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临床试验/NCT04378803
NCT04378803已完成不适用

Mindfulness Training for Older Adults During the COVID-19 Pandemic

University of Miami2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2020年5月13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
53
试验地点
2
主要终点
Change in mindfulness skills as measured by Five-Facet Mindfulness Questionnaire (5FMQ)

研究概览

简要总结

The purpose of this research study is to learn more about how mindfulness training may influence thinking and feeling.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
60 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who are between 60 and 95 years of age
  • Individuals who are fluent English speakers
  • Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have an Internet connection
  • Individuals who are willing and able to consent to participate in the study

排除标准

  • Individuals who are cognitively impaired and not independent in daily activities, such as the use of the telephone, preparing meals
  • Individuals with an active and untreated mental condition (e.g., Bipolar disorder, Major Depression) and/or hospitalization for psychological/mental health issues within the last month.

结局指标

主要结局

Change in mindfulness skills as measured by Five-Facet Mindfulness Questionnaire (5FMQ)

时间窗: Baseline to week 10

5FMQ is a 15-item questionnaire with 5 sub-scales: observing, describing, acting with awareness, non-judgmental inner experience, and non-reactivity. The score for each sub-scale ranges from 3 to 15, a higher score is indicative of greater mindfulness skills.

Change in mindfulness skills as measured by decentering - Experiences Questionnaire (EQ).

时间窗: Baseline to week 10

EQ Decentering is an 11-item sub-scale measuring various thoughts and experiences, and the tendency to distance from those. The decentering score ranges from 1 to 55, with a higher score indicating high level of decentering.

Change in psychological health as measured by Patient Health Questionnaire 4 items (PHQ4).

时间窗: Baseline to week 10

PHQ4 is an ultra-brief 4-item measure of depression and anxiety with the total score ranging from 0 to 12. Higher score indicates higher level of anxiety and depression.

Change in positive affect on psychological health as measured by the short variant of the Positive and Negative Affect Scale (PANAS).

时间窗: Baseline to week 10

The PANAS positive sub-scale includes 5 items with a score ranges from 5 to 25 with a higher score indicating a higher positive mood.

Change in negative affect on psychological health as measured by the short variant of the Positive and Negative Affect Scale (PANAS).

时间窗: Baseline to week 10

The PANAS negative sub-scale includes 5 items with a score ranges from 5 to 25 with a higher score indicating a higher negative mood.

Change in loneliness measured by the loneliness questions from the social isolation battery.

时间窗: Baseline to week 10

The 3 loneliness questions from the social isolation battery will be used to measure loneliness with each question has a score ranging from 1 to 3 and a higher score indicates more loneliness.

Change in loneliness measured by a loneliness question.

时间窗: Baseline to week 10

The loneliness question will be used to measure perceived loneliness with a score ranging from 1 to 7 and a higher score indicates more loneliness.

次要结局

  • Change in well-being as measured by the Experience of Intrusions Scale (EIS)(Baseline to week 10)
  • Change in attention(Baseline to week 10)
  • Change in well-being as measured by the Perseverative Thought Questionnaire (PTQ)(Baseline to week 10)
  • Change in well-being as measured by the short version of the perceived stress scale (PSS).(Baseline to week 10)
  • Change in well-being as measured by the PERMA-Profiler(Baseline to week 10)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ekaterina Denkova

Research Assistant Professor

University of Miami

研究点 (2)

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