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Resilience and Recovery After Intimate Partner Violence - Evaluation of the EMBER-IPV Protocol (EMBER-3)

18 maggio 2026 aggiornato da: Uppsala University
The EMBER-protocol is an intervention used at the NCK clinic at Uppsala University Hospital with the purpose of helping women utilize their resilience and strengths in order to recover after intimate partner violence. This study is conducted in order to explore how health and resilience changes during the course of the EMBER-intervention. The participants are asked to complete questionnaires before, during and after the intervention.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Intimate partner violence (IPV) is a complex problem with extensive consequences for the individual as well as on a societal scale. In Sweden, there is a lack of accessible, cohesive, evidence-based models for biopsychosocial healthcare of survivors of IPV. A resilience-based intervention, the EMBER-protocol, has been developed at National Center for Knowledge on Men's Violence against Women (NCK) in Uppsala, Sweden. Based on cognitive behavior therapy and resilience research, the EMBER-protocol targets factors that have been found relevant for posttraumatic recovery and reorientation after IPV. The aim is to increase well-being and recovery, i.e. increase healthy functioning and reduce mental health symptoms in women who have been subjected to IPV. The protocol is conceptually divided into a stabilizing (A), a processing (B) and a reorienting (C) phase. This study is part of the EMBER-IPV-project, which purpose is to evaluate the effectiveness of the EMBER-protocol, focusing on phases A and C, which are carried out by midwives and nurses. The research question in EMBER-3 is:

How do the subjects´ self-assessed levels of the following variables change during the course of the intervention: Well-being, Resilience, Health (general, somatic, mental, sexual and social), Stress and Shame? Data will be collected by self-assessment questionnaires at start and completion of phase A, at start, after completion of 0, 2 and 4 group sessions in phase B, as well as 6 weeks and 6 months post-group-intervention in phase C. Data will be analyzed with t-test and mixed effects models.

Tipo di studio

Osservativo

Iscrizione (Stimato)

150

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Svezia
    • Uppsala County
      • Uppsala, Uppsala County, Svezia, S-75185
        • Uppsala University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

All patients at the NCK Outpatient Clinic for Women Subjected to Intimate Partner Violence or Sexual Abuse, Uppsala University Hospital who meet the eligibility criteria during the enrollment period will be asked to participate in the study.

Descrizione

Inclusion Criteria:

  • Women taking part of the EMBER intervention (phase A or C)
  • Subjected to IPV within the past 2 years prior to enrollment

Exclusion Criteria:

  • Ongoing severe intimate partner violence
  • Ongoing severe substance abuse
  • Severe mental health problems such as psychosis, suicidality

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Women Subjected to Intimate Partner Violence
Women who are enrolled at the NCK Outpatient Clinic at Uppsala University Hospital due to having been subjected to Intimate Partner Violence and Abuse within the past 2 years, taking part of the standard intervention at the clinic. The target is to have 100 participants in two different phases of the intervention (phase A and C). Due to the fact that not all patients who take part of phase A will continue to phase C, additional participants will be recruited in order to reach the goal of n=100 in each of the two phases.
Comportamentale: Biopsychosocial Resilience Intervention for Women Subjected to IPV
A Resilience-Focused Intervention based on the Resilience Portfolio Model.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Well-Being
Lasso di tempo: Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Participants complete the self assessment questionnaire Questionnaire of Wellbeing (scale 0-72 points, higher value indicates higher level of wellbeing) in connection to a visit at the NCK Outpatient Clinic. Change from pre to post is analyzed using t-test and mixed effects models.
Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Subjective General Health
Lasso di tempo: Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Participants are asked to rate their general health on a thermometer-like scale with the same procedure as in EuroQuol5Dimensions (EQ5D; 0-100, higher value indicates better health). Change from pre to post is analyzed using t-test and mixed effect models.
Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Psychological Endurance
Lasso di tempo: Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
The self assessment questionnaire Psychological Endurance Scale (range 6-24, higher value indicates higher endurance) is administered to the participants in connection to their visit at the NCK Outpatient Clinic. Change from pre to post is analyzed with t-tests and mixed effect models.
Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Shame
Lasso di tempo: Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Participants complete the self assessment questionnaire External and Internal Shame Scale (EISS; range 0.00-4.00, higher value indicates higher level of shame) in connection to a visit at the NCK Outpatient Clinic. Change from pre to post is analyzed using t-test and mixed effects models.
Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Depression
Lasso di tempo: Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Participants complete the Patient Health Questionnaire-9 (PHQ-9; range 0-27, higher values indicate higher levels of depression) in connection to a visit at the NCK Outpatient Clinic. Change from pre to post is analyzed using t-test and mixed effects models.
Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Subjective Psychosocial Health
Lasso di tempo: Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Participants are asked to rate their subjective psychosocial health on a visuoanalogue scale 100mm, in a composite measure with three items regarding how content the person has been with their mental, sexual and social health the past week. The Subjective Psychosocial Health measure has a range of 0-300 and three subscales of 0-100 each, higher value indicating better psychosocial health. Change from pre to post is analyzed using t-test and mixed effects models.
Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
General Somatic Pain
Lasso di tempo: Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Pain during past week is rated on a visuo-analogue scale 0-100mm . Higher value indicates higher pain. Change from pre to post is analyzed using t-test and mixed effects models.
Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Subjective General Health
Lasso di tempo: Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Participants are asked to rate their general health on a thermometer-like scale with the same procedure as in EuroQuol5Dimensions (EQ5D; range 0-100, higher value indicates better health). Change from pre to post is analyzed using t-test and mixed effect models.
Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Social Support Seeking
Lasso di tempo: Data collection phase A: at 0 weeks and at completion(approximately 12-20 weeks); phase C: 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow up: 6 weeks and 6 months post-group-intervention.
The Social Support Seeking scale (range 6-24, higher value indicates higher level of social support seeking) is administered to patients in connection to their visit at the clinic. Change from pre to post is analyzed using t-test and mixed effects models.
Data collection phase A: at 0 weeks and at completion(approximately 12-20 weeks); phase C: 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow up: 6 weeks and 6 months post-group-intervention.
Subjective Social Support
Lasso di tempo: Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
The subject´s perception of social support available is measured by administering the Oslo Social Support Scale - 3 items (OSSS-3; range 3-14, higher value indicates higher level of perceived support) in connection to their visit at the clinic. Change from pre to post is analyzed using t-test and mixed effects models.
Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Meaningfulness
Lasso di tempo: Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
The subjects´ sense of meaningfulness is measured with the Meaningfulness Scale (range 0-20, higher value indicating higher levels of meaningfulness) in connection to their visit at the clinic. Change from pre to post is analyzed using t-test and mixed effects models.
Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Posttraumatic stress symptoms
Lasso di tempo: Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Participants complete the National Stressful Events Survey PTSD Short Scale (NSESSS; range 0-36, higher values indicate higher levels of posttraumatic stress symptoms) in connection to a visit at the NCK Outpatient Clinic. Change from pre to post is analyzed using t-test and mixed effects models.
Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Subjective Stress
Lasso di tempo: Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.
Subjective Stress is measured by the Single Item Stress Questionnaire (SISQ; range 1-5, higher value indicating more stress)
Data collection intervention A at 0 weeks and at completion (approximately 12-20 weeks); intervention C at 2 weeks pre-group and at start, middle and end of group intervention (0, 2 and 4 weeks); follow-up 6 weeks and 6 months post-group-intervention.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Uppsala University

Investigatori

  • Investigatore principale: Carolina Överlien, Professor, The National Centre for Knowledge on Men's Violence Against Women, Uppsala university

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 aprile 2029

Completamento dello studio (Stimato)

1 aprile 2029

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • EMBER-3

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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