MBCT for People With Parkinson's Disease and Caregivers

University of California, San Francisco28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease Anxiety Depression

Interventions

Mindfulness-based cognitive therapy (MBCT)BEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Change in anxiety symptom severity

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.

Time frame: From pre- to post-MBCT 8 weeks later

Change in depressive symptom severity

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.

Time frame: From pre- to post-MBCT 8 weeks later

Secondary Outcomes

Change in mindfulness levels

Change in 15 item-Five Facet Mindfulness Questionnaire score. The scale score range is 0-75, with higher scores indicating higher mindfulness levels.

Time frame: From pre- to post-MBCT 8 weeks later

Change in caregiver burden score (caregivers only)

Change in AMA Caregiver Self-Assessment Questionnaire score. The scale score range is 0-16, with higher scores indicating higher caregiver burden.

Time frame: From pre- to post-MBCT 8 weeks later

Data from ClinicalTrials.gov

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