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临床试验/NCT04656626
NCT04656626已完成不适用

Brief Mindfulness Based Intervention for Front-Line Medical Staff in the COVID19 Pandemic to Improve Psychological Wellbeing, a Randomized Controlled Multicenter Trial

Imam Abdulrahman Bin Faisal University1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2020年7月7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
146
试验地点
1
主要终点
reduction of anxiety symptom severity

研究概览

简要总结

our aim is to evaluate the effectiveness of virtual brief mindfulness based interventions on psychological wellbeing, resiliency, and anxiety of frontline HCP to cope for (COVID19) stressors

详细描述

Our specific objectives are: To measure frontline HCP's level of anxiety, resilience, and how mindfulness based interventions affect anxiety and psychological resilience of HCP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

masking/ blindness was programmed in the system/website that was developed for this study; the participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment.

the system/ website For the sack of this study a new system was developed to be used for data collection. The system was designed as an electronic questioner with audio clips that is sent automatically to the participants' email and phones, where each participant receives their own special link.

the participants after responding to the pre intervention link will be automatically randomized by the system/website to intervention or control group.

the whole data collection and intervention process is automatic, virtual and blinded

入排标准

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

入选标准

  • COVID19 frontline health care providers namely, physicians, nurses and respiratory therapist at 2 main hospitals in the eastern province of KSA

排除标准

  • History of psychotic disorder,
  • Substance abuse or dependence within the last 6 months
  • Current severe neurotic disorder, severe depression or severe anxiety.
  • Concurrent psychotherapy.
  • Significant personality disorder

结局指标

主要结局

reduction of anxiety symptom severity

时间窗: 14 days

assessed using the (state trait anxiety-7 Item Scale); ranged from 10-40, higher score indicate more anxiety

change in the level of psychological resilience

时间窗: 14 days

assessed using the (Connor-Davidson Resilience Scale (CD-RISC)); score from 0-40, higher scores indicate more resilience

次要结局

  • and functional status(14 days)
  • mental wellbeing(14days)

研究者

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

Amani M AlQurni

Assistant Professor - Family Medicine

Imam Abdulrahman Bin Faisal University

研究点 (1)

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