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Completed

NCT Number: NCT03904654

Mindfulness-based Cognitive Therapy (MBCT) 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.

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Key information

Conditions

Parkinson Disease Anxiety Anxiety Disorders Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness-based cognitive therapy (MBCT)

Behavioral

MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. Time spent practicing mindfulness

    Time frame: During MBCT group (8 week-period)

    Number of minutes per week spent practicing mindfulness exercises

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Parkinson Foundation

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2019
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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