Trial Outcomes & Findings for Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study (NCT NCT03998462)
NCT ID: NCT03998462
Last Updated: 2025-11-18
Results Overview
Parkinson's disease Quality of Life (PDQ-39); Total Score = 0-156; higher score = worse quality of life.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
107 participants
Primary outcome timeframe
pre- to post-intervention (0 to 9 weeks)
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
|
Overall Study
COMPLETED
|
40
|
45
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Technical Difficulties
|
1
|
2
|
Baseline Characteristics
Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study
Baseline characteristics by cohort
| Measure |
Mindfulness Based Stress Reduction (MBSR)
n=52 Participants
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)
n=51 Participants
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.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 7.44 • n=202 Participants
|
69.8 years
STANDARD_DEVIATION 8.3 • n=283 Participants
|
68.98 years
STANDARD_DEVIATION 7.895 • n=120 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=202 Participants
|
20 Participants
n=283 Participants
|
43 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=202 Participants
|
31 Participants
n=283 Participants
|
60 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic
|
46 Participants
n=202 Participants
|
48 Participants
n=283 Participants
|
94 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
6 Participants
n=202 Participants
|
3 Participants
n=283 Participants
|
9 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction (MBSR)
n=52 Participants
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)
n=51 Participants
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.
|
|---|---|---|
|
Parkinson's Disease Questionnaire-39
|
-1.03 change score
Standard Deviation 9.71
|
-3.04 change score
Standard Deviation 7.94
|
SECONDARY outcome
Timeframe: pre- to post-intervention (0 to 9 weeks)Test My Brain (TMB) Matrix Reasoning Test (MRT); Total Score = 0-36; higher score = better performance.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction (MBSR)
n=52 Participants
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)
n=51 Participants
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.
|
|---|---|---|
|
Matrix Reasoning Test
|
0.154 change score
Standard Deviation 6.54
|
1.04 change score
Standard Deviation 5.92
|
SECONDARY outcome
Timeframe: pre- to post-intervention (0 to 9 weeks)State-Trait Anxiety Inventory - Trait Subscale (STAI-Trait); 20-80; higher score = higher levels of anxiety.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction (MBSR)
n=52 Participants
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)
n=51 Participants
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.
|
|---|---|---|
|
State-Trait Anxiety Inventory
|
-1.40 change score
Standard Deviation 4.51
|
-1.84 change score
Standard Deviation 5.28
|
Adverse Events
Mindfulness Based Stress Reduction (MBSR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Psychoeducational Supportive Care (PSC)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mindfulness Based Stress Reduction (MBSR)
n=52 participants at risk
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)
n=51 participants at risk
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.
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|---|---|---|
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Injury, poisoning and procedural complications
injury during session while performing unprescribed exercise
|
0.00%
0/52 • during intervention (~9 weeks)
|
2.0%
1/51 • Number of events 1 • during intervention (~9 weeks)
|
Additional Information
Dr. Dawn Schiehser, Ph.D.
North Florida/South Georgia VA Healthcare System
Phone: 352-376-1611
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place