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Suicide Risk 30 Days After a Potentially Traumatic Event in Patients Treated by a Medico-psychological Emergency Unit (SCAR)

23 мая 2022 г. обновлено: University Hospital, Grenoble

Suicide Risk Within 30 Days After a Potentially Traumatic Event (PTE) in Patients Treated by a Medico-psychological Emergency Unit. Prospective Cohort Study

The national french survey "Mental health in general population", showed that the risk of suicide was significantly increased during exposure to a potentially traumatic event (PTE), with an increasing gradient depending on the psychological impact. This included not only people suffering from post-traumatic stress disorder but also those confronted with PTE, presenting or having presented phenomena of reviviscence or at least an element of psychopathological impact. This risk could concern 30.2% of the population over the entire lifetime. Internationally, recent reviews of the literature tend to show that victims of interpersonal violence are more at risk of suicide (OR 1.99 95% CI: 1.73-2.28). Nevertheless, the literature remains heterogeneous, the definitions vague and the temporal proximity of the violence little taken into account. It is therefore a large-scale phenomenon that remains little explored.

To increase our knowledge in this area, the investigators will focus on patients treated by Emergency Medical Psychological Cells (CUMP), that is victims of disasters, accidents involving a large number of victims or events that may have significant psychological repercussions due to the circumstances surrounding them.

Обзор исследования

Статус

Еще не набирают

Подробное описание

The national french survey "Mental health in general population", showed that the risk of suicide was significantly increased during exposure to a potentially traumatic event (PTE), with an increasing gradient depending on the psychological impact. This included not only people suffering from post-traumatic stress disorder but also those confronted with PTE, presenting or having presented phenomena of reviviscence or at least an element of psychopathological impact. This risk could concern 30.2% of the population over the entire lifetime. Internationally, recent reviews of the literature tend to show that victims of interpersonal violence are more at risk of suicide (OR 1.99 95% CI: 1.73-2.28). Nevertheless, the literature remains heterogeneous, the definitions vague and the temporal proximity of the violence little taken into account. It is therefore a large-scale phenomenon that remains little explored.

To increase our knowledge in this area, the investigators will focus on patients treated by Emergency Medical Psychological Cells (CUMP), that is victims of disasters, accidents involving a large number of victims or events that may have significant psychological repercussions due to the circumstances surrounding them.

Estimate the prevalence of suicide risk 30 days after exposure to a potentially traumatic event, in people treated by a CUMP

The secondary objective aim to identify:

  1. The main psychiatric disorders at 30 days (depressive disorders, bipolar disorders, panic disorder, agoraphobia, social phobia, generalized anxiety, post-traumatic stress disorder, obsessive-compulsive disorder, disorder linked to the consumption of alcohol or other substances, psychotic disorders, eating disorders)
  2. The number of death by suicide 1 year after the trauma
  3. The incidence of suicide attempts 1 year after the trauma
  4. The incidence of suicidal ideation 1 year of trauma Prognostic factors of mortality by suicide, suicide attempts or suicidal ideation will be sought.

A number of 215 individuals would give a precision of ± 5% to a point estimate equal to 15% of the prevalence of suicide risk at 30 days. Assuming a 10% refusal rate to participate in the follow-up visit, this number should be increased to 240 patients.

This number of 215 patients would give 80% power to a logistic regression model of the binary primary endpoint (Y, risk of suicide at 30 days) on a binary independent variable (X) in the presence of a binary covariate (Z). to detect, with an alpha risk of 0.05, an odds ratio equal to 2.50. This number is calculated under the assumption of a baseline risk for the primary endpoint Y of 0.15, the independence of observations, a prevalence of the independent variable X of 50%, a prevalence the covariate Z of 50% and an odds ratio of the primary endpoint Y associated with the covariate Z of 1.50. This number is calculated for a two-tailed Wald test.

The investigators believe that their study could have a real impact on CUMP practices and suicide risk prevention. In fact, the CUMP represents an original device and the context of the emergency and support groups may overlook the risk of suicide for some patients. In addition, there is currently no systematic monitoring planned within the CUMPs. It is therefore an innovative and particularly topical subject that could change clinical practices but also the organization of the healthcare offer. Indeed, several treatment centers for psychotrauma are currently being deployed at the national level (including a center in Lyon, within the Hospices Civils de Lyon (HCL)) and an important work of coordination of treatment structures is in progress.

Тип исследования

Наблюдательный

Регистрация (Ожидаемый)

240

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Caroline Sanchez, PhD
  • Номер телефона: +33476634256
  • Электронная почта: csanchez5@chu-grenoble.fr

Места учебы

      • Chambéry, Франция
        • DELACHENAL Catherine
        • Контакт:
          • Catherine DELACHENAL, MD
      • Clermont-Ferrand, Франция
        • Geneste-Saelens
        • Контакт:
          • Julie GENESTE-SAELENS, MD
      • Lyon, Франция
        • VIGNAUD Philippe
        • Контакт:
          • Philippe VIGNAUD, MD
      • Montéléger, Франция
        • COURVOISIER Pierre
        • Контакт:
          • Pierre COURVOISIER, MD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Вероятностная выборка

Исследуемая популяция

Patients fulfilling the inclusion and non-inclusion criteria and having signed the consent will be included. Within 30 days (± 5 days), an appointment, by videoconference, will be made by the CUMP of the Grenoble center for the completion of the MINI scale and screening for suicidal behavior. This interview will be carried out either with the psychiatrist or the psychologist or with the psychiatric resident. If the patient does not answer, the trusted third party or the attending physician will be contacted by telephone in order to investigate the causes or to detect a possible death by suicide. The patient will be followed up one year after inclusion by telephone to detect the number of suicide attempts and/or death.

Описание

Inclusion Criteria:

  • Patient treated for the first time by a CUMP directly confronted with a potentially traumatic event (PTE) (with ou without a previous psychiatric history)
  • Patient affiliated with social welfare

Exclusion Criteria:

  • Age under 18
  • Not understanding French language.
  • Not having provided the contact details of a trusted third party and of the attending physician
  • Being homeless
  • Information on the exhibition unavailable (subjects recently arrived in France, foreign language, etc.)
  • A pathology requiring urgent medical treatment
  • Covered by articles L1121-5 to L1121-8 of the CSP (pregnant women, parturients, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care and adults subject to a measure of legal protection or unable to express their consent).

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Наблюдательные модели: Когорта
  • Временные перспективы: Перспективный

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Suicidal risk
Временное ограничение: 30 days
Absence or presence of the suicidal risk assessed using the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Depressive disorders
Временное ограничение: 30 days
Absence or presence of depressive disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Bipolar disorders
Временное ограничение: 30 days
Absence or presence of bipolar disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Panic disorder
Временное ограничение: 30 days
Absence or presence of panic disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Agoraphobia
Временное ограничение: 30 days
Absence or presence of agoraphobia used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Social phobia
Временное ограничение: 30 days
Absence or presence of social phobia used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Generalized anxiety
Временное ограничение: 30 days
Absence or presence of generalized anxiety used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Post-traumatic stress disorder
Временное ограничение: 30 days
Absence or presence of post-traumatic stress disorder used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Obsessive-compulsive disorder
Временное ограничение: 30 days
Absence or presence of obsessive-compulsive disorder used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Disorder linked to the consumption of alcohol or other substances
Временное ограничение: 30 days
Absence or presence of disorder linked to the consumption of alcohol or other substances used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Psychotic disorders
Временное ограничение: 30 days
Absence or presence of psychotic disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Eating disorders
Временное ограничение: 30 days
Absence or presence of eating disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Mortality by suicide
Временное ограничение: 365 days
Mortality by suicide after the psychological trauma (the cause of death is obtained from a trusted third party or from the attending physician)
365 days
Incidence of suicide
Временное ограничение: 365 days
Number of patients having presented at least one suicide attempt during the 365 days after the psychological trauma (declaration of the patient or, in his absence, of the declared trusted person or the general practitioner)
365 days
Incidence of suicidal ideation
Временное ограничение: 365 days
Number of patients declaring that they have presented suicidal ideation at least once during the 365 days after the psychological trauma (question yes / no)
365 days

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Следователи

  • Главный следователь: Helene Poncet, MD, CHU Grenoble Alpes, SAMU38 - CUMP

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Ожидаемый)

1 сентября 2022 г.

Первичное завершение (Ожидаемый)

30 августа 2023 г.

Завершение исследования (Ожидаемый)

30 апреля 2024 г.

Даты регистрации исследования

Первый отправленный

18 мая 2021 г.

Впервые представлено, что соответствует критериям контроля качества

18 мая 2021 г.

Первый опубликованный (Действительный)

24 мая 2021 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

27 мая 2022 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

23 мая 2022 г.

Последняя проверка

1 мая 2022 г.

Дополнительная информация

Термины, связанные с этим исследованием

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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