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临床试验/NCT02789982
NCT02789982已完成3 期

Using Reconsolidation Blockade to Treat Trauma Related Disorders After Paris Attacks: an Effectiveness Study

Assistance Publique - Hôpitaux de Paris20 个研究点 分布在 2 个国家目标入组 364 人开始时间: 2016年5月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
364
试验地点
20
主要终点
Medical resources use

研究概览

简要总结

The purpose of this study is: (1) to examine the effectiveness of reconsolidation blockade as a treatment for trauma-related disorders, (2) to evaluate the feasibility of implementing this new treatment on a large scale in a short delay. This clinical trial as been set up in response to the Paris attacks to increase treatment capacity of the AP-HP (Assistance Publique des Hopitaux de Paris) hospital network.. Reconsolidation blockade will be compared to treatment as usual (TAU), on symptoms reduction after 6 weeks of treatment. In order to measure effectiveness and cost-utility, socioeconomic measures, quality of life and social functioning outcomes will be measured pre- and post-treatment as well as 3 and 12 months after study enrollment.

详细描述

The November 13th Paris attacks were the most violent and devastating events to occur in France since World War II. A large number of persons are likely to develop PTSD or trauma-related disorders, especially victims directly involved, their families, as well as the the first responders. In this context, there is an urgent need to enhance treatment resources. Psychotherapy is known to be effective but it is costly, and require qualified professionals. Pharmacotherapy (e.g., selective serotonin reuptake inhibitor,SSRIs) is also considered effective. However, side effects often lead patients to abandon their treatment. An alternative evidence-based intervention is the use of the β-adrenergic blocker propranolol used to interfere with the reconsolidation of a recalled traumatic memory, so as to reduce its strength over time. This clinical trial will evaluate the effectiveness and cost-utility of reconsolidation blockade compared to treatment as usual. The study involves four assessments: pre- and post-treatment and 13 weeks and 1 year follow up. The outcome measures include: PTSD symptoms, socioeconomic variables, quality of life and social functioning measures. The investigators hypothesize that all patients will improve. However, patients receiving reconsolidation blockade will recover faster than treatment as usual. Finally, investigators hypothesize that reconsolidation blockade will be well accepted both by the professionals and the patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 16 years or older
  • Suffer from PTSD, adjustment disorders or other specified trauma- and stressor-related disorder
  • PTSD Checklist - Specific (PCL-S) > 44
  • Clinical Global Impression (CGI) > 3
  • Informed Consent Form signed
  • Fluency in French

排除标准

  • Reconsolidation blockade group:
  • Resting systolic blood pressure < 100 mm Hg
  • Resting heart rate < 55 beats per minute
  • EKG significantly abnormal
  • Medical contraindication to use propranolol
  • Current use of medication that involve potentially dangerous interactions with propranolol
  • Previous adverse reaction to a β-adrenergic blocker
  • Current use of a β-adrenergic blocker
  • Patients taking psychotropic drugs which may interact with propranolol will be examined on a case-by-case basis
  • Both groups:
  • Subject under legal protection
  • Bipolar or psychotic disorder
  • Head trauma for less than one year or with clinical symptoms and neurological sequelae
  • Proven severe suicide risk (Mini-S and clinical assessment)
  • Opioid addiction or current alcohol dependence
  • Patients using SSRI for less than 2 months
  • Absence of affiliation to National french social security system
  • Pregnant or breastfeeding woman or without effective contraception

研究组 & 干预措施

Reconsolidation blockade

Experimental

β-adrenergic blocker propranolol 1 mg / kg to each of the 6 treatment sessions

干预措施: β-adrenergic blocker propranolol (Drug)

Treatment as usual

Active Comparator

Treatment as usual like SSRIs, psychotherapy, ...

干预措施: Treatment as usual (Behavioral)

结局指标

主要结局

Medical resources use

时间窗: from baseline to 12 months follow-up

Costs, in Euros, related to healthcare utilization and work status are evaluated with the MEDico-Economic Questionnaire (MEDEC) adapted from the Client Service Receipt Inventory in order to meet the specificity of the French Health system

Quality of life assessed by EQ-5D-5L Euroquol questionnaire

时间窗: at 12- months follow-up

The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated on five levels of severity. The levels of severity for each dimension ranges from no problems (1) to extreme problems/unable to perform (0)

The PTSD Checklist (PCL-S)

时间窗: change from baseline to 12 months follow-up

The PCL-S is a 17-item self-report scale assessing DSM-IV-TR PTSD symptoms in the past week from the perspective of the patient. The PSL-S range between 17 (no symptom) and 85 (maximum score)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (20)

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