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

2026年5月18日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

150

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • スウェーデン
    • Uppsala County
      • Uppsala、Uppsala County、スウェーデン、S-75185
        • Uppsala University Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
行動：Biopsychosocial Resilience Intervention for Women Subjected to IPV
A Resilience-Focused Intervention based on the Resilience Portfolio Model.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Well-Being
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Subjective General Health
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Uppsala University

捜査官

  • 主任研究者：Carolina Överlien, Professor、The National Centre for Knowledge on Men's Violence Against Women, Uppsala university

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月1日

一次修了 (推定)

2029年4月1日

研究の完了 (推定)

2029年4月1日

試験登録日

最初に提出

2026年4月29日

QC基準を満たした最初の提出物

2026年5月18日

最初の投稿 (実際)

2026年5月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月26日

QC基準を満たした最後の更新が送信されました

2026年5月18日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • EMBER-3

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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