- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03116165
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Stockholm, Suecia, 17177
- Karolinska Institutet
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
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 placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Measure of general health and function
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Adverse events
Periodo de tiempo: Change 2-, 6- (primary endpoint) and 12 months after intervention
|
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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EPN 2015/1820-31
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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