Healthy ParticipantsNCT04608097
Understanding Reactions to Emotional Material in the Media During COVID-19
A study testing Simple cognitive task intervention in people with Healthy Participants and Intrusive Memories, run by Uppsala University at 1 site in Sweden.
Trial summary
This 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Intrusive Memories
- What is being tested?
- Simple cognitive task intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSweden
- Study dates
- 28 Oct 2020to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding Reactions to Emotional Material in the Media During COVID-19 and the Connections to Cognitive Activities
This 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.
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.
Read the detailed description
This is a between-groups experimental study with healthy participants informed by prior laboratory work. It includes two sessions and a seven-day daily diary in between sessions. In this feasibility study, for the first time all study procedures will be delivered remotely rather than in a laboratory because of the COVID-19 pandemic. 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).
The first aim 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.
- Conditions
- Healthy Participants, Intrusive Memories
- Being tested
- Simple cognitive task intervention, Attention Placebo
- Keywords
- Digital Intervention, Intrusive Memories, Trauma Film Paradigm, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple cognitive task interventionBehavioural
A memory cue followed by playing the computer game "Tetris" (on own smartphone) with mental rotation instructions for ca. 12 minutes.
Attention PlaceboBehavioural
A memory cue followed by listening to a podcast (on own smartphone) for ca. 12 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Simple cognitive task intervention | Experimental | A memory cue followed by playing the computer game "Tetris" (on own smartphone) with mental rotation instructions for ca. 12 minutes. Receives: Behavioral: Simple cognitive task intervention |
| Attention placebo | Placebo comparator | A memory cue followed by listening to a podcast (on own smartphone) for ca. 12 minutes. Receives: Behavioral: Attention Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1
Secondary outcomes (13)
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.
Measured: Week 1
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.
Measured: Week 1 follow-up
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.
Measured: Week 1 follow-up
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.
Measured: Week 1 follow-up
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.
Measured: Week 1 follow-up
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.
Measured: Week 1 follow-up
Behavior Change Questionnaire
7 bespoke self-report items assessing how much the trauma film affected related safety and avoidance behaviors from 0 (not at all) to 100 (extremely) (e.g. "I took greater care to keep a distance in public places"). A free text response field for other behaviors that were affected by the trauma film.
Measured: Week 1 follow-up
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.
Measured: Week 1 follow-up
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.
Measured: Week 1 follow-up
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.
Measured: Week 1 follow-up
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.
Measured: Week 1 follow-up
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.
Measured: Week 1 follow-up
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.
Measured: Week 1 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start28 Oct 2020
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Holmes, Uppsala University
- Investigators
- Emily Holmes, Prof, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608097
- Sponsor's protocol ID
- 2020-03991
- Status last verified
- Apr 2021
- First submitted
- 28 Oct 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27289421Singh L, Garate B, Hoppe JM, Holmes EA. Qualitative analysis of hotspots and intrusive memories after viewing an aversive film highlights their sensory and spatial features. Sci Rep. 2022 Apr 29;12(1):7049. doi: 10.1038/s41598-022-10579-0.
PubMed 35487945
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Reactions to Emotional Material in the Media During COVID-19 and the Connections to Cognitive Activities
- ClinicalTrials.gov ID
- NCT04608097
- Acronym / sponsor ID
- 2020-03991
- Conditions
- Healthy Participants, Intrusive Memories
- Keywords
- Digital Intervention, Intrusive Memories, Trauma Film Paradigm, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 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.
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 healthy participants informed by prior laboratory work. It includes two sessions and a seven-day daily diary in between sessions. In this feasibility study, for the first time all study procedures will be delivered remotely rather than in a laboratory because of the COVID-19 pandemic. 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).
The first aim 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple cognitive task intervention | Experimental | Behavioral: Simple cognitive task interventionA memory cue followed by playing the computer game "Tetris" (on own smartphone) with mental rotation instructions for ca. 12 minutes. |
| Attention placebo | Placebo comparator | Behavioral: Attention PlaceboA memory cue followed by listening to a podcast (on own smartphone) for ca. 12 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple cognitive task interventionA memory cue followed by playing the computer game "Tetris" (on own smartphone) with mental rotation instructions for ca. 12 minutes. | Behavioural | Simple cognitive task intervention |
| Attention PlaceboA memory cue followed by listening to a podcast (on own smartphone) for ca. 12 minutes. | Behavioural | Attention placebo |
Primary outcome
Number of intrusive memories related to the trauma film
Time frame: Week 1
Number of intrusive memories related to the trauma film recorded by participants in a brief diary daily for 7 days.
13 secondary outcomes
Characteristics of intrusive trauma memories related to the trauma film
Time frame: Week 1
Intrusion questionnaire
Time frame: Week 1 follow-up
Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-film intrusions
Time frame: Week 1 follow-up
Self-rated functioning associated with intrusive memories
Time frame: Week 1 follow-up
Self-rated concentration disruption associated with intrusive memories
Time frame: Week 1 follow-up
Self-rated sleep ratings
Time frame: Week 1 follow-up
Behavior Change Questionnaire
Time frame: Week 1 follow-up
Intrusion provocation task (IPT)
Time frame: Week 1 follow-up
Verbal recognition memory test
Time frame: Week 1 follow-up
Visual recognition memory test
Time frame: Week 1 follow-up
Time perspective questionnaire
Time frame: Week 1 follow-up
Future self questionnaire
Time frame: Week 1 follow-up
Future Expectancy Scale
Time frame: Week 1 follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Results publication: PubMed 27289421James 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.
- Derived from this study: PubMed 35487945Singh L, Garate B, Hoppe JM, Holmes EA. Qualitative analysis of hotspots and intrusive memories after viewing an aversive film highlights their sensory and spatial features. Sci Rep. 2022 Apr 29;12(1):7049. doi: 10.1038/s41598-022-10579-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Holmes, Prof principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple cognitive task intervention in people with Healthy Participants and Intrusive Memories, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intrusive memories related to the trauma film (time frame: Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04608097, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.