跳至主要内容
临床试验/NCT03904654
NCT03904654已完成不适用

Mindfulness-based Cognitive Therapy for People With Parkinson's Disease

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
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.

详细描述

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.

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

入选标准

  • Diagnosis of Parkinson's disease or parkinsonism (established by a neurologist)
  • Living in the San Francisco Bay Area
  • Being able and willing to attend 8 weekly 90-minute group sessions
  • 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
  • Severe motor fluctuations (less than 2 hours "on" time per day)

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)
  • Time spent practicing mindfulness(During MBCT group (8 week-period))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验