Clinical trial NCT01607697: Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With PD
Official title: Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With Parkinson's Disease (PD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health Related Quality of Life (PDQ-39)
timeFrame: 2 years
Secondary outcomes:
measure: Hamilton Depression Scale (Ham-D)
timeFrame: 2 years
measure: MRI
timeFrame: 2 years
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Barbara A Pickut, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.