Paris MEM: a study protocol for an effectiveness and efficiency trial on the treatment of traumatic stress in France after the 2015-16 terrorist attacks

A Brunet, A Ayrolles, L Gambotti, R Maatoug, C Estellat, M Descamps, N Girault, K Kalalou, G Abgrall, F Ducrocq, G Vaiva, N Jaafari, M O Krebs, E Castaigne, I Hanafy, M Benoit, S Mouchabac, M C Cabié, O Guillin, F Hodeib, I Durand-Zaleski, B Millet, A Brunet, A Ayrolles, L Gambotti, R Maatoug, C Estellat, M Descamps, N Girault, K Kalalou, G Abgrall, F Ducrocq, G Vaiva, N Jaafari, M O Krebs, E Castaigne, I Hanafy, M Benoit, S Mouchabac, M C Cabié, O Guillin, F Hodeib, I Durand-Zaleski, B Millet

Abstract

Background: The Paris and Nice terrorist attacks affected a thousand of trauma victims and first-line responders. Because there were concerns that this might represent the first of several attacks, there was a need to quickly enhance the local capacities to treat a large number of individuals suffering from trauma-related disorders. Since Reconsolidation Therapy (RT) is brief, relatively easy to learn, well tolerated and effective, it appeared as the ideal first-line treatment to teach to clinicians in this context.

Methods: This study protocol is a two-arm non-randomized, multicenter controlled trial, comparing RT to treatment as usual for the treatment of trauma-related disorders. RT consists of actively recalling one's traumatic event under the influence of the ß-blocker propranolol, once a week, for 10-25 min with a therapist, over 6 consecutive weeks. This protocol evaluates the feasibility, effectiveness, and cost-utility of implementing RT as part of a large multi-center (N = 400) pragmatic trial with a one-year follow-up.

Discussion: Paris MEM is the largest trial to date assessing the efficiency of RT in the aftermath of a large-scale man-made disaster. RT could possibly reinforce the therapeutic arsenal for the treatment of patients suffering from trauma-related disorders, not only for communities in western countries but also worldwide for terror- or disaster-stricken communities.

Trial registration: Clinical Trials (ClinicalTrials.gov). June 3, 2016. NCT02789982.

Keywords: Cost-effectiveness trial; Post-traumatic stress disorder (PTSD); Reconsolidation; Terrorism.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flowchart
Fig. 2
Fig. 2
Evolution of the confidence interval according to the sample size and the delta PCL-S (green line: delta PCL-S above 30; red line: delta PCL-S below 30)

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