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

Not Applicable
Completed
Conditions
Depression
Anxiety
Parkinson Disease
Registration Number
NCT03904654
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Change in anxiety symptom severityFrom 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 severityFrom 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
NameTimeMethod
Change in mindfulness levelsFrom 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.

Time spent practicing mindfulnessDuring MBCT group (8 week-period)

Number of minutes per week spent practicing mindfulness exercises

Trial Locations

Locations (1)

University of California, San Francisco

🇺🇸

San Francisco, California, United States

University of California, San Francisco
🇺🇸San Francisco, California, United States

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