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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03998462
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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: Psychoeducational/supportive 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) Psychoeducational/supportive care. Interventions are held within a group format consisting of approximately 6-8 individuals with PD. Groups will meet once per week for over a 8-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, 8 weeks (post-treatment), and 6- and 12-months (follow-up assessments) by an examiner blinded to group assignment.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mindfulness Based Stress Reduction
MBSR consists of 6-8 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 6-8 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: Psychoeducational/Supportive Care
Psychoeducational/Supportive care consists of 6-8 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.
Radiation: Psychoeducational/supportive care
Psychoeducational/Supportive Care consists of 6-8 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




Primary Outcome Measures :
  1. Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index [ Time Frame: 0-8 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: 0-8 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: 0-8 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).



Information from the National Library of Medicine

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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
  3. Hoehn and Yahr Rating Scale (HYRS) <5

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. Modified HYRS >4 (i.e. wheel chair bound or bedridden unless aided)
  7. Prior formal training in MBSR or regular current MBSR practice
  8. Active/current participation in a psychological/behavioral treatment, such as Cognitive Behavioral Therapy (CBT)
  9. Active/current suicidal ideation

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): 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

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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: January 22, 2020
Last Verified: January 2020
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