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Video Based Mindfulness Based Stress Reduction (vMBSR)

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ClinicalTrials.gov Identifier: NCT02705586
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : August 2, 2016
Sponsor:
Collaborator:
Portland VA Medical Center
Information provided by (Responsible Party):
Amie Hiller, MD, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Mindfulness Not Applicable

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  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Video Based Mindfulness Based Stress Reduction
Study Start Date : March 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: only one arm - open label study 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.
Other Name: Mindfulness Based Stress REduction




Primary Outcome Measures :
  1. Salivary Cortisol levels (Pre- and Post-) Mindfulness-Based Stress Reduction Program [ Time Frame: Baseline to 12 weeks ]
    Enzyme-linked immunoassay salivary cortisol levels taken prior to Mindfulness-Based Stress Reduction will be compared to samples taken after the intervention.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705586


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
VA Portland Health Care System
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Portland VA Medical Center
Investigators
Principal Investigator: Amie L Hiller (Peterson), MD VA Porltand Health Care system

Publications of Results:
Other Publications:
Responsible Party: Amie Hiller, MD, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02705586     History of Changes
Other Study ID Numbers: 15421
3825 ( Other Identifier: VA Portland Health Care System )
5410 ( Other Identifier: Oregon Clinical and Translational Institute )
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Amie Hiller, MD, Oregon Health and Science University:
Movement disorders
Metabolic Stress

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases