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

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

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.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cognitive Behavioral Therapy* / methods
  • Female
  • France
  • History, 21st Century
  • Humans
  • Male
  • Memory Consolidation
  • Multicenter Studies as Topic
  • Non-Randomized Controlled Trials as Topic
  • Stress Disorders, Post-Traumatic* / etiology
  • Stress Disorders, Post-Traumatic* / therapy
  • Terrorism* / history
  • Terrorism* / psychology
  • Treatment Outcome
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT02789982