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Completed

NCT Number: NCT04469049

MBCT 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.

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Key information

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 (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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

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. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Mount Zion Health Fund

Registry information

Official study title

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

Acronym: MBCT-PD-2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2020
Registry last updated
Oct 5, 2021

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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