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 (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.
Interventions
MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.
Sponsors
Mount Zion Health Fund
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 several distinct groups over time, due to MBCT protocol limitations.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
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. |
| 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. |
Countries
United States
Outcome results
None listed