MBCT for People With Parkinson's Disease and Caregivers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindfulness-based Cognitive Therapy for People With Parkinson's Disease and Caregivers

Conditions
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Anxiety, Parkinson Disease, Depression

Intervention / Treatment
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* Behavioral: Mindfulness-based cognitive therapy (MBCT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based cognitive therapy (MBCT)<br>All participants will receive the MBCT intervention, consisting of 8 90-minute weekly group sessions. | Behavioral: Mindfulness-based cognitive therapy (MBCT)<br>* MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | From pre- to post-MBCT 8 weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | From pre- to post-MBCT 8 weeks later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Mindfulness-based intervention, Mindfulness-based cognitive therapy (MBCT)