NCT03998462

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 18, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

4.8 years

First QC Date

June 24, 2019

Results QC Date

November 5, 2025

Last Update Submit

November 5, 2025

Conditions

Keywords

MindfulnessParkinson's diseaseInterventionMindfulness Based Stress Reduction (MBSR)MoodCognitionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Parkinson's Disease Questionnaire-39

    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 Outcomes (2)

  • Matrix Reasoning Test

    pre- to post-intervention (0 to 9 weeks)

  • State-Trait Anxiety Inventory

    pre- to post-intervention (0 to 9 weeks)

Study Arms (2)

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.

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.

Behavioral: Psychoeducational Supportive Care

Interventions

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.

Also known as: MBSR
Mindfulness Based Stress Reduction (MBSR)

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.

Also known as: PSC
Psychoeducational Supportive Care (PSC)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of PD based on UK Brain Bank Criteria
  • years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Outcome measures were adjusted and/or modified in order to be administered online due to the COVID-19 pandemic.

Results Point of Contact

Title
Dr. Dawn Schiehser, Ph.D.
Organization
North Florida/South Georgia VA Healthcare System

Study Officials

  • Dawn M. Schiehser, PhD

    San Diego Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigator and Assessor are blinded to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 26, 2019

Study Start

January 1, 2020

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

November 18, 2025

Results First Posted

November 18, 2025

Record last verified: 2025-11

Locations