| Registry | NCT03998462, acronym MBSR |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 107 (Actual) |
| Sponsor | VA Office of Research and Development (Fed) |
| Conditions | Parkinson's Disease |
| Interventions | Mindfulness Based Stress Reduction, Psychoeducational Supportive Care (Behavioral) |
| Dates | start 2020-01-01, primary completion 2024-11-01, completion 2024-11-01, first posted 2019-06-26, last updated 2025-11-18 |
| Locations | 1 site in United States |
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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).
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Active comparator | Behavioral: Mindfulness Based Stress Reduction | 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. |
| Psychoeducational Supportive Care (PSC) | Active comparator | Behavioral: Psychoeducational Supportive Care | 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. |
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
| Milestone | Mindfulness Based Stress Reduction (MBSR) | Psychoeducational Supportive Care (PSC) |
|---|---|---|
| Started | 52 | 51 |
| Completed | 40 | 45 |
| Not completed | 12 | 6 |
Time frame: during intervention (~9 weeks)
| Arm | Deaths | Serious adverse events | Other 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%) |
| Term | Organ system | Mindfulness Based Stress Reduction (MBSR) | Psychoeducational Supportive Care (PSC) |
|---|---|---|---|
| injury during session while performing unprescribed exercise | Injury, poisoning and procedural complications | 0/52 | 1/51 |
Limitations and caveats: Outcome measures were adjusted and/or modified in order to be administered online due to the COVID-19 pandemic.
| Facility | City | Country | Status |
|---|---|---|---|
| VA San Diego Healthcare System | San Diego, California | United States |