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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT03998462
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
58
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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
  • Behavioral: Mindfulness Based Stress Reduction
  • Radiation: Creative Education Care
 N/A

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

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 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 Names:
  • 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 Names:
  • control group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index [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 [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 [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

    Criteria

    Ages Eligible for Study:
    41 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 VA San Diego Healthcare System, San Diego, CA San Diego California United States 92161

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Dawn M. Schiehser, PhD, VA San Diego Healthcare System, San Diego, CA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT03998462
    Other Study ID Numbers:
    • D3154-R
    First Posted:
    Jun 26, 2019
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Parkinson Disease

    Study Results

    No Results Posted as of Mar 24, 2022