跳至主要内容
临床试验/NCT04386668
NCT04386668终止不适用

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

University College, London2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
80
试验地点
2
主要终点
Kessler Psychological Distress Scale (K10)

研究概览

简要总结

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.

详细描述

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.

研究设计

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

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

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

排除标准

  • 未提供

结局指标

主要结局

Kessler Psychological Distress Scale (K10)

时间窗: 1 week post-intervention

10-item self-report distress scale

次要结局

  • Perceived Stress Scale (PSS-10)(Immediately, 1 week and 8 weeks post-intervention)
  • Kessler Psychological Distress Scale (K10)(Immediately and 8 weeks post-intervention)
  • Pittsburgh Sleep Quality Index (PSQI)(Immediately, 1 week and 8 weeks post-intervention)
  • Self-compassion scale (SCS)(Immediately, 1 week and 8 weeks post-intervention)
  • UCLA Loneliness Scale (UCLA LS)(Immediately, 1 week and 8 weeks post-intervention)
  • Uptake of existing mental health services (MHS)(Immediately, 1 week and 8 weeks post-intervention)
  • Mood and meaning(Immediately after each writing session)
  • Acceptability(Immediately post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Let It Out (LIO) and COVID19: Testing an Online... | 临床试验