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- Ensaio Clínico NCT01911585
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19106
- Center for the Treatment and Study of Anxiety
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Primary diagnosis of PTSD
- Recommended by therapist to receive Prolonged Exposure therapy
Exclusion Criteria:
- Current substance dependence, psychosis, suicidal ideation with intent and plan, or other psychiatric problems warranting immediate clinical attention or would interfere with Prolonged Exposure therapy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 90 minute Prolonged Exposure Sessions
Prolonged Exposure Therapy for PTSD consists of 10 to 15 weekly or twice-weekly sessions, each lasting about 90 minutes, with 40 to 60 minutes imaginal exposure.
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Prolonged exposure therapy (PE), a specific exposure therapy program for PTSD is a highly effective treatment for PTSD.
The key components of PE are imaginal exposure to the traumatic event and processing it (revisiting of the traumatic memory in imagination) followed by processing of the revisiting experience, and in vivo exposure to avoided trauma-related situations and objects.
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Experimental: 60 minute Prolonged Exposure Sessions
This treatment condition is a modified version of Prolonged Exposure therapy for PTSD.
It consists of 10 to 15 weekly or twice-weekly sessions, each lasting about 60 minutes, with 20 minutes imaginal exposure.
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Prolonged exposure therapy (PE), a specific exposure therapy program for PTSD is a highly effective treatment for PTSD.
The key components of PE are imaginal exposure to the traumatic event and processing it (revisiting of the traumatic memory in imagination) followed by processing of the revisiting experience, and in vivo exposure to avoided trauma-related situations and objects.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in PTSD Symptom Scale, Interview Version (PSS-I; Foa, Riggs, Dancu, & Rothbaum, 1993; Powers, Gillihan, Rosenfield, Jerud & Foa, 2012)
Prazo: Pre-treatment through 6 month follow-up
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The PSS-I will be administered on 4 separate occasions We will measure the change in PSS-I scores from pre-treatment to post-treatment, 3 month follow-up, and 6 month follow-up. The PSS-I is a 20-minute, 17-item clinical interview that evaluates DSM-IV PTSD symptoms on a frequency/severity scale. The interview yields a full-scale score and subscales for each of the three PTSD symptom clusters. Psychometric studies revealed internal reliability of .91 for the full scale, and .78, .80, and .82 for the reexperiencing, avoidance and arousal clusters (Foa & Tolin, 2000). |
Pre-treatment through 6 month follow-up
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Posttraumatic Diagnostic Scale (PDS; Foa et al., 1997)
Prazo: Pre-treatment through 6 months post-treatment
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The PDS will be administered at every other treatment session and at post-treatment, 3 month follow-up, and 6 month follow-up. The measure will be used to closely monitor treatment progress and help assess severity of symptoms. The PDS is a 17-item self-report measure that provides total and subscale severity scores and categorical classification of PTSD. The PDS demonstrated high internal consistency (.92 total, .78 re-experiencing, .84 avoidance, and .84 hyperarousal). Test-retest reliability is good, ranging from .74 to .85. High diagnostic agreement (82%) with the SCID-IV was noted: sensitivity was .89, and specificity, .75. The PDS is highly related to other measures of trauma related psychopathology. Participants will complete this measure at the beginning of every other treatment session. |
Pre-treatment through 6 months post-treatment
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Beck Depression Inventory (BDI; Beck et al., 1961)
Prazo: Pre-treatment through 6 month follow-up
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The BDI will be administered at every other treatment session and at post-treatment, 3 month follow-up, and 6 month follow-up. The measure will be used to closely monitor treatment progress and help assess severity of symptoms. The BDI is a 21-item scale assessing depression. The inventory's internal consistency ranges from .58 to .93, test-retest reliability ranges from .69 to .90. Participants will complete this report measure at the beginning every other treatment session. |
Pre-treatment through 6 month follow-up
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Post-Traumatic Cognitions Inventory (PTCI; Foa et al., 1999)
Prazo: Pre-treatment through 6 month follow-up
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The PTCI will be administered at every other treatment session and at post-treatment, 3 month follow-up, and 6 month follow-up. The measure will be used to closely monitor treatment progress and help assess severity of symptoms. This 36-item instrument assesses post-trauma cognitions across self, world, and self-blame and yields a total score. The scale has high internal consistency (.97, .88, .86, 97, respectively) and correlates well with PTSD severity, anxiety, and depression (.44 to .79). This 36-item instrument assesses dysfunctional post trauma cognitions theoretically thought to underlie the development of PTSD. Participants will complete this measure at the beginning of every treatment session. |
Pre-treatment through 6 month follow-up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Edna B. Foa, Ph.D., University of Pennsylvania
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
- 817717
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