NCT04608097

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 28, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

October 28, 2020

Last Update Submit

April 29, 2021

Conditions

Keywords

Digital InterventionIntrusive MemoriesTrauma Film ParadigmCOVID-19

Outcome Measures

Primary Outcomes (1)

  • 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.

    Week 1

Secondary Outcomes (13)

  • Characteristics of intrusive trauma memories related to the trauma film

    Week 1

  • Intrusion questionnaire

    Week 1 follow-up

  • Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-film intrusions

    Week 1 follow-up

  • Self-rated functioning associated with intrusive memories

    Week 1 follow-up

  • Self-rated concentration disruption associated with intrusive memories

    Week 1 follow-up

  • +8 more secondary outcomes

Other Outcomes (8)

  • Number of unwanted/intrusive memories of COVID-19 media footage during the week before study participation

    Day 1

  • Negative mood ratings

    Day 1 and Week 1 follow-up

  • Post-trauma-film ratings

    Day 1

  • +5 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Attention Placebo

Interventions

A memory cue followed by playing the computer game "Tetris" (on own smartphone) with mental rotation instructions for ca. 12 minutes.

Simple cognitive task intervention

A memory cue followed by listening to a podcast (on own smartphone) for ca. 12 minutes.

Attention placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, Sweden

Location

Related Publications (2)

  • 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.

  • Singh 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Emily Holmes, Prof

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2020

First Posted

October 29, 2020

Study Start

October 28, 2020

Primary Completion

March 12, 2021

Study Completion

March 12, 2021

Last Updated

April 30, 2021

Record last verified: 2021-04

Locations