Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder
Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study investigates if prolonged exposure is an effective treatment in reducing PTSD symptoms people who have recently experienced trauma. The study will also investigate predictive markers of PTSD, moderators of successful treatment and health economic aspects of the intervention.
Participants will first undergo an evaluation session that will include an interview (Immediate Stress Reaction Checklist) and questionnaires. Participants will subsequently be randomly assigned to receive either modified prolonged exposure therapy or attention control, starting the assigned intervention immediately. Participants in each arm will receive three weekly treatment sessions. Treatment will involve psychoeducation about common reactions to trauma, imaginal exposure (revisiting memories of a recent trauma out loud with a therapist and audio-recording these for review at home), exposure in vivo and breathing retraining. All participants will undergo assessments 2, 6 (primary endpoint) and 12 months after the intervention by blinded assessors. Patients unable to come to the clinic for follow-up assessments will be interviewed via telephone or skype. Source data will be quality monitored by an independent party (Karolinska trial alliance) according to the Helsinki Declaration.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Stockholm, Suécia, 17177
- Karolinska Institutet
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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:
- Presenting to the emergency department at the Karolinska University hospital Solna in the past 72 hours before the intervention
- Meets diagnostic criterion A for post-traumatic stress disorder in the fifth version of Diagnostic and Statistical Manual of Mental Disorders, DSM-5
Exclusion Criteria:
- Do not want to participate in the study
- Ongoing intoxication (e.g. severe alcohol intoxication)
- Other serious psychiatric comorbidity that demands attention (e.g. manic episode, acute suicidal ideation)
- Not oriented
- Not having a memory ot the tramatic event
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 |
|---|---|
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Experimental: Modified prolonged exposure therapy
Participants will receive three sessions of modified prolonged exposure therapy.
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Participants will receive three sessions of modified prolonged exposure therapy.
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Comparador de Placebo: Attention control
Participants will receive three sessions of supportive counselling and psychoeducation
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Participants will receive three sessions of supportive counselling and psychoeducation
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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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CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
Prazo: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Prazo: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Self-report questionnaire for the assessment of PTSD severity
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Prazo: Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
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Self-report questionnaire for the assessment of severity of depression
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Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
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Euroqol (EQ-5D)
Prazo: Measured 6 months after intervention
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Measure of general health and quality of life
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Measured 6 months after intervention
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WHO Disability Assessment Schedule (WHODAS)
Prazo: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Measure of general health and function
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Adverse events
Prazo: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Measure of number adverse events
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Subjective unit of distress scale (SUD)
Prazo: Change at week 1, week 2 and week 3
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Ratings of distress
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Change at week 1, week 2 and week 3
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Intrusion diary
Prazo: Change at week 1, week 2 and week 3
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A self-report diary on number of intrusions
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Change at week 1, week 2 and week 3
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Insomnia Severity Index (ISI)
Prazo: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Self-report questionnaire regarding insomnia
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Multidimensional Scale of Perceived Social Support (MSPSS)
Prazo: Change 2-, 6- (primary endpoint) and 12 months after intervention
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A measure to assess for social support
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Trimbos Institute of costs in psychiatry (TIC-P)
Prazo: Measured at 6 (primary endpoint) months after the intervention
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Self-report measure on societal costs
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Measured at 6 (primary endpoint) months after the intervention
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Colaboradores e Investigadores
Patrocinador
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 (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EPN 2015/1820-31
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