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)
【저자키워드】 COVID-19, prevention, RCT, emergency department, Terminated study, Intrusive memories, Psychological trauma, Behavioural intervention, 【초록키워드】 Treatment, randomised controlled trial, COVID-19 pandemic, risk, Intervention, Symptom, outcome, virus, memory, Patient, Follow-up, recruitment, information, patients, trauma, attrition, cognitive, Participants, enrolment, limitation, Host, Effect, limitations, objective, face-to-face contact, Randomly, researchers, Result, required, reduced, condition, prevented, Swedish, presenting, 1:1, 【제목키워드】 Randomized controlled trial, Intervention, memory, Patient, trauma, Emergency, cognitive, Prevent,