1)