Understanding Reactions to Emotional Material in the Media During COVID-19 - Study 2
Primary Purpose
Non-clinical Participants, Intrusive Memories
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Simple cognitive task intervention
Attention placebo
Sponsored by

About this trial
This is an interventional basic science trial for Non-clinical Participants focused on measuring Digital intervention, Intrusive Memories, Trauma Film Paradigm, COVID-19
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.
Sites / Locations
- Uppsala University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Simple cognitive task intervention
Attention placebo
Arm Description
A memory cue followed by playing the computer game "Tetris" (on own smartphone) with mental rotation instructions for ca. 12 minutes.
A memory cue followed by listening to a podcast (on own smartphone) for ca. 12 minutes.
Outcomes
Primary Outcome Measures
Number of intrusive memories related to the trauma film
Number of intrusive memories related to the trauma film recorded by participants in a brief diary daily for 7 days.
Secondary Outcome Measures
Characteristics of intrusive trauma memories related to the trauma film
2 self-rated items measuring the level of distress and vividness associated with the intrusions related to the trauma film (11-point scales from 0 to 10) rated within the diary. High scores indicate higher level of distress/vividness.
Intrusion questionnaire
1 self-rated item measuring the frequency of intrusive/unwanted memories of the trauma film in the previous week on a 7-point scale (from "never" to "many times a day", with a follow-up question to specify the number if necessary). Unless the answer to item 1 is "never", 5 self-rated items measuring the characteristics of intrusive/unwanted memories in the previous week. The level of distress, nowness, reliving, disconnectedness and whether different triggers are associated with the intrusive/unwanted memories of the trauma film are measured on a 101-point scale (from 0 to 100). Higher scores indicate more intrusive/unwanted memories, higher levels of distress/nowness/reliving/ disconnectedness and a greater number of different triggers.
. Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-film intrusions
Self-report measure that assesses subjective distress after a traumatic event (with reference to the trauma film). Here we include the intrusion subscale (8 items). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed (subscale score ranges from 0 to 32). Higher scores indicate worse outcome.
Self-rated functioning associated with intrusive memories
A single bespoke item on impact on daily functioning associated with the intrusions from the trauma film rated on a 11- point scale (from 0 "none"; 5 "some"; 10 "extreme"). Higher scores indicate higher level of functional impairment.
Self-rated concentration disruption associated with intrusive memories
A single bespoke item measuring the level of concentration disruption associated with the intrusions from the trauma film (11 point scale from 0 to 10). High scores indicate higher level of concentration disruption.
Self-rated sleep ratings
Two self rated items: Item 1 measures the extent of being troubled by poor sleep (with reference to study event) on a 5-point scale (from not at all to very much), and item 2 measures the number of nights in the week with sleep problems on a 5-point scale (from 0-1 to 5-7 nights). Each 5-point scale is reverse scored (4 - 0) then summed. Possible total scores range from 0 - 8, with higher values indicative of better sleep.
COVID-19 preventative behaviors index (adapted)
Self-report measure assessing preventative behaviors during the covid-19 pandemic (adapted for Swedish student population). 12 items are rated on a 5-point scale ranging from 1 ("Extremely unlikely") to 5 ("Extremely likely"). Items are summed. 4 items are reverse scored. Higher sum scores indicate more preventative behaviors during the COVID-19 pandemic.
Intrusion provocation task (IPT)
In the Intrusion Provocation Task (IPT), participants are presented with neutral still images from the trauma film. Immediately afterwards for the next two minutes, they are allowed to think freely and report intrusions by pressing a button. The IPT intrusion score is calculated by the total frequency of intrusions (i.e. number of button presses), whilst higher values represent more intrusions.
Verbal recognition memory test
The verbal recognition memory test comprises a number of true/false written statements relating to the trauma film. Participants indicate true or false as to whether or not the written statement about the film they watched 7 days earlier is correct. The score is the sum of correct responses, a higher score indicating better verbal recognition memory of the trauma film.
Visual recognition memory test
The visual recognition memory test consists of static visual images - some are taken from throughout the film (different images from those used in the IPT), and some are unviewed images presented as filler. Images are presented individually and participants are instructed to view each image for 5 s. Participants indicate yes or no as to whether or not they recognize the image as being from the trauma film they watched 7 days earlier. The score is the sum of correct responses, a higher score indicating better visual recognition memory of the trauma film.
Time perspective questionnaire
8 self-report items (5-point scale from 1 to 5) measuring time perspective on three subscales: past perspective (items 3, 5, 7), present perspective (items 1, 8) and future perspective (items 2, 4, 6). Item scores for each subscale will be summed. Higher values indicate higher levels of past/present/future time perspective.
Future self questionnaire
Three free text response fields asking to imagine a future self identity in relation to social/occupational/other important situations. A single item measuring which of these future identities has been most affected by the COVID-19 pandemic. Then a free text response field to describe a mental image of this identity, 4 items measuring vividness
(1 "not vivid at all", 10 "very vivid"), positivity (1 "very negative", 10 "very positive"), regularity of rehearsal (1 "never", 10 "very regularly"), and likelihood (1 "not at all likely", 10 "very likely") of that image on a 10-point scale. 3 items measuring the perspective of viewing that mental image ("through own eyes" or "as if seeing oneself"), whether other people are in the image (if yes, how many), and how old one will be in the image. All items are answered in terms of how the image was before and after the COVID-19 pandemic. Free text response field asking how the COVID-19 pandemic affected the future identity image.
Future Expectancy Scale
Self-report measure that assesses expectancies about positive future life events. 10 items are rated regarding how likely it is that the event will happen in one's future on a 7-point scale ranging from 1 ("not at all likely") to 7 ("extremely likely"). Items are summed. Higher scores indicate more optimistic/positive future expectancies.
Full Information
NCT ID
NCT05063825
First Posted
September 30, 2021
Last Updated
December 22, 2021
Sponsor
Uppsala University
1. Study Identification
Unique Protocol Identification Number
NCT05063825
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-clinical Participants, Intrusive Memories
Keywords
Digital intervention, Intrusive Memories, Trauma Film Paradigm, COVID-19
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simple cognitive task intervention
Arm Type
Experimental
Arm Description
A memory cue followed by playing the computer game "Tetris" (on own smartphone) with mental rotation instructions for ca. 12 minutes.
Arm Title
Attention placebo
Arm Type
Placebo Comparator
Arm Description
A memory cue followed by listening to a podcast (on own smartphone) for ca. 12 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Simple cognitive task intervention
Intervention Description
A memory cue followed by playing the computer game "Tetris" (on own smartphone) with mental rotation instructions for ca. 12 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Attention placebo
Intervention Description
A memory cue followed by listening to a podcast (on own smartphone) for ca. 12 minutes.
Primary Outcome Measure Information:
Title
Number of intrusive memories related to the trauma film
Description
Number of intrusive memories related to the trauma film recorded by participants in a brief diary daily for 7 days.
Time Frame
Week 1
Secondary Outcome Measure Information:
Title
Characteristics of intrusive trauma memories related to the trauma film
Description
2 self-rated items measuring the level of distress and vividness associated with the intrusions related to the trauma film (11-point scales from 0 to 10) rated within the diary. High scores indicate higher level of distress/vividness.
Time Frame
Week 1
Title
Intrusion questionnaire
Description
1 self-rated item measuring the frequency of intrusive/unwanted memories of the trauma film in the previous week on a 7-point scale (from "never" to "many times a day", with a follow-up question to specify the number if necessary). Unless the answer to item 1 is "never", 5 self-rated items measuring the characteristics of intrusive/unwanted memories in the previous week. The level of distress, nowness, reliving, disconnectedness and whether different triggers are associated with the intrusive/unwanted memories of the trauma film are measured on a 101-point scale (from 0 to 100). Higher scores indicate more intrusive/unwanted memories, higher levels of distress/nowness/reliving/ disconnectedness and a greater number of different triggers.
Time Frame
Week 1 follow-up
Title
. Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-film intrusions
Description
Self-report measure that assesses subjective distress after a traumatic event (with reference to the trauma film). Here we include the intrusion subscale (8 items). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed (subscale score ranges from 0 to 32). Higher scores indicate worse outcome.
Time Frame
Week 1 follow-up
Title
Self-rated functioning associated with intrusive memories
Description
A single bespoke item on impact on daily functioning associated with the intrusions from the trauma film rated on a 11- point scale (from 0 "none"; 5 "some"; 10 "extreme"). Higher scores indicate higher level of functional impairment.
Time Frame
Week 1 follow-up
Title
Self-rated concentration disruption associated with intrusive memories
Description
A single bespoke item measuring the level of concentration disruption associated with the intrusions from the trauma film (11 point scale from 0 to 10). High scores indicate higher level of concentration disruption.
Time Frame
Week 1 follow-up
Title
Self-rated sleep ratings
Description
Two self rated items: Item 1 measures the extent of being troubled by poor sleep (with reference to study event) on a 5-point scale (from not at all to very much), and item 2 measures the number of nights in the week with sleep problems on a 5-point scale (from 0-1 to 5-7 nights). Each 5-point scale is reverse scored (4 - 0) then summed. Possible total scores range from 0 - 8, with higher values indicative of better sleep.
Time Frame
Week 1 follow-up
Title
COVID-19 preventative behaviors index (adapted)
Description
Self-report measure assessing preventative behaviors during the covid-19 pandemic (adapted for Swedish student population). 12 items are rated on a 5-point scale ranging from 1 ("Extremely unlikely") to 5 ("Extremely likely"). Items are summed. 4 items are reverse scored. Higher sum scores indicate more preventative behaviors during the COVID-19 pandemic.
Time Frame
Week 1 follow-up
Title
Intrusion provocation task (IPT)
Description
In the Intrusion Provocation Task (IPT), participants are presented with neutral still images from the trauma film. Immediately afterwards for the next two minutes, they are allowed to think freely and report intrusions by pressing a button. The IPT intrusion score is calculated by the total frequency of intrusions (i.e. number of button presses), whilst higher values represent more intrusions.
Time Frame
Week 1 follow-up
Title
Verbal recognition memory test
Description
The verbal recognition memory test comprises a number of true/false written statements relating to the trauma film. Participants indicate true or false as to whether or not the written statement about the film they watched 7 days earlier is correct. The score is the sum of correct responses, a higher score indicating better verbal recognition memory of the trauma film.
Time Frame
Week 1 follow-up
Title
Visual recognition memory test
Description
The visual recognition memory test consists of static visual images - some are taken from throughout the film (different images from those used in the IPT), and some are unviewed images presented as filler. Images are presented individually and participants are instructed to view each image for 5 s. Participants indicate yes or no as to whether or not they recognize the image as being from the trauma film they watched 7 days earlier. The score is the sum of correct responses, a higher score indicating better visual recognition memory of the trauma film.
Time Frame
Week 1 follow-up
Title
Time perspective questionnaire
Description
8 self-report items (5-point scale from 1 to 5) measuring time perspective on three subscales: past perspective (items 3, 5, 7), present perspective (items 1, 8) and future perspective (items 2, 4, 6). Item scores for each subscale will be summed. Higher values indicate higher levels of past/present/future time perspective.
Time Frame
Week 1 follow-up
Title
Future self questionnaire
Description
Three free text response fields asking to imagine a future self identity in relation to social/occupational/other important situations. A single item measuring which of these future identities has been most affected by the COVID-19 pandemic. Then a free text response field to describe a mental image of this identity, 4 items measuring vividness
(1 "not vivid at all", 10 "very vivid"), positivity (1 "very negative", 10 "very positive"), regularity of rehearsal (1 "never", 10 "very regularly"), and likelihood (1 "not at all likely", 10 "very likely") of that image on a 10-point scale. 3 items measuring the perspective of viewing that mental image ("through own eyes" or "as if seeing oneself"), whether other people are in the image (if yes, how many), and how old one will be in the image. All items are answered in terms of how the image was before and after the COVID-19 pandemic. Free text response field asking how the COVID-19 pandemic affected the future identity image.
Time Frame
Week 1 follow-up
Title
Future Expectancy Scale
Description
Self-report measure that assesses expectancies about positive future life events. 10 items are rated regarding how likely it is that the event will happen in one's future on a 7-point scale ranging from 1 ("not at all likely") to 7 ("extremely likely"). Items are summed. Higher scores indicate more optimistic/positive future expectancies.
Time Frame
Week 1 follow-up
Other Pre-specified Outcome Measures:
Title
Number of unwanted/intrusive memories of COVID-19 media footage during the week before study participation
Description
1 self-rated item measuring the frequency of intrusive/unwanted memories of traumatic events related to COVID-19 or media consumption on COVID-19 in the previous week on a 7-point scale (from "never" to "many times a day", with a follow-up question to specify the number if necessary).
Time Frame
Day 1
Title
Negative mood ratings
Description
6 visual analogue scale ratings measuring how sad, hopeless, depressed, fearful, horrified and anxious participants feel "right at this very moment" on a scale from 1 "not at all" to 10 "extremely" assessed before and after film viewing and after completing the experimental or control condition task as well as in the beginning of session 2 (Week 1 follow- up). Rating are summed yielding a composite negative mood score, with higher scores indicating higher negative mood.
Time Frame
Day 1 and Week 1 follow-up
Title
Post-trauma-film ratings
Description
4 rating scales measuring how distressing participants found the trauma film, how much attention they paid to the film, how personally relevant the film was for them and how much they looked away from the film on a 11-point scale from 0 "not at all" to 10 "extremely".
Time Frame
Day 1
Title
Hotspots related to the trauma film (memory cue) and their characteristics
Description
6 free text response fields in which participants are asked to list the images/moments of the trauma film that were worst for them with a brief description. This list is part of the memory cue procedure in the experimental/control condition. For each hotspot, 2 self-rated items measuring the level of distress and vividness associated with the hotspot (11-point scales from 0 to 10). High scores indicate higher level of distress/vividness.
Time Frame
Day 1
Title
Post-condition ratings
Description
4 rating scales measuring how entertaining/difficult/distracting participants found the task they were doing in the experimental/control condition and how much attention they paid to the task they were doing in the experimental/ control condition on a 11-point scale from 0 "not at all" to 10 "extremely".
Time Frame
Day 1
Title
Demand ratings about conditions
Description
2 items measuring to which extent participants believe that playing Tetris/listening to a podcast after watching a distressing film increases or decreases intrusive memories of the film on a 21-point scale from -10 (extreme decrease), 0 (no effect), to 10 (extreme increase).
Time Frame
Week 1 follow-up
Title
Perceived Awareness of the Research Hypothesis Scale
Description
4 items measuring to which extent participants agree to statements about being aware of the purpose of the study on a 7-point scale from 1 "Do not agree at all" to 7 "Completely agree". Two items are reverse scored and then all items are summed. Higher scores indicate higher demand effects.
Time Frame
Week 1 follow-up
Title
Exposure to COVID-19 related media in the week of study participation
Description
5 items measuring the number of hours (0-11 or more) per day during the previous week that participants consumed COVID-19 related media content on TV, radio, newspaper, online news, or social media.
Time Frame
Week 1 follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Holmes, Prof
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
27289421
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.
Results Reference
background
PubMed Identifier
26133572
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.
Results Reference
background
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Understanding Reactions to Emotional Material in the Media During COVID-19 - Study 2
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