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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05063825
Study type Interventional
Source Uppsala University
Contact
Status Completed
Phase N/A
Start date October 6, 2021
Completion date December 13, 2021

See also
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