Video Based Mindfulness Based Stress Reduction (vMBSR)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson's Disease focused on measuring Movement disorders, Metabolic Stress
Eligibility Criteria
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
Sites / Locations
- Oregon Health & Science University
- VA Portland Health Care System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
only one arm - open label study
Arm Description
2 hour video based mindfulness-based stress reduction class once a week for 10 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02705586
First Posted
March 7, 2016
Last Updated
October 7, 2019
Sponsor
Oregon Health and Science University
Collaborators
Portland VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02705586
Brief Title
Video Based Mindfulness Based Stress Reduction
Acronym
vMBSR
Official Title
Video Based Mindfulness Based Stress Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Portland VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Movement disorders, Metabolic Stress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
only one arm - open label study
Arm Type
Experimental
Arm Description
2 hour video based mindfulness-based stress reduction class once a week for 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Other Intervention Name(s)
Mindfulness Based Stress REduction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Salivary Cortisol Levels (Pre- and Post-) Mindfulness-Based Stress Reduction Program
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amie L Hiller (Peterson), MD
Organizational Affiliation
VA Porltand Health Care system
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23939438
Citation
Armento ME, Stanley MA, Marsh L, Kunik ME, York MK, Bush AL, Calleo JS. Cognitive behavioral therapy for depression and anxiety in Parkinson's disease: a clinical review. J Parkinsons Dis. 2012;2(2):135-51. doi: 10.3233/JPD-2012-12080.
Results Reference
background
PubMed Identifier
24838316
Citation
Achey M, Aldred JL, Aljehani N, Bloem BR, Biglan KM, Chan P, Cubo E, Dorsey ER, Goetz CG, Guttman M, Hassan A, Khandhar SM, Mari Z, Spindler M, Tanner CM, van den Haak P, Walker R, Wilkinson JR; International Parkinson and Movement Disorder Society Telemedicine Task Force. The past, present, and future of telemedicine for Parkinson's disease. Mov Disord. 2014 Jun;29(7):871-83. doi: 10.1002/mds.25903. Epub 2014 May 17.
Results Reference
result
PubMed Identifier
11911234
Citation
Almeida DM, Wethington E, Kessler RC. The daily inventory of stressful events: an interview-based approach for measuring daily stressors. Assessment. 2002 Mar;9(1):41-55. doi: 10.1177/1073191102091006.
Results Reference
result
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Video Based Mindfulness Based Stress Reduction
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