Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study

Study Overview
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Brief Summary
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To investigate the efficacy of Mindfulness-based Stress Reduction (MBSR),to improve HRQoL, cognition, and mood, as well as to determine the longevity of the treatment response in individuals with Parkinson's disease (PD).

Detailed Description
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Eligible study participants will be randomly assigned to one of two interventions: 1) Mindfulness Based Stress Reduction for Parkinson's disease; MBSR-PD or 2) Creative Education Care (CEC). Study visits may be held remotely, via online video format (Webex). Interventions are held within a group format consisting of approximately 6-10 individuals with PD. Groups will meet once per week for over a 9-week period. All participants will be administered a battery of neuropsychological tests to measure HRQoL, cognition (e.g., executive function, attention, memory), and mood (i.e., anxiety, depression, and apathy), as well as motor symptoms, disease severity, and mindfulness engagement/practice. Tests will be administered at baseline, 9 weeks (post-treatment), and 6- and 12-months (follow-up assessments) by an examiner blinded to group assignment.

Official Title
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Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study

Conditions
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Parkinson's Disease, Mindfulness Based Stress Reduction, Quality of Life

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction
* Behavioral: Creative Education Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of PD based on UK Brain Bank Criteria >40 years of age Exclusion Criteria: Secondary causes of Parkinsonism (e.g. corticobasal degeneration, progressive supranuclear palsy, drug-induced parkinsonism) Other neurological conditions (e.g. stroke) Clinical diagnosis of dementia based on any previous neuropsychological testing Psychosis, antipsychotic treatment or treatment for substance abuse Uncorrected vision or hearing to adequately participate in the intervention Prior formal training in MBSR or regular current MBSR practice Recent or new participation in a psychological/behavioral treatment, such as Cognitive Behavioral Therapy (CBT) Active/current suicidal ideation

Ages Eligible for Study
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Minimum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness Based Stress Reduction<br>MBSR consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants. | Behavioral: Mindfulness Based Stress Reduction<br>* MBSR consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.<br>* Other names: MBSR;|
| Placebo Comparator: Creative Education Care<br>Creative Education Care consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants. | Behavioral: Creative Education Care<br>* Creative Education Care consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index | Parkinson's disease Quality of Life (self-report); range = 0-156. Higher scores = poorer quality of life. | 0-9 weeks and 0-62 weeks | 
| Change in Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test total score | Objective measure of executive function; range = 0-26; higher scores = better executive function | 0-9 weeks and 0-62 weeks | 
| Change in State-Trait Anxiety Inventory (STAI) total score | Measure of anxiety; range of possible scores from 20-80; no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80). | 0-9 weeks and 0-62 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Parkinson's disease, Intervention