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BMC Psychiatry. 2019 Nov 8;19(1):351. doi: 10.1186/s12888-019-2283-4.

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.

Author information

1
Département de Psychiatrie adulte, boulevard de l'Hôpital, 75013, Paris, France.
2
Department of Psychiatry, McGill University, Montréal, Canada.
3
Département de Psychiatrie adulte, Hôpital Universitaire de la Pitié Salpêtrière, Assistance Publique - Hôpitaux de Paris, boulevard de l'Hôpital, 75013, Paris, France.
4
Unité de recherche clinique, EPS de Ville Evrard, G03, 5 rue du Dr Delafontaine, 93200, Saint-Denis, France.
5
Assistance Publique - Hôpitaux de Paris -, Hôtel-Dieu, 75004, Paris, France.
6
France CHRU de Lille, Pôle de Psychiatrie Médecine Légale et Santé en milieu Pénitentiaire, SCA-Lab CNRS UMR 9193, 59037 cedex, Lille, France.
7
CIC INSERM U802, CHU de Poitiers, Unité de recherche clinique intersectorielle en psychiatrie du Centre Hospitalier Henri Laborit, 86022, Poitiers, France.
8
Centre Hospitalier Sainte Anne, Service Hospitalo-Universitaire, Faculté de Médecine Paris Descartes, Université Paris Descartes, Paris, France.
9
Service de Psychiatrie, CHU de Bicêtre, HUPS, APHP 78, rue du général Leclerc, 94270, Le Kremlin Bicêtre, France.
10
CH Marne La Vallée, Service de Médecine Légale, 77420, Marne-La-Vallée, France.
11
Clinical Neuroscience Department Hospital Pasteur 1, France University of Côte d'Azur, 30 avenue de la voie, 06002 NICE cedex 1, Romaine, France.
12
Département de psychiatrie et de psychologie médicale de l'adulte, Hôpital universitaire Saint-Antoine, Université Pierre et Marie Curie, Paris VI - AP-HP, 184 rue du Faubourg-Saint-Antoine, 75012, Paris, France.
13
Pôle Paris 11 Les Hôpitaux de Saint Maurice, 12-14 rue Val d'Osne, 94410, St Maurice, France.
14
Service Hospitalo-universitaire, CH du Rouvray, 4 rue Paul Eluard, 76300, Sotteville-lès-Rouen, France.
15
unité Inserm U1079 Faculté de médecine et de pharmacie, 76000, Rouen, France.
16
ECEVE, UMR 1123 URCEco Ile de France Hôtel Dieu, 1 place du Parvis de Notre Dame, 75004, Paris, France.
17
Département de Psychiatrie adulte, boulevard de l'Hôpital, 75013, Paris, France. b.millet@aphp.fr.
18
Département de Psychiatrie adulte, Hôpital Universitaire de la Pitié Salpêtrière, Assistance Publique - Hôpitaux de Paris, boulevard de l'Hôpital, 75013, Paris, France. b.millet@aphp.fr.

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

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