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Randomized Controlled Trial
. 2021 May 10;14(1):176.
doi: 10.1186/s13104-021-05572-1.

A simple cognitive task intervention to prevent intrusive memories after trauma in patients in the Emergency Department: A randomized controlled trial terminated due to COVID-19

Marie Kanstrup #  1   2 , Laura Singh #  3   4 , Katarina E Göransson  5   6 , Beau Gamble  7 , Rod S Taylor  8 , Lalitha Iyadurai  9 , Michelle L Moulds  10 , Emily A Holmes  11   7
Affiliations
Randomized Controlled Trial

A simple cognitive task intervention to prevent intrusive memories after trauma in patients in the Emergency Department: A randomized controlled trial terminated due to COVID-19

Marie Kanstrup et al. BMC Res Notes. .

Abstract

Objective: This randomised controlled trial (RCT) aimed to investigate the effects of a simple cognitive task intervention on intrusive memories ("flashbacks") and associated symptoms following a traumatic event. Patients presenting to a Swedish emergency department (ED) soon after a traumatic event were randomly allocated (1:1) to the simple cognitive task intervention (memory cue + mental rotation instructions + computer game "Tetris" for at least 20 min) or control (podcast, similar time). We planned follow-ups at one-week, 1-month, and where possible, 3- and 6-months post-trauma. Anticipated enrolment was N = 148.

Results: The RCT was terminated prematurely after recruiting N = 16 participants. The COVID-19 pandemic prevented recruitment/testing in the ED because: (i) the study required face-to-face contact between participants, psychology researchers, ED staff, and patients, incurring risk of virus transmission; (ii) the host ED site received COVID-19 patients; and (iii) reduced flow of patients otherwise presenting to the ED in non-pandemic conditions (e.g. after trauma). We report on delivery of study procedures, recruitment, treatment adherence, outcome completion (primary outcome: number of intrusive memories during week 5), attrition, and limitations. The information presented and limitations may enable our group and others to learn from this terminated study. Trial registration ClinicalTrials.gov: NCT04185155 (04-12-2019).

Keywords: Behavioural intervention; COVID-19; Emergency Department; Intrusive memories; Prevention; Psychological trauma; RCT; Terminated study.

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Conflict of interest statement

EAH reports serving on the board of trustees of the charity MQ: Transforming Mental Health but receives no remuneration for this role. EAH receives royalties from books and occasional fees for workshops and invited addresses; receives occasional consultancy fees from the Swedish agency for health technology assessment and assessment of social services. LI is on the British Association for Behavioural and Cognitive Psychotherapies Scientific Committee and via this role is funded to attend the Annual Conference. The other authors have no conflicts of interests to declare.

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CONSORT participant flow diagram
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References

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