- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07618754
Shame, Resilience and Well-being After Intimate Partner Violence: an Intervention Study With Replicated Single-Subject Design. (EMBER-4)
25 de mayo de 2026 actualizado por: Uppsala University
The EMBER protocol is a health care method that is designed to increase resilience, in order to improve well-being and overall health in women who have experienced violence by a partner.
This study explores whether the EMBER intervention works in this way.
Eight participants will take part in the EMBER program and complete questionnaires every week during the intervention.
The researchers will compare the timeline for the intervention to how resilience levels change.
They will also check whether changes in resilience are linked to changes in health and well-being.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Intimate partner violence (IPV) is a global problem with complex consequences in society as well as for the victim/survivor.
The EMBER-protocol was developed at National Center for Knowledge on Men´s violence against Women, Uppsala University, Sweden.
The purpose of the protocol is to provide women who have been subjected to IPV with support and tools for empowerment and improving resilience, thereby improving health and well-being.
In this study with replicated single-case design, 8 patients will complete questionnaires bi-weekly while taking part of the intervention, starting from their very first contact with the clinic.
The questionnaires are completed using a mobile application.
Data will be processed using a combination of visual and statistical analysis, in order to examine how interventions intended to improve resilience, changes in resilience measures and changes in well-being and health relate to each other temporally.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
8
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: Tove Filén, PhD-student
- Número de teléfono: +46186170785
- Correo electrónico: tove.filen@nck.uu.se
Ubicaciones de estudio
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Uppsala County
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Uppsala, Uppsala County, Suecia, 75185
- Uppsala University Hospital
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Contacto:
- Tove Filén
- Número de teléfono: +46186170785
- Correo electrónico: tove.filen@nck.uu.se
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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:
- subjected to IPV within 2 years prior to enrollment
- capable of completing questionnaires using a mobile phone
- intention to complete intervention
- identifies as female
Exclusion Criteria:
- ongoing severe IPV
- ongoing severe substance use
- psychosis
- moderate to severe suicidality
- ongoing psychological intervention in other facility
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: EMBER intervention
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A 4-step, Resilience-focused intervention based on the Resilience Portfolio Model, administered in individual format.
Otros nombres:
A 4-step, Resilience-focused intervention based on the Resilience Portfolio Model, administered in group format.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Resilience - Psychological Endurance
Periodo de tiempo: Bi-weekly from enrollment 2-6 weeks prior to start of intervention, to completion of the intervention (intervention phase A and/or C). Follow-up 6 weeks post-intervention.
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The self assessment questionnaire Psychological Endurance Scale (range 6-24, higher value indicates higher endurance) is completed bi-weekly using a mobile application.
Data will be analyzed with a combination of visual and statistical analyses.
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Bi-weekly from enrollment 2-6 weeks prior to start of intervention, to completion of the intervention (intervention phase A and/or C). Follow-up 6 weeks post-intervention.
|
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Resilience - Subjective Social Support
Periodo de tiempo: Bi-weekly from enrollment 2-6 weeks prior to start of intervention to completion of the intervention (intervention phase A and/or C). Follow-up 6 weeks post-intervention.
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The Oslo Subjective Social Support Scale - 3 items (range 3-14, higher value indicates higher level of social support) is completed bi-weekly using a mobile application.
Data will be processed using a combination of visual and statistical analyses.
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Bi-weekly from enrollment 2-6 weeks prior to start of intervention to completion of the intervention (intervention phase A and/or C). Follow-up 6 weeks post-intervention.
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Resilience - Meaning Making
Periodo de tiempo: Bi-weekly from enrollment 2-6 weeks prior to start of the intervention, to completion of the intervention (intervention phase A and/or C). Follow-up 6 weeks post-intervention.
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The MAPS - Meaningfulness subscale (range 5-25, higher value indicating higher meaningfulness) is completed by the subjects bi-weekly.
Data is processed using a combination of statistical and visual analyses.
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Bi-weekly from enrollment 2-6 weeks prior to start of the intervention, to completion of the intervention (intervention phase A and/or C). Follow-up 6 weeks post-intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Health
Periodo de tiempo: Bi-weekly from enrollment 2-6 weeks prior to the intervention, to completion of the intervention (intervention phase A and/or C). Follow-up 6 weeks post-intervention.
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General, Somatic, Mental, Social and Sexual health is measured by 5 questions regarding subjective health the past week which are administered to the subject using a mobile application.
The subject grades ones health on a visuoanalogue scale ranging from -10 to +10.
The range on the total scale is thus -50 to +50, subscales -10 to +10.
Higher value indicates better health.
Data is processed using a combination in visual and statistical analyses.
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Bi-weekly from enrollment 2-6 weeks prior to the intervention, to completion of the intervention (intervention phase A and/or C). Follow-up 6 weeks post-intervention.
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Shame
Periodo de tiempo: Bi-weekly from enrollment 2-6 weeks prior to start of the intervention, to completion of the intervention (intervention phase A and/or C). Follow-up 6 at weeks post-intervention.
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Shame is measured using the External and Internal Shame Scale (EISS; range 0.00-4.00,
higher value indicating higher levels of shame), administered to patients using a mobile application.
Data is processed using a combination of statistical and visual analyses.
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Bi-weekly from enrollment 2-6 weeks prior to start of the intervention, to completion of the intervention (intervention phase A and/or C). Follow-up 6 at weeks post-intervention.
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Well-Being
Periodo de tiempo: Bi-weekly from enrollment 2-6 weeks prior to start of the intervention, to completion of the intervention (intervention phase A and/or C). Follow-up at 6 weeks post-intervention.
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Well-being is measured bi-weekly using the Questionnaire on Well-Being (QWB, range 0-72, higher value indicating more wellbeing).
Data is processed using a combination of statistical and visual analyses.
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Bi-weekly from enrollment 2-6 weeks prior to start of the intervention, to completion of the intervention (intervention phase A and/or C). Follow-up at 6 weeks post-intervention.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Carolina Överlien, Professor, The National Centre for Knowledge on Men's Violence Against Women, Uppsala university
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 junio de 2026
Finalización primaria (Estimado)
1 de mayo de 2030
Finalización del estudio (Estimado)
1 de junio de 2030
Fechas de registro del estudio
Enviado por primera vez
25 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EMBER-4
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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