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Randomized Controlled Trial
. 2023 Jul;28(7):2985-2994.
doi: 10.1038/s41380-023-02062-7. Epub 2023 Apr 26.

Treating intrusive memories after trauma in healthcare workers: a Bayesian adaptive randomised trial developing an imagery-competing task intervention

Affiliations
Randomized Controlled Trial

Treating intrusive memories after trauma in healthcare workers: a Bayesian adaptive randomised trial developing an imagery-competing task intervention

Varsha Ramineni et al. Mol Psychiatry. 2023 Jul.

Abstract

Intensive care unit (ICU) staff continue to face recurrent work-related traumatic events throughout the COVID-19 pandemic. Intrusive memories (IMs) of such traumatic events comprise sensory image-based memories. Harnessing research on preventing IMs with a novel behavioural intervention on the day of trauma, here we take critical next steps in developing this approach as a treatment for ICU staff who are already experiencing IMs days, weeks, or months post-trauma. To address the urgent need to develop novel mental health interventions, we used Bayesian statistical approaches to optimise a brief imagery-competing task intervention to reduce the number of IMs. We evaluated a digitised version of the intervention for remote, scalable delivery. We conducted a two-arm, parallel-group, randomised, adaptive Bayesian optimisation trial. Eligible participants worked clinically in a UK NHS ICU during the pandemic, experienced at least one work-related traumatic event, and at least three IMs in the week prior to recruitment. Participants were randomised to receive immediate or delayed (after 4 weeks) access to the intervention. Primary outcome was the number of IMs of trauma during week 4, controlling for baseline week. Analyses were conducted on an intention-to-treat basis as a between-group comparison. Prior to final analysis, sequential Bayesian analyses were conducted (n = 20, 23, 29, 37, 41, 45) to inform early stopping of the trial prior to the planned maximum recruitment (n = 150). Final analysis (n = 75) showed strong evidence for a positive treatment effect (Bayes factor, BF = 1.25 × 106): the immediate arm reported fewer IMs (median = 1, IQR = 0-3) than the delayed arm (median = 10, IQR = 6-16.5). With further digital enhancements, the intervention (n = 28) also showed a positive treatment effect (BF = 7.31). Sequential Bayesian analyses provided evidence for reducing IMs of work-related trauma for healthcare workers. This methodology also allowed us to rule out negative effects early, reduced the planned maximum sample size, and allowed evaluation of enhancements. Trial Registration NCT04992390 ( www.clinicaltrials.gov ).

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Conflict of interest statement

The study was funded by the Wellcome Trust (223016/Z/21/Z). JK is shareholder and director of P1vital Products Ltd which is the study sponsor and manufacturer of i-spero®. VR and LI are employed by P1vital Products Ltd. MBB is an adjunct member of the DMC. CS salary is partly funded by National Institute for Health Research (NIHR133788) and Medical Research Council (MR/S035753/1 and MR/X005070/1). TJ is supported by a grant from UK Medical Research Council (MC_UU_00002/14). EAH salary is part funded by Wellcome Trust (223016/Z/21/Z) via consultancy to P1vital Products Ltd. EAH is on the Board of Trustees of the MQ Foundation. EAH also receives funding from the Swedish Research Council, Rannís The Icelandic Research Fund, OAK foundation, The Lupina Foundation and AFA Försäkring. EAH developed the intervention approach and training in using it (Anenome™). EAH receives book royalties from Guildford Press and Oxford University Press, and receives occasional honoraria for conference keynotes and clinical workshops. All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1. Trial profile.
CONSORT diagram showing enrolment, allocation, and the analysis populations.
Fig. 2
Fig. 2. Boxplots for intrusive memory (IM) measures.
The midline of the boxplot is the median value, with the upper and lower limits of the box being the third and first quartile (75th and 25th percentile), and the whiskers covering 1.5 times the IQR. The dots depict outliers (each dot represents one participant that departed more than 1.5 times the IQR above the third quartile and below the first quartile). All outliers are included in this figure. A Baseline measure for each arm. Total number of IMs of traumatic events recorded by participants in a brief daily online intrusive memory diary for 7 days during the baseline week (i.e. run-in week) for both arms (black = delayed arm (control); n = 39: usual care for 4 weeks; yellow = immediate arm; n = 36: immediate access to the intervention following the baseline week: the intervention consisted of a cognitive task involving a trauma reminder-cue plus Tetris® computer gameplay using mental rotation plus symptom monitoring), showing that the two arms did not differ at baseline (i.e., before the intervention was provided to the immediate arm). B The primary outcome measure for each arm. Total number of IMs of traumatic events recorded by participants in a brief daily online intrusive memory diary for 7 days during week 4 for each arm (black = delayed arm (control); n = 39: usual care for 4 weeks; yellow = immediate arm; n = 36: immediate access to the intervention following the baseline week: the intervention consisted of a cognitive task involving a trauma reminder-cue plus Tetris® computer gameplay using mental rotation plus symptom monitoring), showing that the immediate arm had fewer IMs at week 4 compared to the delayed arm, and that the number of IMs for the immediate arm decreased between the baseline week and week 4.
Fig. 3
Fig. 3. Evidence progression.
Sequential Bayesian analyses showed that the evidence (BFlog, i.e., the logarithmically scaled Bayes factor) in favour of the hypothesis that the intervention caused a positive treatment effect rapidly increased from the point of the first Bayesian analysis (n = 20, raw Bayes factor = 1.27) to the point where on consultation with the DMC the study was concluded (n = 45, raw Bayes factor = 14,700) pending a round of testing of digital optimisations. The study completed with 86 randomised participants, 75 of which were analysed (black line), thus saving 64 participants compared to the original estimated sample size (n = 150).

References

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