- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02705586
Video Based Mindfulness Based Stress Reduction (vMBSR)
October 7, 2019 updated by: Amie Hiller, MD, Oregon Health and Science University
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Portland, Oregon, United States, 97239
- VA Portland Health Care System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: only one arm - open label study
2 hour video based mindfulness-based stress reduction class once a week for 10 weeks.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary Cortisol Levels (Pre- and Post-) Mindfulness-Based Stress Reduction Program
Time Frame: Baseline to 12 weeks
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Enzyme-linked immunoassay salivary cortisol levels (ng/mL) taken prior to Mindfulness-Based Stress Reduction will be compared to samples taken after the intervention.
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Baseline to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Amie L Hiller (Peterson), MD, VA Porltand Health Care system
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
March 7, 2016
First Submitted That Met QC Criteria
March 7, 2016
First Posted (Estimate)
March 10, 2016
Study Record Updates
Last Update Posted (Actual)
October 31, 2019
Last Update Submitted That Met QC Criteria
October 7, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15421
- 3825 (Other Identifier: VA Portland Health Care System)
- 5410 (Other Identifier: Oregon Clinical and Translational Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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