Parkinson's Disease
Conditions
Keywords
Movement disorders, Metabolic Stress
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMindfulness
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.
Sponsors
Portland VA Medical Center
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Parkinson's disease * Some Postural instability * Tremor in upper limb * Caregiver willing to also participate
Exclusion criteria
* No neurological disease * Cognitive deficits * Other neurological/psychological disorder * Completion of a stress reduction program in the last 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol Levels (Pre- and Post-) Mindfulness-Based Stress Reduction Program | Baseline to 12 weeks | Enzyme-linked immunoassay salivary cortisol levels (ng/mL) taken prior to Mindfulness-Based Stress Reduction will be compared to samples taken after the intervention. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
13 participants consented for the study. 4 withdrew after screening prior to the intervention due to the amount of travel to the Portland VA in the study.
Participants by arm
| Arm | Count |
|---|---|
| Only One Arm - Open Label Study 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. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Health Issues | 2 |
| Overall Study | Transportation Difficulties | 5 |
| Overall Study | Vacation/Planned Absence | 1 |
Baseline characteristics
| Characteristic | Only One Arm - Open Label Study |
|---|---|
| Age, Continuous | 71.7 years STANDARD_DEVIATION 6.8 |
| Hamilton Anxiety Rating Scale (HAM - A) | 10.8 units on a scale STANDARD_DEVIATION 7.6 |
| Hamilton Depression Rating Scale (HAM - D) | 7.2 units on a scale STANDARD_DEVIATION 6.7 |
| Hoehn & Yahr | 2.2 units on a scale STANDARD_DEVIATION 0.3 |
| Montreal Cognitive Assessment (MoCA) | 25.4 units on a scale STANDARD_DEVIATION 2.2 |
| Parkinson Disease Questionnaire - Carer (PDQ-Carer) | 13 units on a scale |
| Parkinson's Disease Questionnaire 39 (PDQ-39) | 37.4 units on a scale |
| Perceived Stress Scale (PSS) | 12.7 units on a scale STANDARD_DEVIATION 7.5 |
| Region of Enrollment United States | 13 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
| United Parkinsons Disease Rating Scale - Part III motor section (UPDRS) | 26.6 units on a scale STANDARD_DEVIATION 8.5 |
| Years of Formal Education | 14.9 years STANDARD_DEVIATION 2.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Only One Arm - Open Label Study | Salivary Cortisol Levels (Pre- and Post-) Mindfulness-Based Stress Reduction Program | -33.1 Concentration (ng/mL) | Standard Deviation 41.5 |