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出境医 / 临床实验 / Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study (MBSR)

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

Study Description
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
Arms and Interventions
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
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

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
Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date April 5, 2021
Actual Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date November 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2021)
  • 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.
  • 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
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • 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.
  • 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
  • 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).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study
Official Title  ICMJE Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Investigator and Assessor are blinded to group assignment.
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson's Disease
  • Mindfulness Based Stress Reduction
  • Quality of Life
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Mindfulness Based Stress Reduction
  • 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.
    Intervention: Radiation: Creative Education Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2019) 		88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2024
Estimated Primary Completion Date November 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 41 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicole M Whiteley, BS (858) 552-8585 ext 3517 Nicole.Whiteley@va.gov
Contact: Dawn M Schiehser, PhD Dawn.Schiehser@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998462
Other Study ID Numbers  ICMJE D3154-R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dawn M. Schiehser, PhD VA San Diego Healthcare System, San Diego, CA
PRS Account VA Office of Research and Development
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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