Clinical trial NCT05063825: Understanding Reactions to Emotional Material in the Media During COVID-19 - Study 2
Official title: Understanding Reactions to Emotional Material in the Media During COVID-19 and the Connections to Cognitive Activities - Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-clinical Participants
Intrusive Memories
Keywords: Digital intervention
Intrusive Memories
Trauma Film Paradigm
COVID-19
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of intrusive memories related to the trauma film
timeFrame: Week 1
Secondary outcomes:
measure: Characteristics of intrusive trauma memories related to the trauma film
timeFrame: Week 1
measure: Intrusion questionnaire
timeFrame: Week 1 follow-up
measure: . Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-film intrusions
timeFrame: Week 1 follow-up
measure: Self-rated functioning associated with intrusive memories
timeFrame: Week 1 follow-up
measure: Self-rated concentration disruption associated with intrusive memories
timeFrame: Week 1 follow-up
measure: Self-rated sleep ratings
timeFrame: Week 1 follow-up
measure: COVID-19 preventative behaviors index (adapted)
timeFrame: Week 1 follow-up
measure: Intrusion provocation task (IPT)
timeFrame: Week 1 follow-up
measure: Verbal recognition memory test
timeFrame: Week 1 follow-up
measure: Visual recognition memory test
timeFrame: Week 1 follow-up
measure: Time perspective questionnaire
timeFrame: Week 1 follow-up
measure: Future self questionnaire
timeFrame: Week 1 follow-up
measure: Future Expectancy Scale
timeFrame: Week 1 follow-up
Other outcomes:
measure: Number of unwanted/intrusive memories of COVID-19 media footage during the week before study participation
timeFrame: Day 1
measure: Negative mood ratings
timeFrame: Day 1 and Week 1 follow-up
measure: Post-trauma-film ratings
timeFrame: Day 1
measure: Hotspots related to the trauma film (memory cue) and their characteristics
timeFrame: Day 1
measure: Post-condition ratings
timeFrame: Day 1
measure: Demand ratings about conditions
timeFrame: Week 1 follow-up
measure: Perceived Awareness of the Research Hypothesis Scale
timeFrame: Week 1 follow-up
measure: Exposure to COVID-19 related media in the week of study participation
timeFrame: Week 1 follow-up
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Emily Holmes, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: James EL, Lau-Zhu A, Clark IA, Visser RM, Hagenaars MA, Holmes EA. The trauma film paradigm as an experimental psychopathology model of psychological trauma: intrusive memories and beyond. Clin Psychol Rev. 2016 Jul;47:106-42. doi: 10.1016/j.cpr.2016.04.010. Epub 2016 Apr 21.
citation: James EL, Bonsall MB, Hoppitt L, Tunbridge EM, Geddes JR, Milton AL, Holmes EA. Computer Game Play Reduces Intrusive Memories of Experimental Trauma via Reconsolidation-Update Mechanisms. Psychol Sci. 2015 Aug;26(8):1201-15. doi: 10.1177/0956797615583071. Epub 2015 Jul 1.