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Let It Out (LIO) and COVID19: Testing an Online Emotional Disclosure-based Intervention During the COVID19 Pandemic (LIO-C)

2020年10月6日 更新者:University College, London

Let It Out (LIO) and COVID19: a Randomised Controlled Trial of an Online Emotional Disclosure-based Intervention for Adults During the COVID19 Pandemic

A randomised controlled trial designed to test whether an online expressive writing intervention (LIO-C) can reduce distress for English-speaking adults during the global COVID19 pandemic.

Hypothesis: LIO-C will improve distress (as measured by K10) in adults at 1 week post-intervention compared to a neutral writing control during the COVID19 pandemic.

研究概览

详细说明

The world is currently experiencing unprecedented challenges caused by the global coronavirus (COVID19) pandemic. Many countries are enforcing measures to restrict movement of people to reduce the spread of the outbreak, including lock-downs, social distancing and self-isolation. These methods, although necessary to slow the spread of disease, will have negative effects on psychological well-being of large populations. Shortage of health care professionals and measures to restrict interpersonal contact means facilitated psychological interventions will not be feasible for many, at least during the height of the pandemic. There is therefore a need for self-directed psychological interventions that can be practically and quickly implemented online.

Emotional disclosure-based therapies, such as expressive writing (EW), hold potential as low-cost, easy to implement means of support, with minimal requirement for facilitation. In its original format, EW involved writing daily for 15-20 minutes for 3-4 days about a traumatic event. Since its development, it has been adapted in many ways, including writing about positive events and writing about stress from a compassionate stance. There is evidence that such interventions can provide significant psychological and physical benefits in healthy populations and reduce the effects of natural disasters on health and well-being. However, to our knowledge this form of psychological intervention has not been tested during a rapidly evolving crisis or pandemic.

The aim of this study is to test whether an online self-compassion and EW based intervention (LIO-C) can reduce the negative effects of the COVID19 pandemic on health and well-being. The intervention is based on an existing intervention, LIO, that we previously developed for use in advanced disease populations, in collaboration with clinical and health psychologists, and patient and public representatives. For this study, we have adapted the intervention for people living through the current COVID19 pandemic by altering the writing prompts, and translating the intervention to an online hub. As this is an unfacilitated intervention, the instructions involve writing from a compassionate stance to minimise any potential short term negative effects associated with writing about difficult experiences.

研究类型

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Kent
      • London、Kent、英国、TN14 6DW
        • University College London

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • English speaking adults over the age of 18
  • Able to read and write clearly in English

Exclusion Criteria:

  • None

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:LIO-C
Participants receive LIO-C writing intervention
Participants complete three online 20-minute writing sessions in response to prompts asking them to write about their experiences during the COVID19 pandemic from a self-compassionate perspective
其他名称:
  • expressive writing
  • emotional disclosure
  • expressive disclosure
  • therapeutic writing
安慰剂比较:Neutral writing control
Participants receive neutral writing control intervention
Participants complete three online 20-minute writing sessions in response to neutral writing prompts

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Kessler Psychological Distress Scale (K10)
大体时间:1 week post-intervention
10-item self-report distress scale
1 week post-intervention

次要结果测量

结果测量
措施说明
大体时间
Kessler Psychological Distress Scale (K10)
大体时间:Immediately and 8 weeks post-intervention
10-item self-report distress scale
Immediately and 8 weeks post-intervention
Perceived Stress Scale (PSS-10)
大体时间:Immediately, 1 week and 8 weeks post-intervention
Self-report stress scale
Immediately, 1 week and 8 weeks post-intervention
Pittsburgh Sleep Quality Index (PSQI)
大体时间:Immediately, 1 week and 8 weeks post-intervention
Self-report sleep scale
Immediately, 1 week and 8 weeks post-intervention
Self-compassion scale (SCS)
大体时间:Immediately, 1 week and 8 weeks post-intervention
Self-report self-compassion scale
Immediately, 1 week and 8 weeks post-intervention
UCLA Loneliness Scale (UCLA LS)
大体时间:Immediately, 1 week and 8 weeks post-intervention
Self-report loneliness scale
Immediately, 1 week and 8 weeks post-intervention
Uptake of existing mental health services (MHS)
大体时间:Immediately, 1 week and 8 weeks post-intervention
Self-report measure of MHS usage
Immediately, 1 week and 8 weeks post-intervention
Mood and meaning
大体时间:Immediately after each writing session
3-item, 7-point, Likert scale measuring how personal and meaningful participants' felt their writing was and their mood
Immediately after each writing session
Acceptability
大体时间:Immediately post-intervention
Via an online feedback form
Immediately post-intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Nuriye Kupeli、Marie Curie Palliative Care Research Department, UCL

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年5月26日

初级完成 (实际的)

2020年7月12日

研究完成 (实际的)

2020年8月31日

研究注册日期

首次提交

2020年5月12日

首先提交符合 QC 标准的

2020年5月12日

首次发布 (实际的)

2020年5月13日

研究记录更新

最后更新发布 (实际的)

2020年10月8日

上次提交的符合 QC 标准的更新

2020年10月6日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Fully anonymised participant data will be made available open access via ESRC data repository ReShare

IPD 共享访问标准

Open access

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

新冠肺炎的临床试验

Let It Out (LIO)-C的临床试验

3
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