Parkinson's Disease
Conditions
Keywords
Mindfulness, Parkinson's disease, Intervention, Mindfulness Based Stress Reduction (MBSR), Mood, Cognition, Quality of Life
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).
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).
Interventions
BEHAVIORALMindfulness Based Stress Reduction
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.
BEHAVIORALPsychoeducational Supportive Care
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigator and Assessor are blinded to group assignment.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Based Stress Reduction (MBSR) 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. | 52 |
| Psychoeducational Supportive Care (PSC) 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. | 51 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Technical Difficulties | 1 | 2 |
| Overall Study | Withdrawal by Subject | 10 | 4 |
Baseline characteristics
| Characteristic | Mindfulness Based Stress Reduction (MBSR) | Psychoeducational Supportive Care (PSC) | Total |
|---|---|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 7.44 | 69.8 years STANDARD_DEVIATION 8.3 | 68.98 years STANDARD_DEVIATION 7.895 |
| Race/Ethnicity, Customized Ethnicity Hispanic | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Hispanic | 46 Participants | 48 Participants | 94 Participants |
| Sex: Female, Male Female | 23 Participants | 20 Participants | 43 Participants |
| Sex: Female, Male Male | 29 Participants | 31 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 51 |
| other Total, other adverse events | 0 / 52 | 1 / 51 |
| serious Total, serious adverse events | 0 / 52 | 0 / 51 |
Outcome results
Primary
Parkinson's Disease Questionnaire-39
Parkinson's disease Quality of Life (PDQ-39); Total Score = 0-156; higher score = worse quality of life.
Time frame: pre- to post-intervention (0 to 9 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Parkinson's Disease Questionnaire-39 | -1.03 change score | Standard Deviation 9.71 |
| Psychoeducational Supportive Care (PSC) | Parkinson's Disease Questionnaire-39 | -3.04 change score | Standard Deviation 7.94 |
p-value: 0.34Mixed Models Analysis
Secondary
Matrix Reasoning Test
Test My Brain (TMB) Matrix Reasoning Test (MRT); Total Score = 0-36; higher score = better performance.
Time frame: pre- to post-intervention (0 to 9 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Matrix Reasoning Test | 0.154 change score | Standard Deviation 6.54 |
| Psychoeducational Supportive Care (PSC) | Matrix Reasoning Test | 1.04 change score | Standard Deviation 5.92 |
p-value: 0.41Mixed Models Analysis
Secondary
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory - Trait Subscale (STAI-Trait); 20-80; higher score = higher levels of anxiety.
Time frame: pre- to post-intervention (0 to 9 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | State-Trait Anxiety Inventory | -1.40 change score | Standard Deviation 4.51 |
| Psychoeducational Supportive Care (PSC) | State-Trait Anxiety Inventory | -1.84 change score | Standard Deviation 5.28 |
p-value: 0.71Mixed Models Analysis