An interventional study of Mindfulness in Parkinson's Disease, sponsored by Oregon Health and Science University. Completed at 2 sites in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-31.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Supportive care
To evaluate the feasibility of a video based mindfulness intervention for stress reduction and to evaluate the cortisol response in persons with PD and their caregivers. The data from this project will be used for a future grant application of a stress reduction intervention in persons with PD.
Participants will be enrolled at the VA Portland and have a baseline assessment. The baseline will assess neurological disorders (including Parkinsonism) and current stress. All participants will attend 10 weeks of mindfulness based stress reduction (MBSR) through video feed on the Portland VA campus. During the week prior to the first class and the week after the last class, participants will complete questionnaires regarding stress, collect saliva samples, and, for the Parkinson's patient, monitor motor symptoms of PD using diaries and inertial sensors. A final visit will assess stress, neurological diseases, and Parkinsonism.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 13 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2 hour video based mindfulness-based stress reduction class once a week for 10 weeks.
Behavioral: Mindfulness
Mindfulness focuses on helping participants understand their personal reactions to stress, teaches skills that provide means to modify stress reactions, and promotes self-care and feelings of competence and mastery. In addition to weekly class sessions, participants are asked to do an hour of home practice the days that the class does not meet.
Also known as: Mindfulness Based Stress REduction
Salivary Cortisol Levels (Pre- and Post-) Mindfulness-Based Stress Reduction Program
Enzyme-linked immunoassay salivary cortisol levels (ng/mL) taken prior to Mindfulness-Based Stress Reduction will be compared to samples taken after the intervention.
Time frame: Baseline to 12 weeks
From March 2016 to May 2016, 8 Parkinson's disease veterans and their caregivers were recruited for the 10-week Mindfulness-Based Stress Reduction classes held at the VA Portland Health Care System in Portland, Oregon.
| Milestone | Only One Arm - Open Label Study |
|---|---|
| Started | 13 |
| Completed | 5 |
| Not completed | 8 |
| Withdrew: Health issues | 2 |
| Withdrew: Transportation difficulties | 5 |
| Withdrew: Vacation/planned absence | 1 |
Enzyme-linked immunoassay salivary cortisol levels (ng/mL) taken prior to Mindfulness-Based Stress Reduction will be compared to samples taken after the intervention.
| Concentration (ng/mL) | Only One Arm - Open Label Study |
|---|---|
| Salivary Cortisol Levels (Pre- and Post-) Mindfulness-Based Stress Reduction Program | -33.1 ± 41.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Only One Arm - Open Label Study | — | 0/9 (0%) | 0/9 (0%) |
Baseline visits completed on 13 participants; Parkinson's disease and caregivers. 4 individuals dropped out prior to class week 1 due to difficulty travelling to the VA/too busy to come to the VA weekly. Analysis on 13 (individuals - both Parkinson's disease and caregivers).
| Age, Continuous(years) | Only One Arm - Open Label Study |
|---|---|
| Mean | 71.7 ± 6.8 |
| Sex: Female, Male(Participants) | Only One Arm - Open Label Study |
|---|---|
| Female | 6 |
| Male | 7 |
| Region of Enrollment(Participants) | Only One Arm - Open Label Study |
|---|---|
| United States | 13 |
| Years of Formal Education(years) | Only One Arm - Open Label Study |
|---|---|
| Mean | 14.9 ± 2.5 |
| Montreal Cognitive Assessment (MoCA)(units on a scale) | Only One Arm - Open Label Study |
|---|---|
| Mean | 25.4 ± 2.2 |
| United Parkinsons Disease Rating Scale - Part III motor section (UPDRS)(units on a scale) | Only One Arm - Open Label Study |
|---|---|
| Mean | 26.6 ± 8.5 |
| Hoehn & Yahr(units on a scale) | Only One Arm - Open Label Study |
|---|---|
| Mean | 2.2 ± 0.3 |
| Perceived Stress Scale (PSS)(units on a scale) | Only One Arm - Open Label Study |
|---|---|
| Mean | 12.7 ± 7.5 |
4 further baseline measures are reported on the registry.
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University