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Mindfulness-based Cognitive Therapy (MBCT) for People With Parkinson's Disease

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03904654
Recruitment Status : Completed
First Posted : April 5, 2019
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
National Parkinson Foundation
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Anxiety Depression Behavioral: Mindfulness-based cognitive therapy (MBCT) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Mindfulness-based Cognitive Therapy for People With Parkinson's Disease
Actual Study Start Date : August 26, 2019
Actual Primary Completion Date : April 6, 2020
Actual Study Completion Date : April 6, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mindfulness-based cognitive therapy (MBCT)
All participants will receive the MBCT intervention, consisting of 8 60-minute consecutive weekly MBCT group sessions.
 Behavioral: Mindfulness-based cognitive therapy (MBCT)
MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.


Outcome Measures
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Primary Outcome Measures :
  1. Change in anxiety symptom severity [ Time Frame: From pre- to post-MBCT 8 weeks later ]
    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.

  2. Change in depressive symptom severity [ Time Frame: From pre- to post-MBCT 8 weeks later ]
    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 :
  1. Change in mindfulness levels [ Time Frame: From pre- to post-MBCT 8 weeks later ]
    Change in 15 item-Five Facet Mindfulness Questionnaire score. The scale score range is 0-75, with higher scores indicating higher mindfulness levels.

  2. Time spent practicing mindfulness [ Time Frame: During MBCT group (8 week-period) ]
    Number of minutes per week spent practicing mindfulness exercises


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Parkinson's disease or parkinsonism (established by a neurologist)
  2. Living in the San Francisco Bay Area
  3. Being able and willing to attend 8 weekly 90-minute group sessions
  4. Mild-to-moderate anxiety: GAD-7 score ≤ 16
  5. Mild-to-moderate depression: PHQ-9 score ≤ 18

Exclusion Criteria:

  1. Severe anxiety: GAD-7 score > 16
  2. Moderately severe-to-severe depression: PHQ-9 score > 18
  3. Cognitive impairment: Montreal Cognitive Assessment (MoCA) score < 24
  4. Heavy alcohol or drug use
  5. Severe psychosis
  6. Active suicidal or homicidal ideation
  7. Severe motor fluctuations (less than 2 hours "on" time per day)
Contacts and Locations
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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): NCT03904654


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Parkinson Foundation
Investigators
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Principal Investigator: Andreea L. Seritan, MD University of California, San Francisco
More Information
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Publications:
Seritan AL, Ureste PJ, Duong T, Ostrem JL. Psychopharmacology for patients with Parkinson's disease and deep brain stimulation: Lessons learned in an academic center. Current Psychopharmacology 8(1):41-54, 2019 DOI: 10.2174/2211556007666180328142953
Cash TV, Ekouevi VS, Kilbourn C, Lageman SK. Pilot study of a mindfulness-based group intervention for individuals with Parkinson's disease and their caregivers. Mindfulness 7: 361-371, 2016

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03904654    
Other Study ID Numbers: PF-CGP_19123
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 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
Keywords provided by University of California, San Francisco:
Parkinson's disease
Mindfulness-based intervention
Mindfulness-based cognitive therapy (MBCT)
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
Synucleinopathies
Neurodegenerative Diseases