- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07618754
Shame, Resilience and Well-being After Intimate Partner Violence: an Intervention Study With Replicated Single-Subject Design. (EMBER-4)
25. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
8
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Tove Filén, PhD-student
- Telefonnummer: +46186170785
- E-post: tove.filen@nck.uu.se
Studiesteder
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Uppsala County
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Uppsala, Uppsala County, Sverige, 75185
- Uppsala University Hospital
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Ta kontakt med:
- Tove Filén
- Telefonnummer: +46186170785
- E-post: tove.filen@nck.uu.se
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: EMBER intervention
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A 4-step, Resilience-focused intervention based on the Resilience Portfolio Model, administered in individual format.
Andre navn:
A 4-step, Resilience-focused intervention based on the Resilience Portfolio Model, administered in group format.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Resilience - Psychological Endurance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Health
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Carolina Överlien, Professor, The National Centre for Knowledge on Men's Violence Against Women, Uppsala university
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. mai 2030
Studiet fullført (Antatt)
1. juni 2030
Datoer for studieregistrering
Først innsendt
25. mai 2026
Først innsendt som oppfylte QC-kriteriene
25. mai 2026
Først lagt ut (Faktiske)
1. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EMBER-4
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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