- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07606586
Resilience and Recovery After Intimate Partner Violence - Evaluation of the EMBER-IPV Protocol (EMBER-3)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Tove Filén, PhD-student
- Telefonnummer: +46186170785
- E-post: tove.filen@nck.uu.se
Studieorter
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Uppsala County
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Uppsala, Uppsala County, Sverige, S-75185
- Uppsala University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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.
|
A Resilience-Focused Intervention based on the Resilience Portfolio Model.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Well-Being
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Subjective General Health
Tidsram: 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.
|
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Psychological Endurance
Tidsram: 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
Tidsram: 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.
|
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Depression
Tidsram: 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.
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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.
|
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Subjective Psychosocial Health
Tidsram: 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
Tidsram: 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.
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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
Tidsram: 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
Tidsram: 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.
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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.
|
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Subjective Social Support
Tidsram: 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.
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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.
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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.
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Meaningfulness
Tidsram: 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.
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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.
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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.
|
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Posttraumatic stress symptoms
Tidsram: 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.
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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.
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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.
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Subjective Stress
Tidsram: 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.
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Subjective Stress is measured by the Single Item Stress Questionnaire (SISQ; range 1-5, higher value indicating more stress)
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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.
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Carolina Överlien, Professor, The National Centre for Knowledge on Men's Violence Against Women, Uppsala university
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- EMBER-3
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