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MBCT for People With Parkinson's Disease and Caregivers (MBCT-PD-2)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04469049
Recruitment Status : Not yet recruiting
First Posted : July 13, 2020
Last Update Posted : September 15, 2020
Sponsor:
Collaborator:
Mount Zion Health Fund
Information provided by (Responsible Party):
University of California, San Francisco

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 (PD) and caregivers of people with PD.

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 (PD) and mild-to-moderate depression and/or anxiety, as well as caregivers of people with PD. Several 8-week long MBCT groups will be held between September 2020 and May 2021, based on the adapted protocol. The MBCT intervention will consist of 90-minute weekly groups focused on teaching mindfulness techniques and ways to recognize cognitive patterns that can increase anxiety and/or depression. Participants will be recruited from the community, according to the eligibility criteria detailed below. For all participants, the 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. For caregivers, pre- and post-MBCT caregiver burden scores will be compared as well.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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 several 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 and Caregivers
Estimated Study Start Date : November 15, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness-based cognitive therapy (MBCT)
All participants will receive the MBCT intervention, consisting of 8 90-minute weekly group sessions.
Behavioral: Mindfulness-based cognitive therapy (MBCT)
MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.




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. Change in caregiver burden score (caregivers only) [ Time Frame: From pre- to post-MBCT 8 weeks later ]
    Change in AMA Caregiver Self-Assessment Questionnaire score. The scale score range is 0-16, with higher scores indicating higher caregiver burden.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Having a diagnosis of Parkinson's disease (PD) or parkinsonism, established by a neurologist, or being a caregiver of a person with PD or parkinsonism
  • Living in the San Francisco Bay Area
  • Being able and willing to attend 8 weekly 90-minute online group sessions (5-6:30 pm PST)
  • 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
  • For people with PD: severe motor fluctuations (less than 2 hours "on" time per day)
  • Pattern of engagement with health care that indicates low likelihood of completing an 8-week intervention.

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): NCT04469049


Contacts
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Contact: Sarah Wang, PhD 4153537885 sarah.wang@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Sarah Wang, PhD    415-353-7885    sarah.wang@ucsf.edu   
Principal Investigator: Andreea L Seritan, MD         
Sponsors and Collaborators
University of California, San Francisco
Mount Zion Health Fund
Investigators
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Principal Investigator: Andreea L. Seritan, MD University of California, San Francisco
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: NCT04469049    
Other Study ID Numbers: MZHF_20200962
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: September 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
Neurodegenerative Diseases