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临床试验/NCT04720404
NCT04720404已完成不适用

Mindful Prevention of Psychopathology in Healthcare Workers During the COVID-19 Crisis (COVID-19 MindPreP)

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2020年6月23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
201
试验地点
2
主要终点
Somatoform symptoms, Anxiety, Depression

研究概览

简要总结

The current study will be a randomized controlled trial (RCT) investigating an adapted online Mindfulness-Based Stress Reduction (MBSR) program versus daily online self-help mindfulness exercises, in preventing incident/prevalent psychopathology in healthcare workers allocated to work with COVID-19 patients. Outcome measures include depression, anxiety, somatoform symptoms, post-traumatic stress, insomnia, substance abuse, post-traumatic growth and positive mental health. The study also aims to explore possible working mechanisms such as perseverative thinking, mindfulness skills and self-compassion.

The study will have a follow-up duration of 7 months from baseline.

详细描述

Introduction With the rapid developments to anticipate and manage the ongoing COVID-19 pandemic, healthcare personnel is quickly reallocated to COVID-19 units. These people will experience substantial amounts of stress which has been shown to result in the development or increase of stress related disorders like psychological distress and psychopathology in 50-70%. Adaptive reconsolidation of stressful events is required for resilience against prolonged stress and prevent development and/or recurrence of psychopathology.

Mindfulness-based interventions (MBIs) are potent interventions with profitable results in many people with and without stress-related disorders. These interventions invite people to allow bodily sensations, thoughts and feelings in reaction to and in the aftermath of stressors and pay attention to them in a particular way: on purpose, in the present moment, and without judgment. The effectiveness of these interventions on stress reduction is now founded on a strong meta-analytical evidence base in symptom and stress-reduction in diverse clinical and non-clinical populations.

Mindfulness-based Stress Reduction (MBSR) is a specific stress-focused MBI. In healthcare professionals, MBSR training increased well-being, mindfulness skills, empathy and emotional stability and decreased burnout, anxiety, and depression. A randomized clinical trial showed that specifically residents with high baseline levels of emotional exhaustion benefitted from MBSR. Moreover, MBSR can be delivered effectively via interactive video-conferencing, which makes it suited to quickly support relatively large groups of healthcare workers.

Taken together that MBSR has beneficial effects in healthcare workers and is aimed at dealing with stress, this makes it a potentially useful intervention to prevent psychopathological sequela of the high-stress situations for healthcare workers inherent to the current COVID-19 outbreak. However, the effectiveness of an additional MBSR intervention in a severe crisis situation like the COVID-19 outbreak needs to be empirically investigated in a prospective study, before large scale implementation is advocated.

Aims The aim of the study is to investigate the effectiveness of an adapted online MBSR added to Support As Usual (SAU) versus daily self-help mindfulness exercises via a YouTube-channel (DMYT) + SAU on the incidence and prevalence of psychological distress and psychopathology (anxiety, depression, somatoform symptoms). In addition, we aim to decrease post-traumatic stress symptoms, insomnia, substance abuse and health-related costs more in the MBSR + SAU group. We also aim to improve the post-traumatic growth, positive mental health and health-related quality of life. Furthermore, we will investigate whether improving mindfulness skills and self-compassion and decreasing repetitive negative thinking may help reduce psychological distress (working mechanism).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes on psychiatric interview will be assessed by independent research assistants blind to condition. Participants will be instructed to avoid unblinding as much as possible.

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

  • Healthcare workers who are either currently or in past have been working directly with COVID-19 patients, e.g. on COVID-19 ward/intensive care unit.

排除标准

  • Impossibility to obtain a valid informed consent
  • Insufficient comprehension of the Dutch language
  • Inability to access the interactive videoconferencing

结局指标

主要结局

Somatoform symptoms, Anxiety, Depression

时间窗: Change between baseline and 7 months

Measured by the Patient Health Questionnaire - Somatoform symptoms, Anxiety, Depression (PHQ-SADS). The PHQ-SADS is a 31-item self-reported measure combining 3 questionnaires, the 9-item Patient Health Questionnaire (PHQ-9), the 7-item Generalized Anxiety Disorder scale (GAD-7) and the 15-item Patient Health Questionnaire (PHQ-15). The PHQ-9 is designed to measure depression in general medical and mental health settings. The GAD-7 measures severity of anxiety. The PHQ-15 is used to screen for somatization and monitoring somatic symptoms severity.

次要结局

  • Occurence of psychopathology(At 7-months follow-up)
  • Post-traumatic stress symptoms(At baseline, 1, 4 and 7 months)
  • Severity of insomnia(At baseline, 1, 4 and 7 months)
  • Alcohol use(At baseline, 1, 4 and 7 months)
  • Posttraumatic growth(At baseline, 1, 4 and 7 months)
  • Positive mental health(At baseline, 1, 4 and 7 months)
  • Health-related quality of life(At baseline, 1, 4 and 7 months)
  • Costs(At 7 months follow-up)

研究者

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

Anne Speckens

Professor Anne Speckens

Radboud University Medical Center

研究点 (2)

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