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Clinical Trials/NCT03904654
NCT03904654
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country16 target enrollmentAugust 26, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University of California, San Francisco
Enrollment
16
Locations
1
Primary Endpoint
Change in anxiety symptom severity
Status
Completed
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 26, 2019
End Date
April 6, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Parkinson's disease or parkinsonism (established by a neurologist)
  • Living in the San Francisco Bay Area
  • Being able and willing to attend 8 weekly 90-minute group sessions
  • 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
  • Severe motor fluctuations (less than 2 hours "on" time per day)

Outcomes

Primary Outcomes

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.

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 Outcomes

  • Change in mindfulness levels(From pre- to post-MBCT 8 weeks later)
  • Time spent practicing mindfulness(During MBCT group (8 week-period))

Study Sites (1)

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