Uppsala University Hospital
Uppsala, Uppsala County, S-75185, Sweden
NCT Number: NCT07606586
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.
Trial opening soon.
Get Notified18 year and older
Female
Observational
Uppsala, Uppsala County, S-75185, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A Resilience-Focused Intervention based on the Resilience Portfolio Model.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Contact information is provided by the study sponsor or research team.
Uppsala University
Other
Acronym: EMBER-3
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