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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-9 weeks and 0-62 weeks
Awards & highlights
MBSR Trial 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.Check my eligibility
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.See study design
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.
MBSR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 40 years old.
MBSR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-9 weeks and 0-62 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-9 weeks and 0-62 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
MBSR 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,612 Previous Clinical Trials
3,305,635 Total Patients Enrolled
Dawn M. Schiehser, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
110 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with Parkinson's disease using specific criteria from the UK Brain Bank.I have been diagnosed with dementia based on past tests.My vision and hearing are good enough to participate.I have recently started or am currently in a therapy like CBT.My Parkinson's is not caused by drugs or other specific diseases.I have a neurological condition like a stroke.You have been diagnosed with psychosis, are taking antipsychotic medication, or are receiving treatment for substance abuse.I am over 40 years old.I am currently having thoughts about harming myself.I have completed MBSR training or currently practice MBSR regularly.
Research Study Groups:
This trial has the following groups:- Group 1: Creative Education Care
- Group 2: Mindfulness Based Stress Reduction
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit of participants involved in this experiment?
"Affirmative. Clinicaltrials.gov indicates that this experiment, first posted on January 1st 2020, is actively enrolling individuals. 88 patients are required at a single medical centre."
Answered by AI
Are there any vacancies available for individuals to join this medical investigation?
"Affirmative. Details available on clinicaltrials.gov demonstrate that the research is actively recruiting participants, with a launch date of 1/1/2020 and an update as recently as 3/21/2022. A total of 88 patients are being sought out from one unique location."
Answered by AI
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