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

NCT03998462 — Not applicable, Completed, 107 participants, VA Office of Research and Development

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RegistryNCT03998462, acronym MBSR
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment107 (Actual)
SponsorVA Office of Research and Development (Fed)
ConditionsParkinson's Disease
InterventionsMindfulness Based Stress Reduction, Psychoeducational Supportive Care (Behavioral)
Datesstart 2020-01-01, primary completion 2024-11-01, completion 2024-11-01, first posted 2019-06-26, last updated 2025-11-18
Locations1 site in United States

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-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).

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
Mindfulness Based Stress Reduction (MBSR)Active comparatorBehavioral: 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 comparatorBehavioral: 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.
  • Mindfulness Based Stress Reduction (Behavioral), also known as 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 Care (Behavioral), also known as 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.

+Outcome measures

Primary outcomes

  • Parkinson's Disease Questionnaire-39 [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

  • Matrix Reasoning Test [pre- to post-intervention (0 to 9 weeks)]: Test My Brain (TMB) Matrix Reasoning Test (MRT); Total Score = 0-36; higher score = better performance.
  • State-Trait Anxiety Inventory [pre- to post-intervention (0 to 9 weeks)]: State-Trait Anxiety Inventory - Trait Subscale (STAI-Trait); 20-80; higher score = higher levels of anxiety.

+Eligibility

Sex: All, ages: 40 Years to any

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

+Posted results

Participant flow

MilestoneMindfulness Based Stress Reduction (MBSR)Psychoeducational Supportive Care (PSC)
Started5251
Completed4045
Not completed126

Outcome results

  • Parkinson's Disease Questionnaire-39 (Primary), Mean, change score: Mindfulness Based Stress Reduction (MBSR) -1.03 +/- 9.71; Psychoeducational Supportive Care (PSC) -3.04 +/- 7.94 (p 0.34)
  • Matrix Reasoning Test (Secondary), Mean, change score: Mindfulness Based Stress Reduction (MBSR) 0.154 +/- 6.54; Psychoeducational Supportive Care (PSC) 1.04 +/- 5.92 (p 0.41)
  • State-Trait Anxiety Inventory (Secondary), Mean, change score: Mindfulness Based Stress Reduction (MBSR) -1.40 +/- 4.51; Psychoeducational Supportive Care (PSC) -1.84 +/- 5.28 (p 0.71)

Adverse events

Time frame: during intervention (~9 weeks)

ArmDeathsSerious adverse eventsOther adverse events
Mindfulness Based Stress Reduction (MBSR)0/52 (0.0%)0/52 (0.0%)0/52 (0.0%)
Psychoeducational Supportive Care (PSC)0/51 (0.0%)0/51 (0.0%)1/51 (2.0%)

Other adverse events by term

TermOrgan systemMindfulness Based Stress Reduction (MBSR)Psychoeducational Supportive Care (PSC)
injury during session while performing unprescribed exerciseInjury, poisoning and procedural complications0/521/51

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

+Locations (1)

FacilityCityCountryStatus
VA San Diego Healthcare SystemSan Diego, CaliforniaUnited States

+Study documents

+Investigators

My Notes