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Completed

NCT Number: NCT03998462

Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal 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).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System

San Diego, California, 92161-0002, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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
  • Inability to use a computer or technology for participation
  • Active/current suicidal ideation

Treatment and study plan

Mindfulness Based Stress Reduction

Behavioral

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

Psychoeducational Supportive Care

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: MBSR

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2019
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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