search
Back to results

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

Primary Purpose

Parkinson's Disease, Mindfulness Based Stress Reduction, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Creative Education Care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Mindfulness, Parkinson's disease, Intervention

Eligibility Criteria

41 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mindfulness Based Stress Reduction

Creative Education Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
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
Objective measure of executive function; range = 0-26; higher scores = better executive function
Change in State-Trait Anxiety Inventory (STAI) total score
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).

Secondary Outcome Measures

Full Information

First Posted
June 24, 2019
Last Updated
June 5, 2023
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT03998462
Brief Title
Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study
Acronym
MBSR
Official Title
Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Mindfulness Based Stress Reduction, Quality of Life
Keywords
Mindfulness, Parkinson's disease, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator and Assessor are blinded to group assignment.
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Stress Reduction
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Creative Education Care
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Description
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 Type
Radiation
Intervention Name(s)
Creative Education Care
Other Intervention Name(s)
control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
Description
Parkinson's disease Quality of Life (self-report); range = 0-156. Higher scores = poorer quality of life.
Time Frame
0-9 weeks and 0-62 weeks
Title
Change in Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test total score
Description
Objective measure of executive function; range = 0-26; higher scores = better executive function
Time Frame
0-9 weeks and 0-62 weeks
Title
Change in State-Trait Anxiety Inventory (STAI) total score
Description
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).
Time Frame
0-9 weeks and 0-62 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of PD based on UK Brain Bank Criteria >40 years of age Exclusion Criteria: Secondary causes of Parkinsonism (e.g. corticobasal degeneration, progressive supranuclear palsy, drug-induced parkinsonism) Other neurological conditions (e.g. stroke) Clinical diagnosis of dementia based on any previous neuropsychological testing Psychosis, antipsychotic treatment or treatment for substance abuse Uncorrected vision or hearing to adequately participate in the intervention Prior formal training in MBSR or regular current MBSR practice Recent or new participation in a psychological/behavioral treatment, such as Cognitive Behavioral Therapy (CBT) Active/current suicidal ideation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley E Carrillo, BS
Phone
(858) 552-8585
Ext
5593
Email
ashley.carrillo@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Dawn M Schiehser, PhD
Email
Dawn.Schiehser@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn M. Schiehser, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161-0002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia A Franklin, AA BS
Phone
858-552-8585
Ext
7441
Email
patricia.franklin2@va.gov
First Name & Middle Initial & Last Name & Degree
Dawn M. Schiehser, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs