Back to resultsMindfulness-based Cognitive Therapy (MBCT) for People With Parkinson's Disease
Primary Purpose
Parkinson Disease, Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based cognitive therapy (MBCT)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Mindfulness-based intervention, Mindfulness-based cognitive therapy (MBCT)
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Parkinson's disease or parkinsonism (established by a neurologist)
- Living in the San Francisco Bay Area
- Being able and willing to attend 8 weekly 90-minute group sessions
- Mild-to-moderate anxiety: GAD-7 score ≤ 16
- Mild-to-moderate depression: PHQ-9 score ≤ 18
Exclusion Criteria:
- Severe anxiety: GAD-7 score > 16
- Moderately severe-to-severe depression: PHQ-9 score > 18
- Cognitive impairment: Montreal Cognitive Assessment (MoCA) score < 24
- Heavy alcohol or drug use
- Severe psychosis
- Active suicidal or homicidal ideation
- Severe motor fluctuations (less than 2 hours "on" time per day)
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindfulness-based cognitive therapy (MBCT)
Arm Description
All participants will receive the MBCT intervention, consisting of 8 60-minute consecutive weekly MBCT group sessions.
Outcomes
Primary Outcome Measures
Change in anxiety symptom severity
Change in Generalized Anxiety Disorder-7 item score (for participants with anxiety). The scale score range is 0-21, with higher scores indicating more severe anxiety.
Change in depressive symptom severity
Change in Patient Health Questionnaire-9 score (for participants with depression). The scale score range is 0-27, with higher scores indicating more severe depression.
Secondary Outcome Measures
Change in mindfulness levels
Change in 15 item-Five Facet Mindfulness Questionnaire score. The scale score range is 0-75, with higher scores indicating higher mindfulness levels.
Time spent practicing mindfulness
Number of minutes per week spent practicing mindfulness exercises
Full Information
NCT ID
NCT03904654
First Posted
April 3, 2019
Last Updated
May 19, 2020
Sponsor
University of California, San Francisco
Collaborators
National Parkinson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03904654
Brief Title
Mindfulness-based Cognitive Therapy (MBCT) for People With Parkinson's Disease
Official Title
Mindfulness-based Cognitive Therapy for People With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
April 6, 2020 (Actual)
Study Completion Date
April 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Parkinson Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to explore the feasibility and effectiveness of mindfulness-based cognitive therapy (MBCT) in reducing anxiety and/or depressive symptoms in people with Parkinson's disease.
Detailed Description
An adapted MBCT intervention will be offered to people with Parkinson's disease and mild-to-moderate depression and/or anxiety. Two 8-week long MBCT groups will be held between September 2019 and March 2020, based on the adapted protocol. Modifications will include shortening the traditional 120-minute to 90-minute format and performing mindful yoga from a chair, instead of a floor mat. Participants will be recruited from the community, according to the eligibility criteria detailed below. The participants' pre- and post-MBCT anxiety and/or depressive symptom severity and mindfulness levels (as measured with standardized, validated scales) will be compared, using a paired t-test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Anxiety, Depression
Keywords
Parkinson's disease, Mindfulness-based intervention, Mindfulness-based cognitive therapy (MBCT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive the MBCT intervention, however they will be separated in 2 distinct groups over time, due to MBCT protocol limitations.
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-based cognitive therapy (MBCT)
Arm Type
Experimental
Arm Description
All participants will receive the MBCT intervention, consisting of 8 60-minute consecutive weekly MBCT group sessions.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based cognitive therapy (MBCT)
Intervention Description
MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.
Primary Outcome Measure Information:
Title
Change in anxiety symptom severity
Description
Change in Generalized Anxiety Disorder-7 item score (for participants with anxiety). The scale score range is 0-21, with higher scores indicating more severe anxiety.
Time Frame
From pre- to post-MBCT 8 weeks later
Title
Change in depressive symptom severity
Description
Change in Patient Health Questionnaire-9 score (for participants with depression). The scale score range is 0-27, with higher scores indicating more severe depression.
Time Frame
From pre- to post-MBCT 8 weeks later
Secondary Outcome Measure Information:
Title
Change in mindfulness levels
Description
Change in 15 item-Five Facet Mindfulness Questionnaire score. The scale score range is 0-75, with higher scores indicating higher mindfulness levels.
Time Frame
From pre- to post-MBCT 8 weeks later
Title
Time spent practicing mindfulness
Description
Number of minutes per week spent practicing mindfulness exercises
Time Frame
During MBCT group (8 week-period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Parkinson's disease or parkinsonism (established by a neurologist)
Living in the San Francisco Bay Area
Being able and willing to attend 8 weekly 90-minute group sessions
Mild-to-moderate anxiety: GAD-7 score ≤ 16
Mild-to-moderate depression: PHQ-9 score ≤ 18
Exclusion Criteria:
Severe anxiety: GAD-7 score > 16
Moderately severe-to-severe depression: PHQ-9 score > 18
Cognitive impairment: Montreal Cognitive Assessment (MoCA) score < 24
Heavy alcohol or drug use
Severe psychosis
Active suicidal or homicidal ideation
Severe motor fluctuations (less than 2 hours "on" time per day)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreea L. Seritan, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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16488379
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Mindfulness-based Cognitive Therapy (MBCT) for People With Parkinson's Disease
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