- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07618754
Shame, Resilience and Well-being After Intimate Partner Violence: an Intervention Study With Replicated Single-Subject Design. (EMBER-4)
May 25, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tove Filén, PhD-student
- Phone Number: +46186170785
- Email: tove.filen@nck.uu.se
Study Locations
-
-
Uppsala County
-
Uppsala, Uppsala County, Sweden, 75185
- Uppsala University Hospital
-
Contact:
- Tove Filén
- Phone Number: +46186170785
- Email: tove.filen@nck.uu.se
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMBER intervention
|
A 4-step, Resilience-focused intervention based on the Resilience Portfolio Model, administered in individual format.
Other Names:
A 4-step, Resilience-focused intervention based on the Resilience Portfolio Model, administered in group format.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilience - Psychological Endurance
Time Frame: 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
Time Frame: 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
Time Frame: 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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health
Time Frame: 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
Time Frame: 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
Time Frame: 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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carolina Överlien, Professor, The National Centre for Knowledge on Men's Violence Against Women, Uppsala university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
June 1, 2030
Study Registration Dates
First Submitted
May 25, 2026
First Submitted That Met QC Criteria
May 25, 2026
First Posted (Actual)
June 1, 2026
Study Record Updates
Last Update Posted (Actual)
June 1, 2026
Last Update Submitted That Met QC Criteria
May 25, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMBER-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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