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Mindfulness-Based Stress Reduction for Parkinson's Disease (MBSR Trial)

N/A
Waitlist Available
Led By Dawn M. Schiehser, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age over 40 years
Be older than 18 years old
Must not have
Clinical diagnosis of dementia based on any previous neuropsychological testing
Uncorrected vision or hearing to adequately participate in the intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-9 weeks and 0-62 weeks

Summary

This trial will investigate if mindfulness-based stress reduction can help improve quality of life, cognition, and mood in people with Parkinson's disease.

Who is the study for?
This trial is for individuals over 40 with Parkinson's Disease as diagnosed by UK Brain Bank Criteria. It excludes those with vision/hearing issues that affect participation, other neurological conditions or dementia, psychosis or substance abuse treatment history, prior MBSR training or current practice, and recent psychological therapy.
What is being tested?
The study tests if Mindfulness-Based Stress Reduction (MBSR) can improve life quality, cognition, and mood in Parkinson's patients compared to a Creative Education Care group. It also looks at how long these benefits last after the treatment ends.
What are the potential side effects?
While MBSR typically has no severe side effects, participants may experience emotional discomfort when confronting stressful thoughts during mindfulness exercises. The creative education care group should not have significant side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with dementia based on past tests.
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My vision and hearing are good enough to participate.
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My Parkinson's is not caused by drugs or other specific diseases.
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I have a neurological condition like a stroke.
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I am currently having thoughts about harming myself.
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I have completed MBSR training or currently practice MBSR regularly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-9 weeks and 0-62 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-9 weeks and 0-62 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
Change in State-Trait Anxiety Inventory (STAI) total score
Change in Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test total score

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Mindfulness Based Stress ReductionActive Control1 Intervention
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.
Group II: Creative Education CarePlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,505 Total Patients Enrolled
Dawn M. Schiehser, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

Mindfulness Based Stress Reduction Clinical Trial Eligibility Overview. Trial Name: NCT03998462 — N/A
Parkinson's Disease Research Study Groups: Creative Education Care, Mindfulness Based Stress Reduction
Parkinson's Disease Clinical Trial 2023: Mindfulness Based Stress Reduction Highlights & Side Effects. Trial Name: NCT03998462 — N/A
Mindfulness Based Stress Reduction 2023 Treatment Timeline for Medical Study. Trial Name: NCT03998462 — N/A
~19 spots leftby Nov 2025