Mindfulness-based Cognitive Therapy for People With Parkinson's Disease and Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in anxiety symptom severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in anxiety symptom severity
时间窗: 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
时间窗: 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.
次要结局
- Change in mindfulness levels(From pre- to post-MBCT 8 weeks later)
- Change in caregiver burden score (caregivers only)(From pre- to post-MBCT 8 weeks later)