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Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study (MBSR)

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ClinicalTrials.gov Identifier: NCT03998462
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
To investigate the efficacy of Mindfulness-based Stress Reduction (MBSR),to improve HRQoL, cognition, and mood, as well as to determine the longevity of the treatment response in individuals with Parkinson's disease (PD).

Condition or disease Intervention/treatment Phase
Parkinson's Disease Mindfulness Based Stress Reduction Quality of Life Behavioral: Mindfulness Based Stress Reduction Radiation: Creative Education Care Not Applicable

Detailed Description:
Eligible study participants will be randomly assigned to one of two interventions: 1) Mindfulness Based Stress Reduction for Parkinson's disease; MBSR-PD or 2) Creative Education Care (CEC). Study visits may be held remotely, via online video format (Webex). Interventions are held within a group format consisting of approximately 6-10 individuals with PD. Groups will meet once per week for over a 9-week period. All participants will be administered a battery of neuropsychological tests to measure HRQoL, cognition (e.g., executive function, attention, memory), and mood (i.e., anxiety, depression, and apathy), as well as motor symptoms, disease severity, and mindfulness engagement/practice. Tests will be administered at baseline, 9 weeks (post-treatment), and 6- and 12-months (follow-up assessments) by an examiner blinded to group assignment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigator and Assessor are blinded to group assignment.
Primary Purpose: Treatment
Official Title: Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : November 1, 2024

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Mindfulness Based Stress Reduction
MBSR consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.
 Behavioral: Mindfulness Based Stress Reduction
MBSR consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.
Other Name: MBSR
Placebo Comparator: Creative Education Care
Creative Education Care consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.
 Radiation: Creative Education Care
Creative Education Care consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.
Other Name: control group


Outcome Measures
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Primary Outcome Measures :
  1. Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index [ Time Frame: 0-9 weeks and 0-62 weeks ]
    Parkinson's disease Quality of Life (self-report); range = 0-156. Higher scores = poorer quality of life.

  2. Change in Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test total score [ Time Frame: 0-9 weeks and 0-62 weeks ]
    Objective measure of executive function; range = 0-26; higher scores = better executive function

  3. Change in State-Trait Anxiety Inventory (STAI) total score [ Time Frame: 0-9 weeks and 0-62 weeks ]
    Measure of anxiety; range of possible scores from 20-80; "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).


Eligibility Criteria
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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of PD based on UK Brain Bank Criteria
  2. >40 years of age

Exclusion Criteria:

  1. Secondary causes of Parkinsonism (e.g. corticobasal degeneration, progressive supranuclear palsy, drug-induced parkinsonism)
  2. Other neurological conditions (e.g. stroke)
  3. Clinical diagnosis of dementia based on any previous neuropsychological testing
  4. Psychosis, antipsychotic treatment or treatment for substance abuse
  5. Uncorrected vision or hearing to adequately participate in the intervention
  6. Prior formal training in MBSR or regular current MBSR practice
  7. Recent or new participation in a psychological/behavioral treatment, such as Cognitive Behavioral Therapy (CBT)
  8. Active/current suicidal ideation
Contacts and Locations
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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): NCT03998462


Contacts
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Contact: Nicole M Whiteley, BS (858) 552-8585 ext 3517 Nicole.Whiteley@va.gov
Contact: Dawn M Schiehser, PhD Dawn.Schiehser@va.gov

Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Patricia A Franklin, AA BS    858-552-8585 ext 7441    patricia.franklin2@va.gov   
Principal Investigator: Dawn M. Schiehser, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Dawn M. Schiehser, PhD VA San Diego Healthcare System, San Diego, CA
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03998462    
Other Study ID Numbers: D3154-R
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Mindfulness
Parkinson's disease
Intervention
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases