Optimal Dose of Early Intervention to Prevent PTSD
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The precipitant for adult posttraumatic stress disorder (PTSD) is a known event, which allows for immediate intervention and presents the potential to prevent the occurrence of this serious condition. However, there currently are no accepted interventions for the early intervention and prevention of PTSD in the immediate aftermath of trauma. This study will determine whether providing exposure therapy to people who have recently experienced trauma will significantly reduce the severity of PTSD symptoms post-trauma and if delivery of three exposure sessions will result in larger reductions in the symptoms of PTSD post-trauma than one exposure session. This study will also examine predictors for treatment response.
Participation in this study will last 12 months. Participants will first undergo an evaluation session that will include an interview and questionnaires. They will then be randomly assigned to one of the following three conditions: 1-session exposure therapy, 3-session exposure therapy, or assessment only. Participants receiving 1-session exposure therapy will complete one treatment session in the emergency department (ED). Participants receiving 3-session exposure therapy will complete three weekly treatment sessions, with the first occurring in the ED. Treatment will involve reviewing memories of a recent trauma out loud with a therapist and audio-recording these discussions for review at home. All participants will undergo assessments 1, 3, 6, and 12 months after the initial evaluation session.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30303
- Grady Memorial Hospital, Emergency Department
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Presenting to the emergency department of Emory University School of Medicine/Grady Memorial Hospital for trauma in the past 72 hours
- Meets DSM-IV diagnostic criterion A in which both of the following are present: (i) The person experienced, witnessed, or was confronted with an event or events that involved actual or threatened death or serious injury or a threat to the physical integrity of self or others (ii) The person's response involved intense fear, helplessness, or horror
- Speaks and understands spoken English
- Have a memory of what happened during the trauma
- Can see the assessment forms, hear instructions, and function at an emotional and intellectual level sufficient to allow accurate completion of all assessment instruments
Exclusion Criteria:
- Current or history of mania, schizophrenia, or other psychoses
- Current (past month) prominent suicidal ideation or recent (past 3 months) parasuicidal behavior or other self-injurious behavior, such as low lethality cutting
- Current (past month) substance dependence; people who meet criteria for current substance abuse but not dependence, or past dependence and have been in remission for at least 1 month are eligible
- Experienced a loss of consciousness for more than 5 minutes as a result of injuries sustained during the trauma
- Intoxicated, altered, or highly distressed to the degree that accurate completion of the study assessments or participation in study procedures is not possible
- Blood alcohol level above .08, determined by breathalyzer in the emergency department
- Not alert, oriented, and coherent
- In severe pain, active labor, or respiratory distress or hemodynamically compromised in any way
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Assessment only
Participants will receive assessment only.
|
|
|
Experimental: 1-session exposure intervention
Participants will receive one session of exposure therapy.
|
One exposure therapy session lasting one hour
|
|
Experimental: 3-session exposure intervention
Participants will receive three sessions of exposure therapy.
|
Three exposure therapy sessions lasting one hour each, delivered one week apart
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Change in PTSD Symptom Scale-I (PSS)
Prazo: Measured 1, 3, 6, 12 months post-trauma
|
Measured 1, 3, 6, 12 months post-trauma
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Barbara O. Rothbaum, PhD, Emory University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB00063758
- NARSAD 19798 (Outro identificador: Other)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em 1-Session Exposure Therapy
-
Azienda Ospedaliera Universitaria Integrata VeronaConcluído
-
AllerganConcluídoSíndrome do Olho SecoEstados Unidos
-
AllerganConcluídoSíndrome do Olho SecoEstados Unidos