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Predictive Factors of PTSD in Adults Admitted to an Emergency Service (ISSUE)

21 de octubre de 2019 actualizado por: Hospices Civils de Lyon

Identification of Biopsychosocial Factors Predictive of the Post-traumatic Stress Disorder Occurrence in Patients Admitted to the Emergencies After Trauma

After trauma or stress factor like death exposition, serious injuries or sexual violence, some patients may develop stress reaction characterized by the presence of various symptoms among different categories (reviviscence, negative humor, dissociates symptoms, occasion, hypervigilance). In the month following trauma, the investigators speak of acute stress reaction (ASR) when symptoms are present during at least three days. If symptoms are present one month after trauma, then it is a post-traumatic stress disorder (PTSD).

Among patients visiting emergency after latest trauma, quite a few is in acute stress reaction. However, this reaction is often incorrectly identified by healthcare team, due to lack of oriented medical examination, patients visiting about other complaints (pain, insomnia) and not expressing clearly the trauma context. Yet, it is know that acute stress reaction occurrence and existence of dissociate symptoms after trauma confrontation is considerably predictive of the eventual post-traumatic stress disorder occurrence.

The identification of risk population of post-traumatic stress disorder is not the subject of any particular structured procedure in emergency services while early care of these patients may allow limiting post-traumatic stress disorder occurrence and associate consequences. Previous works on the subject having exclusively targeted some trauma subgroups or some predictive factors subtypes, investigators propose here biopsychosocial global approach that can weight the impact of each parameters.

In this study, investigators aim at determining predictive biopsychosocial factors of the post-traumatic stress disorder occurrence at 3 months in patients visiting emergency after latest trauma (less than one month old) and identified as "high-risk" to develop post-traumatic stress disorder (moderate or high).

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

460

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Clermont-Ferrand, Francia, 63000
        • CHU Clermont - Hôpital G Montpied - Urgences Psychiatriques et Médecine d'urgence
      • Lyon, Francia, 69007
        • CH St Joseph St Luc - Urgences Psychiatriques et Médecine d'urgence
      • Lyon, Francia, 69432
        • Hôpital Edouard Herriot - Urgences Psychiatrique et Médecine d'urgence
      • Pierre-Bénite, Francia, 69310
        • Centre Hospitalier Lyon Sud - Urgences psychiatriques
      • Saint-Priest-en-Jarez, Francia, 42270
        • CHU St Etienne - Hôpital Nord - Urgences Psychiatriques

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Man or woman aged between 18 and 70
  • Admitted in an emergency service after a trauma less than one month old, defined by death exposition or death threat, serious injury or sexual violence, by one or several of the following;

    • Being directly exposed ;
    • Being direct witness of traumatic event that occurred to other people;
    • Hearing that traumatic event arrived to close family member or close friend. In the case of death penalty or death threat of a family member or a friend, events must have been violent or accidental.
    • Being exposed repeatedly or extremely to aversive characteristics of trauma events (for example: first line actors gathering human remains, cops exposed several times to kid sexual abuse explicit fact).
  • Written informed-consent
  • Affiliation to the French social security scheme or beneficiary of a similar scheme

Exclusion Criteria:

  • Patient not understanding French language
  • Patient under guardianship
  • Clinical instability making impossible the realization of questionnaires (for example: agitation, vital risk, disorders of consciousness…)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Patients having trauma
Adults patients having trauma in the month before visiting emergency will fill questionnaires
Questionnaires will be submitted to patients during their visit to emergency service and 3 months later to evaluate the prevalence of Post Traumatic Stress Disorder and to identify predictive biopsychosocial factors

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Post Traumatic Stress Disorder (PTSD) occurrence
Periodo de tiempo: At 3 months following admission to the emergency service

Presence or absence PTSD will be evaluated by the PCL-5 scale (PTSD Checklist for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders -5)).

The PCL-5 scale will be completed with patients during a phone interview with a psychologist or a psychiatrist.

The PCL-5 is a 20-item questionnaire that assesses the 20 DSM-5 symptoms of PTSD.

Patients will be asked to rate how bothered they have been by each item in the past 3-month on a 5-point Likert scale ranging from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely).

A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20).

Items are summed to provide a total score. The range is 0-80. A total score of 33 or higher signifies the likely presence of PTSD.

At 3 months following admission to the emergency service

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Prevalence of high risk patients to develop Post Traumatic Stress Disorder
Periodo de tiempo: 1 day (at admission to the emergency service)

The high risk of developing Post Traumatic Stress Disorder will be determined by the Impact of Event Scale-Revised (IES-R).

The IES-R is a 22-item self-report questionnaire that assesses subjective distress caused by traumatic events. The IES-R contains sub-scales for avoidance, intrusions and hyperarousal.

Patients will be asked to indicate how much they were distressed or bothered during the past seven days by each item.

Items are rated on a 5-point scale ranging from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely). The IES-R yields a total score ranging from 0 to 88.

A total IES-R score of over 34 signifies patient is at high risk to develop PTSD.

1 day (at admission to the emergency service)
Prevalence of moderate risk patients to develop Post Traumatic Stress Disorder
Periodo de tiempo: 1 day (at admission to the emergency service)

The moderate risk of developing Post Traumatic Stress Disorder will be determined by the Impact of Event Scale-Revised (IES-R).

The IES-R is a 22-item self-report questionnaire that assesses subjective distress caused by traumatic events. The IES-R contains sub-scales for avoidance, intrusions and hyperarousal.

Patients will be asked to indicate how much they were distressed or bothered during the past seven days by each item.

Items are rated on a 5-point scale ranging from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely). The IES-R yields a total score ranging from 0 to 88.

An IES-R score between 12 and 34 included signifies patient is at moderate risk to develop PTSD.

1 day (at admission to the emergency service)
Post Traumatic Stress Disorder incidence
Periodo de tiempo: At 3 months following admission to the emergency service
Presence of Post Traumatic Stress Disorder will be determined by the PCL-5 scale at 3 months following admission to the emergency service (primary outcome measure). Incidence is the rate of newly diagnosed patients of PTSD at 3 months.
At 3 months following admission to the emergency service
Dissociative experiences
Periodo de tiempo: At admission to the emergency service

Describe the patient dissociative disorders using the Questionnaire of Peritraumatic Dissociative Experiments score.

The Peritraumatic Dissociative Experiences Questionnaire (PDEQ) determines the presence and the intensity of the peritraumatic response experienced by the individual at the time of the traumatic event, and in the minutes and hours that followed.

The PDEQ in a 10-item test. Each item is scored from 1 (not at all true) to 5 (extremely true). The total score is the sum of all items. A score above 15 is indicative of significant dissociation.

At admission to the emergency service
Social consequences
Periodo de tiempo: At 3 months following admission to the emergency service

Describe Post Traumatic Stress Disorder impact on social life using the Social Support Questionnaire (SSQ6).

The Social Support Questionnaire 6 (SSQ6) is a 6-item questionnaire designed to measure two dimensions of social support: availability and satisfaction.

Each item is a question that solicits a two-part answer: Part 1 asks participants to list up nine people maximum available to provide support in each of 6 areas, and Part 2 asks participants to indicate how satisfied they are, in general, with these people.

Availability is scored by counting the total number of people for each item (max = 54), and satisfaction is scored by counting the total satisfaction scores for the 6 items (max = 36).

At 3 months following admission to the emergency service
Social consequences
Periodo de tiempo: At 3 months following admission to the emergency service
Describe PTSD impact on professional life by calculating the number of sick leave days over the 3 months
At 3 months following admission to the emergency service
Complications associated to Post Traumatic Stress Disorder
Periodo de tiempo: At 3 months following admission to the emergency service

Impact of the excessive drinking and alcohol using the Alcohol Use Disorders Identification Test (AUDIT) at 3 months.

The AUDIT is a 10-item screening tool that assesses alcohol consumption, drinking behaviors, and alcohol-related problems. Each item has a score ranging from 0 to 4.

Total scores of 7 or more in men, 6 or more in women are recommended as indicators of hazardous and harmful alcohol use.

At 3 months following admission to the emergency service
Complications associated to Post Traumatic Stress Disorder
Periodo de tiempo: At 3 months following admission to the emergency service

Impact of the nicotine dependence at 3 months using the Fagerström test. The Fagerström Test is a standard instrument for assessing the intensity of physical addiction to nicotine.

In scoring the Fagerstrom Test, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10.

A patient who scores between 0 and 2 is classified as no nicotine dependence; a score of 3 or 4 would be considered to have low dependence on nicotine, moderate dependence for a score of 5 or 6, high dependence for a score of 7 or 8, and very high dependence for a score of 8 or over.

At 3 months following admission to the emergency service
Complications associated to Post Traumatic Stress Disorder
Periodo de tiempo: At 3 months following admission to the emergency service

The severity of depressive symptoms at 3 months will be determined by the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR16).

The QIDS-SR 16 is a self-report questionnaire that assesses the severity of depressive symptoms. The 16 items (questions) on the QIDS-SR16 cover the nine diagnostic symptom criteria used in DSM.

Each item is rated 0-3. The QIDS-SR16 is scored by summing responses for each of the 16 items to obtain a total score ranging from 0 to 27.

A total score from 0 to 5 signifies absence of depression; 6 to 10 mild depression; 11 to 15 moderate depressions, 16 to 20 severe depression and from 21 to 27 very severe depression.

At 3 months following admission to the emergency service

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Clémence BIED, Dr, Hospices Civils de LYON

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de febrero de 2019

Finalización primaria (Actual)

9 de octubre de 2019

Finalización del estudio (Actual)

9 de octubre de 2019

Fechas de registro del estudio

Enviado por primera vez

30 de julio de 2018

Primero enviado que cumplió con los criterios de control de calidad

2 de agosto de 2018

Publicado por primera vez (Actual)

3 de agosto de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de octubre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

21 de octubre de 2019

Última verificación

1 de octubre de 2019

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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