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临床试验/NCT03998462
NCT03998462已完成不适用

Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2020年1月1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
107
试验地点
2
主要终点
Parkinson's Disease Questionnaire-39

研究概览

简要总结

To investigate the efficacy of Mindfulness-based Stress Reduction (MBSR) to improve quality of life, cognition, and mood, as well as to determine the longevity of the treatment response in individuals with Parkinson's disease (PD).

详细描述

Eligible study participants with PD were randomly assigned to one of two 9-week remote (online) interventions: 1) Mindfulness Based Stress Reduction (MBSR) or 2) Psychoeducational Supportive Care (PSC). Intervention groups consisted of approximately 6-9 individuals and met weekly for 2.5 hours x 8 weeks and for 4 hours ("retreat") during week 7. All participants were remotely administered a battery of neuropsychological tests to measure quality of life, cognition (e.g., executive function, attention, memory), and mood (i.e., anxiety, depression, and apathy), as well as motor symptoms, disease severity, and mindfulness engagement/practice at pre-intervention (baseline), post-intervention (9 weeks), and at 6- and 12-months (follow-up assessments).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Investigator and Assessor are blinded to group assignment.

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of PD based on UK Brain Bank Criteria
  • 40 years of age or older

排除标准

  • Secondary causes of Parkinsonism (e.g. corticobasal degeneration, progressive supranuclear palsy, drug-induced parkinsonism)
  • Other neurological conditions (e.g. stroke)
  • Clinical diagnosis of dementia based on any previous neuropsychological testing
  • Psychosis, antipsychotic treatment or treatment for substance abuse
  • Uncorrected vision or hearing to adequately participate in the intervention
  • Prior formal training in MBSR or regular current MBSR practice
  • Inability to use a computer or technology for participation
  • Active/current suicidal ideation

结局指标

主要结局

Parkinson's Disease Questionnaire-39

时间窗: pre- to post-intervention (0 to 9 weeks)

Parkinson's disease Quality of Life (PDQ-39); Total Score = 0-156; higher score = worse quality of life.

Parkinson's Disease Questionnaire-39

时间窗: pre- to post-intervention (0 to 9 weeks)

Parkinson's disease Quality of Life (PDQ-39); Total Score = 0-156; higher score = worse quality of life.

次要结局

  • Matrix Reasoning Test(pre- to post-intervention (0 to 9 weeks))
  • State-Trait Anxiety Inventory(pre- to post-intervention (0 to 9 weeks))
  • Matrix Reasoning Test(pre- to post-intervention (0 to 9 weeks))
  • State-Trait Anxiety Inventory(pre- to post-intervention (0 to 9 weeks))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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