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

May 19, 2020 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From pre- to post-MBCT 8 weeks later
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.
From pre- to post-MBCT 8 weeks later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From pre- to post-MBCT 8 weeks later
Time spent practicing mindfulness
Time Frame: During MBCT group (8 week-period)
Number of minutes per week spent practicing mindfulness exercises
During MBCT group (8 week-period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Parkinson Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 26, 2019

Primary Completion (ACTUAL)

April 6, 2020

Study Completion (ACTUAL)

April 6, 2020

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (ACTUAL)

April 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PF-CGP_19123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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