MBCT for People With Parkinson's Disease and Caregivers

Not Applicable

Completed

• Conditions: Parkinson Disease; Depression; Anxiety
• Interventions: Behavioral: Mindfulness-based cognitive therapy (MBCT)

• Registration Number: NCT04469049
• 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 (PD) and caregivers of people with PD.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Study Start: 2020-11-11
• Primary Completion: 2021-06-11
• Study Completion: 2021-06-11
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness-based cognitive therapy (MBCT)	Mindfulness-based cognitive therapy (MBCT)	All participants will receive the MBCT intervention, consisting of 8 90-minute weekly group sessions.

Primary Outcome Measures

Name	Time	Method
Change in anxiety symptom severity	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	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 Outcome Measures

Name	Time	Method
Change in mindfulness levels	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.
Change in caregiver burden score (caregivers only)	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.

Trial Locations

Locations (1)

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