- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07618754
Shame, Resilience and Well-being After Intimate Partner Violence: an Intervention Study With Replicated Single-Subject Design. (EMBER-4)
25. maj 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
8
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Tove Filén, PhD-student
- Telefonnummer: +46186170785
- E-mail: tove.filen@nck.uu.se
Studiesteder
-
-
Uppsala County
-
Uppsala, Uppsala County, Sverige, 75185
- Uppsala University Hospital
-
Kontakt:
- Tove Filén
- Telefonnummer: +46186170785
- E-mail: tove.filen@nck.uu.se
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: EMBER intervention
|
A 4-step, Resilience-focused intervention based on the Resilience Portfolio Model, administered in individual format.
Andre navne:
A 4-step, Resilience-focused intervention based on the Resilience Portfolio Model, administered in group format.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
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.
|
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.
|
|
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.
|
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.
|
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.
|
|
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.
|
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.
|
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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
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.
|
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.
|
|
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.
|
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.
|
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.
|
|
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.
|
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.
|
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Carolina Överlien, Professor, The National Centre for Knowledge on Men's Violence Against Women, Uppsala university
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. maj 2030
Studieafslutning (Anslået)
1. juni 2030
Datoer for studieregistrering
Først indsendt
25. maj 2026
Først indsendt, der opfyldte QC-kriterier
25. maj 2026
Først opslået (Faktiske)
1. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EMBER-4
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .