Parkinson Disease, Anxiety, Depression
Conditions
Keywords
Parkinson's disease, Mindfulness-based intervention, Mindfulness-based cognitive therapy (MBCT)
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.
Interventions
MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.
Sponsors
National Parkinson Foundation
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Time spent practicing mindfulness | During MBCT group (8 week-period) | Number of minutes per week spent practicing mindfulness exercises |
Countries
United States
Outcome results
None listed