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

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
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
  • 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.

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 90-minute weekly 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.
Change in caregiver burden score (caregivers only)
Change in AMA Caregiver Self-Assessment Questionnaire score. The scale score range is 0-16, with higher scores indicating higher caregiver burden.

Full Information

First Posted
July 8, 2020
Last Updated
October 1, 2021
Sponsor
University of California, San Francisco
Collaborators
Mount Zion Health Fund
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1. Study Identification

Unique Protocol Identification Number
NCT04469049
Brief Title
MBCT for People With Parkinson's Disease and Caregivers
Acronym
MBCT-PD-2
Official Title
Mindfulness-based Cognitive Therapy for People With Parkinson's Disease and Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
June 11, 2021 (Actual)
Study Completion Date
June 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Mount Zion Health Fund

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 (PD) and caregivers of people with PD.
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.

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 several distinct groups over time, due to MBCT protocol limitations.
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (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 90-minute weekly 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
Change in caregiver burden score (caregivers only)
Description
Change in AMA Caregiver Self-Assessment Questionnaire score. The scale score range is 0-16, with higher scores indicating higher caregiver burden.
Time Frame
From pre- to post-MBCT 8 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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.
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
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MBCT for People With Parkinson's Disease and Caregivers

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