Brief SEE FAR CBT Intervention Compared With Treatment as Usual for Adults With PTSD
13 de julio de 2026 actualizado por: Community Stress Prevention Center
A Clinical Study Evaluating the Effects of a Brief SEE FAR CBT Intervention Compared With Dynamic Psychotherapy Treatment as Usual on Psychological Outcomes in Adults With Posttraumatic Stress Disorder
This clinical intervention study evaluates a newly developed Brief SEE FAR CBT protocol for adults aged 18 years and older with posttraumatic stress disorder (PTSD), compared with dynamic psychotherapy treatment as usual.
Participants in the Brief SEE FAR CBT group will receive 6 focused sessions emphasizing intrusive PTSD symptoms and will then continue to complete the full 12-session SEE FAR CBT protocol.
Participants in the control group will receive dynamic psychotherapy as treatment as usual.
Psychological outcomes will be assessed using self-report questionnaires at four time points: baseline, after 6 sessions, after 12 sessions, and at a 3-month follow-up.
The study aims to examine changes in PTSD symptoms, anxiety, depression, perceived stress, resilience, somatic symptoms, sleep quality, and related psychological outcomes over the course of treatment and follow-up.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
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.
Estudio Contacto
- Nombre: Meital Mashash, PhD
- Número de teléfono: 972-50-2888052
- Correo electrónico: meitalm@icspc.org
Copia de seguridad de contactos de estudio
- Nombre: Sivan Raz, PhD
- Número de teléfono: 972-54-6634301
- Correo electrónico: sivanra@telhai.ac.il
Ubicaciones de estudio
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Sha'ar Hanegev, Israel
- Reclutamiento
- The Center for Psychological Services Sha'ar Hanegev
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Contacto:
- Tal Eilon
- Número de teléfono: 972-77-9802751
- Correo electrónico: tale@mpsy.org.il
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria
Participants must meet all of the following criteria:
- Age 18 years or older
- PTSD symptoms, defined as a PCL-5 score of 30-60
- Hebrew-speaking
- Able to provide informed consent
- Willing and able to participate in the assigned psychological intervention and complete study questionnaires at baseline, after 6 sessions, after 12 sessions, and at 3-month follow-up Exclusion Criteria
Participants will be excluded if they meet any of the following criteria:
- Pregnancy at the time of enrollment, due to the potential influence of pregnancy and childbirth during the treatment or follow-up period on psychological outcomes
- Currently receiving psychotherapy of any type that began less than 3 months prior to enrollment
- Initiation of psychiatric medication less than 3 months prior to enrollment
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: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Brief SEE FAR CBT Intervention
Participants in this arm will receive 6 focused sessions of Brief SEE FAR CBT, a newly developed protocol emphasizing intrusive PTSD symptoms.
After completing the 6 focused sessions, participants will continue to complete the full 12-session SEE FAR CBT protocol.
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Brief SEE FAR CBT is a focused trauma-oriented cognitive-behavioral intervention based on the SEE FAR CBT approach.
The brief protocol consists of 6 sessions delivered approximately once weekly, with emphasis on intrusive PTSD symptoms.
Participants will then continue treatment to complete the full 12-session SEE FAR CBT protocol.
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Experimental: Dynamic Psychotherapy Treatment as Usual
Participants in this arm will receive dynamic psychotherapy as treatment as usual, delivered approximately once weekly.
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Participants will receive dynamic psychotherapy as treatment as usual, delivered approximately once weekly.
This comparison condition represents the standard psychological treatment provided to participants in this clinical setting.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in PTSD symptoms
Periodo de tiempo: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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PTSD Checklist for DSM-5 (PCL-5) PTSD symptoms will be assessed using the PCL-5.
Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Change in PCL-5 total score will be examined from baseline to after 6 sessions, from baseline to after 12 sessions, from baseline to 3-month follow-up, from after 6 sessions to after 12 sessions, and from after 12 sessions to 3-month follow-up.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in anxiety symptoms
Periodo de tiempo: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Generalized Anxiety Disorder-7 (GAD-7) Anxiety symptoms will be assessed using the GAD-7.
Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Change in GAD-7 total score will be examined from baseline to after 6 sessions, from baseline to after 12 sessions, from baseline to 3-month follow-up, from after 6 sessions to after 12 sessions, and from after 12 sessions to 3-month follow-up.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in depressive symptoms
Periodo de tiempo: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Patient Health Questionnaire-9 (PHQ-9) Depressive symptoms will be assessed using the PHQ-9.
Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Change in PHQ-9 total score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in perceived stress
Periodo de tiempo: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Perceived Stress Scale (PSS) Perceived stress will be assessed using the PSS.
Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Change in PSS total score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in resilience
Periodo de tiempo: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Connor-Davidson Resilience Scale (CD-RISC) esilience will be assessed using the CD-RISC.
Total scores range from 0 to 40, with higher scores indicating greater resilience.
Change in CD-RISC total score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in somatic symptoms
Periodo de tiempo: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Patient Health Questionnaire-15 (PHQ-15) Somatic symptoms will be assessed using the PHQ-15.
Total scores range from 0 to 30, with higher scores indicating greater somatic symptom severity.
Change in PHQ-15 total score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in trauma-related use of imagination and coping
Periodo de tiempo: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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FRAME Trauma-related use of imagination and coping will be assessed using the FRAME questionnaire.
The FRAME is a 21-item measure of fantastic reality ability, defined as the capacity to use imagination in response to stress or trauma.
Items are rated on a 1-7 Likert scale, and mean scores range from 1 to 7, with higher scores indicating greater fantastic reality ability.
Change in FRAME score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in sleep quality
Periodo de tiempo: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Brief Version of the Pittsburgh Sleep Quality Index Sleep quality will be assessed using the brief version of the Pittsburgh Sleep Quality Index.
Change in sleep quality score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in PTSD-related functional impairment
Periodo de tiempo: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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PTSD-related functional impairment will be assessed using the functional impairment section of the Posttraumatic Diagnostic Scale (PDS).
This section includes 7 items assessing the extent to which PTSD-related problems interfered with work, relationships, leisure activities, family relationships, sex life, general life satisfaction, and overall functioning during the past two weeks.
Items are rated from 0 to 4, and total scores range from 0 to 28, with higher scores indicating greater functional impairment.
Change in functional impairment score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Meital Mashash, PhD, Community Stress Prevention Center
- Investigador principal: Sivan Raz, PhD, Tel Hai College
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 (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
1 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de julio de 2026
Publicado por primera vez (Actual)
17 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BRIEF-SEE-FAR-CBT-PTSD-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared due to the sensitive clinical nature of the data and participant privacy considerations.
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. .