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

November 5, 2025 updated by: VA Office of Research and Development
To investigate the efficacy of Mindfulness-based Stress Reduction (MBSR) to improve quality of life, cognition, and mood, as well as to determine the longevity of the treatment response in individuals with Parkinson's disease (PD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eligible study participants with PD were randomly assigned to one of two 9-week remote (online) interventions: 1) Mindfulness Based Stress Reduction (MBSR) or 2) Psychoeducational Supportive Care (PSC). Intervention groups consisted of approximately 6-9 individuals and met weekly for 2.5 hours x 8 weeks and for 4 hours ("retreat") during week 7. All participants were remotely administered a battery of neuropsychological tests to measure quality of life, 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 at pre-intervention (baseline), post-intervention (9 weeks), and at 6- and 12-months (follow-up assessments).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161-0002
        • VA San Diego Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Clinical diagnosis of PD based on UK Brain Bank Criteria
  2. 40 years of age or older

Exclusion Criteria:

  1. Secondary causes of Parkinsonism (e.g. corticobasal degeneration, progressive supranuclear palsy, drug-induced parkinsonism)
  2. Other neurological conditions (e.g. stroke)
  3. Clinical diagnosis of dementia based on any previous neuropsychological testing
  4. Psychosis, antipsychotic treatment or treatment for substance abuse
  5. Uncorrected vision or hearing to adequately participate in the intervention
  6. Prior formal training in MBSR or regular current MBSR practice
  7. Inability to use a computer or technology for participation
  8. Active/current suicidal ideation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Mindfulness Based Stress Reduction (MBSR)
Individuals with Parkinson's disease were randomly assigned to one of two study arms: MBSR or PSC. The MBSR intervention was based on the standard program developed by Jon Kabat-Zinn (1990). It consisted of weekly 2.5 hours sessions x 8 weeks and one 4-hour retreat during week 7. Due to the COVID-19 pandemic, all MBSR sessions were conducted completely online with randomized groups of 6-9 individuals with PD and were led by a trained instructor who was not involved in the clinical care or assessment of the participants.
Behavioral: Mindfulness Based Stress Reduction
MBSR used in this trial was based on the standard program developed by Jon Kabat-Zinn (1990). It consisted of weekly 2.5 hours sessions x 8 weeks and one 4-hour retreat during week 7. Due to the COVID-19 pandemic, the MBSR sessions were conducted completely online with randomized groups of 6-9 individuals with PD and were led by a trained instructor who was not involved in the clinical care or assessment of the participants.
Other Names:
  • MBSR
Active Comparator: Psychoeducational Supportive Care (PSC)
Individuals with Parkinson's disease were randomly assigned to one of two study arms: MBSR or PSC. PSC is a novel intervention developed by Schiehser and colleagues to serve as a control for MBSR in this trial. PSC was modeled after common support/education groups that provide support and psychoeducation about Parkinson's disease available in the community. PSC consisted of weekly 2.5 hours sessions x 8 weeks and one 4-hour "retreat" during week 7. Due to the COVID-19 pandemic, all sessions were conducted completely online with randomized groups of 6-9 individuals with PD and were led by a trained instructor who was not involved in the clinical care or assessment of the participants.
Behavioral: Psychoeducational Supportive Care
PSC is a novel intervention developed by Schiehser and colleagues to provide psychoeducation about Parkinson's disease and supportive group care. PSC consisted of weekly 2.5 hours sessions x 8 weeks and one 4-hour "retreat" during week 7. Due to the COVID-19 pandemic, all sessions were conducted completely online with randomized groups of 6-9 individuals with PD and were led by a trained instructor who was not involved in the clinical care or assessment of the participants.
Other Names:
  • PSC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parkinson's Disease Questionnaire-39
Time Frame: pre- to post-intervention (0 to 9 weeks)
Parkinson's disease Quality of Life (PDQ-39); Total Score = 0-156; higher score = worse quality of life.
pre- to post-intervention (0 to 9 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Matrix Reasoning Test
Time Frame: pre- to post-intervention (0 to 9 weeks)
Test My Brain (TMB) Matrix Reasoning Test (MRT); Total Score = 0-36; higher score = better performance.
pre- to post-intervention (0 to 9 weeks)
State-Trait Anxiety Inventory
Time Frame: pre- to post-intervention (0 to 9 weeks)
State-Trait Anxiety Inventory - Trait Subscale (STAI-Trait); 20-80; higher score = higher levels of anxiety.
pre- to post-intervention (0 to 9 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dawn M. Schiehser, PhD, San Diego Veterans Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3154-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on Mindfulness Based Stress Reduction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings