Clinical trial NCT03904654: Mindfulness-based Cognitive Therapy (MBCT) for People With Parkinson's Disease
Official title: Mindfulness-based Cognitive Therapy for People With Parkinson's Disease
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: National Parkinson Foundation
First posted: 2019-04-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the MBCT intervention, however they will be separated in 2 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Parkinson's disease or parkinsonism (established by a neurologist)
2. Living in the San Francisco Bay Area
3. Being able and willing to attend 8 weekly 90-minute group sessions
4. Mild-to-moderate anxiety: GAD-7 score ≤ 16
5. Mild-to-moderate depression: PHQ-9 score ≤ 18

Exclusion Criteria:

1. Severe anxiety: GAD-7 score \> 16
2. Moderately severe-to-severe depression: PHQ-9 score \> 18
3. Cognitive impairment: Montreal Cognitive Assessment (MoCA) score \< 24
4. Heavy alcohol or drug use
5. Severe psychosis
6. Active suicidal or homicidal ideation
7. Severe motor fluctuations (less than 2 hours "on" time per day)

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: Time spent practicing mindfulness
timeFrame: During MBCT group (8 week-period)
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:
citation: Chaudhuri KR, Healy DG, Schapira AH; National Institute for Clinical Excellence. Non-motor symptoms of Parkinson's disease: diagnosis and management. Lancet Neurol. 2006 Mar;5(3):235-45. doi: 10.1016/S1474-4422(06)70373-8.
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