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临床试验/NCT05063825
NCT05063825已完成不适用

Understanding Reactions to Emotional Material in the Media During COVID-19 and the Connections to Cognitive Activities - Study 2

Uppsala University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2021年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
98
试验地点
1
主要终点
Number of intrusive memories related to the trauma film

研究概览

简要总结

This second feasibility study aims to adapt a protocol usually run in the laboratory in the Psychology Department for healthy participants (including the trauma film paradigm (James et al., 2016) and a simple cognitive task intervention) to remote (online) delivery. The motivation for this was restrictions to running in person laboratory experiments during the COVID-19 pandemic.

Non-clinical participants will view film footage with COVID-19 related and potentially traumatic content (e.g. of seriously ill or dying patients in hospitals). Following film viewing, participants will be randomly allocated to either the experimental condition (simple cognitive task intervention, i.e. a memory cue followed by playing the computer game "Tetris" with mental rotation instructions) or the control condition (attention placebo, i.e., a memory cue followed by listening to a podcast for a similar duration). Any intrusive memories induced by the film (analogue trauma) will be monitored in a daily diary. It is predicted that the film (analogue trauma) will generate intrusive memories. If intrusive memories are generated, then it is predicted that participants in the experimental condition will report fewer intrusive memories related to the film (analogue trauma) during the following week than participants in the control condition.

The development of this paradigm may inform the future development of a simple technique to prevent intrusive memories e.g. after repeated media consumption related to the COVID-19 pandemic.

详细描述

This is a between-groups experimental study with non-clinical participants informed by prior laboratory work. It includes two sessions and a seven-day daily diary in between sessions. All study procedures will be delivered remotely rather than in a laboratory because of the COVID-19 pandemic as in an initial feasibility study (NCT04608097). The primary outcome is the number of intrusive memories related to the film (analogue trauma) recorded in a daily electronic diary during the following week (week 1).

Our first feasibility study (NCT04608097) suggests it may be possible to generate intrusions when delivering the trauma film paradigm protocol remotely (online rather than in an in person laboratory) but this might lead to more variability between participants than when the paradigm is delivered in an in person laboratory. One possible reason might be that people are less emotionally affected by the film in a remote (online) setting compared to when they are viewing it in a more controlled laboratory setting. In this second study we will therefore only include participants who rate distress related to the trauma film as 5 or more out of 10 (see also James et al., 2015 for average scores on film distress in an in person laboratory setting).

Our first feasibility work also suggests it may be harder to deliver an experimental intervention remotely using instruction videos with little experimenter interaction. To address this, while still keeping the remote (online) format, i.e. minimal experimenter input, we made some adaptations such as changing our digital materials e.g. film clips and film viewing instructions within the video.

The first aim of this study is to investigate if the film (analogue trauma) will generate intrusive memories. The second aim is, if intrusive memories are generated, to investigate if participants in the experimental condition will report fewer intrusive memories of the film (analogue trauma) than participants in the control condition.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-65
  • Fluent in spoken and written Swedish
  • Willing to watch a video containing emotional, distressing footage
  • Have access to an internet enabled smartphone/computer

排除标准

  • Have participated in a study in which similar stimuli were used
  • Currently receiving treatment for a mental health problem (e.g. depression, anxiety, ADHD, addiction), including psychological therapy, counselling or medication
  • Neurological illness (e.g., epilepsy)
  • Planning to undertake a stress-inducing examination (e.g. university examination or driving test) during the week of study participation.

结局指标

主要结局

Number of intrusive memories related to the trauma film

时间窗: Week 1

Number of intrusive memories related to the trauma film recorded by participants in a brief diary daily for 7 days.

次要结局

  • . Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-film intrusions(Week 1 follow-up)
  • COVID-19 preventative behaviors index (adapted)(Week 1 follow-up)
  • Visual recognition memory test(Week 1 follow-up)
  • Future Expectancy Scale(Week 1 follow-up)
  • Self-rated concentration disruption associated with intrusive memories(Week 1 follow-up)
  • Verbal recognition memory test(Week 1 follow-up)
  • Characteristics of intrusive trauma memories related to the trauma film(Week 1)
  • Intrusion questionnaire(Week 1 follow-up)
  • Time perspective questionnaire(Week 1 follow-up)
  • Self-rated functioning associated with intrusive memories(Week 1 follow-up)
  • Intrusion provocation task (IPT)(Week 1 follow-up)
  • Self-rated sleep ratings(Week 1 follow-up)
  • Future self questionnaire(Week 1 follow-up)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Holmes

Professor

Uppsala University

研究点 (1)

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