Clinical trial NCT04469049: MBCT for People With Parkinson's Disease and Caregivers
Official title: Mindfulness-based Cognitive Therapy for People With Parkinson's Disease and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Anxiety
Depression
Keywords: Parkinson's disease
Mindfulness-based intervention
Mindfulness-based cognitive therapy (MBCT)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Mount Zion Health Fund
First posted: 2020-07-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the MBCT intervention, however they will be separated in several distinct groups over time, due to MBCT protocol limitations.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in anxiety symptom severity
timeFrame: From pre- to post-MBCT 8 weeks later
measure: Change in depressive symptom severity
timeFrame: From pre- to post-MBCT 8 weeks later
Secondary outcomes:
measure: Change in mindfulness levels
timeFrame: From pre- to post-MBCT 8 weeks later
measure: Change in caregiver burden score (caregivers only)
timeFrame: From pre- to post-MBCT 8 weeks later
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Andreea L. Seritan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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