Parkinson's DiseaseMBSRNCT03998462
Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study
A study testing Mindfulness Based Stress Reduction and Psychoeducational Supportive Care in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Mindfulness Based Stress Reduction and Psychoeducational Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of PD based on UK Brain Bank Criteria
- 40 years of age or older
Who cannot join
- 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
- Inability to use a computer or technology for participation
- Active/current suicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161-0002
About this study
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).
Read the 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).
- Conditions
- Parkinson's Disease
- Being tested
- Mindfulness Based Stress Reduction, Psychoeducational Supportive Care
- Keywords
- Mindfulness, Parkinson's disease, Intervention, Mindfulness Based Stress Reduction (MBSR), Mood, Cognition, Quality of Life
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress ReductionBehavioural
Also called MBSR
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.
Psychoeducational Supportive CareBehavioural
Also called PSC
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Active comparator | 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. Receives: Behavioral: Mindfulness Based Stress Reduction |
| Psychoeducational Supportive Care (PSC) | Active comparator | 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. Receives: Behavioral: Psychoeducational Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson's Disease Questionnaire-39
Parkinson's disease Quality of Life (PDQ-39); Total Score = 0-156; higher score = worse quality of life.
Measured: pre- to post-intervention (0 to 9 weeks)
Secondary outcomes (2)
Matrix Reasoning Test
Test My Brain (TMB) Matrix Reasoning Test (MRT); Total Score = 0-36; higher score = better performance.
Measured: pre- to post-intervention (0 to 9 weeks)
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory - Trait Subscale (STAI-Trait); 20-80; higher score = higher levels of anxiety.
Measured: pre- to post-intervention (0 to 9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Jan 2020
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dawn M. Schiehser, PhD, Principal investigator, San Diego Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998462
- Sponsor's protocol ID
- D3154-R
- Acronym
- MBSR
- Status last verified
- Nov 2025
- First submitted
- 24 Jun 2019
- Last updated
- 18 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT03998462
- Acronym / sponsor ID
- MBSR / D3154-R
- Conditions
- Parkinson's Disease
- Keywords
- Mindfulness, Parkinson's disease, Intervention, Mindfulness Based Stress Reduction (MBSR), Mood, Cognition, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Posted 18 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Active comparator | Behavioral: Mindfulness Based Stress ReductionIndividuals 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. |
| Psychoeducational Supportive Care (PSC) | Active comparator | Behavioral: Psychoeducational Supportive CareIndividuals 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of PD based on UK Brain Bank Criteria
- 40 years of age or older
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress ReductionAlso: MBSRMBSR 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. | Behavioural | Mindfulness Based Stress Reduction (MBSR) |
| Psychoeducational Supportive CareAlso: PSCPSC 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. | Behavioural | Psychoeducational Supportive Care (PSC) |
Primary outcome
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.
2 secondary outcomes
Matrix Reasoning Test
Time frame: pre- to post-intervention (0 to 9 weeks)
State-Trait Anxiety Inventory
Time frame: pre- to post-intervention (0 to 9 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn M. Schiehser, PhD principal investigator
San Diego Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction and Psychoeducational Supportive Care in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parkinson's Disease Questionnaire-39 (time frame: pre- to post-intervention (0 to 9 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.