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

October 1, 2021 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

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:

  • 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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

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
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.
From pre- to post-MBCT 8 weeks later

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

Mount Zion Health Fund

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)

November 11, 2020

Primary Completion (Actual)

June 11, 2021

Study Completion (Actual)

June 11, 2021

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MZHF_20200962

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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