Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study (MBSR)
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ClinicalTrials.gov Identifier: NCT03998462 |
Recruitment Status :
Recruiting
First Posted : June 26, 2019
Last Update Posted : March 24, 2022
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Condition or disease | Intervention/treatment | Phase |
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Parkinson's Disease Mindfulness Based Stress Reduction Quality of Life | Behavioral: Mindfulness Based Stress Reduction Radiation: Creative Education Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 88 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Masking Description: | Investigator and Assessor are blinded to group assignment. |
Primary Purpose: | Treatment |
Official Title: | Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study |
Actual Study Start Date : | January 1, 2020 |
Estimated Primary Completion Date : | November 1, 2024 |
Estimated Study Completion Date : | November 1, 2024 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Mindfulness Based Stress Reduction
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.
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Behavioral: Mindfulness Based Stress Reduction
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.
Other Name: MBSR |
Placebo Comparator: Creative Education Care
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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Radiation: Creative Education Care
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.
Other Name: control group |
- Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index [ Time Frame: 0-9 weeks and 0-62 weeks ]Parkinson's disease Quality of Life (self-report); range = 0-156. Higher scores = poorer quality of life.
- Change in Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test total score [ Time Frame: 0-9 weeks and 0-62 weeks ]Objective measure of executive function; range = 0-26; higher scores = better executive function
- Change in State-Trait Anxiety Inventory (STAI) total score [ Time Frame: 0-9 weeks and 0-62 weeks ]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).

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Ages Eligible for Study: | 41 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998462
Contact: Angelie E Cabrera Tuazon | (858) 552-8585 ext 5593 | Angelie.Tuazon@va.gov | |
Contact: Dawn M Schiehser, PhD | Dawn.Schiehser@va.gov |
United States, California | |
VA San Diego Healthcare System, San Diego, CA | Recruiting |
San Diego, California, United States, 92161 | |
Contact: Patricia A Franklin, AA BS 858-552-8585 ext 7441 patricia.franklin2@va.gov | |
Principal Investigator: Dawn M. Schiehser, PhD |
Principal Investigator: | Dawn M. Schiehser, PhD | VA San Diego Healthcare System, San Diego, CA |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT03998462 |
Other Study ID Numbers: |
D3154-R |
First Posted: | June 26, 2019 Key Record Dates |
Last Update Posted: | March 24, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Mindfulness Parkinson's disease Intervention |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |