Styrkende Narrativ: Hjelp Til Selvhjelp for Ukrainske Flyktninger / Empowering Narratives: Help to Self-help to Ukrainian Refugees
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- PTSD Symptom Severity (ITQ)
研究概览
简要总结
Background: The Russian invasion of Ukraine has resulted in forced displacement, with over 80,000 Ukrainian refugees now residing in Norway. This displacement has led to increased vulnerability to trauma and mental health challenges. Narrative Exposure Therapy (NET), a short-term trauma-focused intervention, has demonstrated efficacy in reducing PTSD symptoms among individuals exposed to organized violence and war.
Aim: The protocol aims to assess the clinical effects of Narrative Exposure Therapy (NET) on PTSD and depression symptoms among Ukrainian refugees in Norway and to facilitate training and supervised practice for Ukrainian health professionals and workers in using NET.
Methods: This study employs a pretest-posttest randomized controlled experimental design. Ukrainian health professionals and workers in Norway will receive standardized NET training through a digital course. Subsequently, they will treat Ukrainian refugees using NET under supervision. Participants will be screened and assessed at three time points: baseline, immediately after treatment, and at 6-month follow-up. Validated questionnaires in Ukrainian and Russian will be used: PHQ-9, ITQ, LEC-5, SHUT-D, and demographic questionnaire. Exclusion criteria include active psychotic spectrum disorders, neurodevelopmental disorders and concurrent trauma therapy.
详细描述
Ethical Approval:
The study received ethical approval from the Regional Committees for Medical and Health Research Ethics - South-East D (REK sør-øst D) in Norway, under reference number 790305.
Quality Assurance and Data Management:
The proposed study will not use any registry data and instead collect data with validated questionnaires. Questionnaires will be filled in during interviews with the NET therapist, which will increase data quality by ensuring that participants understand the questions and are engaged in answering them. The questionnaires were translated to Ukrainian by the Trauma Consortium, which helps to ensure both quality and understanding from both patients and health workers. Questionnaire data will be coded in accordance with the published manuals for the respective questionnaires, and a data dictionary will be used to describe each variable according to the manuals.
All data, including notes from NET sessions and the resulting narratives, will be stored on a secure server, TSD (link to the website can be found in the reference list). Questionnaire data will be collected with a secure and anonymous data collection tool, Nettskjema (link to the website can be found in the reference list), and will be directly transferred to TSD. The study will also include a link key, stored in TSD, that links the participant's name to an anonymous code, and the anonymous code to the dataset, so that data will not be stored together with the participants' names. The data management in the current study has been assessed with a Data Protection Impact Assessment (DPIA) and has been approved by the Norwegian Agency for Shared Services in Education and Research, SIKT (link to the website in the reference list) and the Norwegian Regional Committee for Medical and Health Research Ethics, REK (link to the website can be found in the reference list).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ukrainian refugee residing in Norway.
- •Arrival in Norway after 24 February
- •Minimum 18 years old
- •Provided informed consent for participation.
- •Classified as having PTSD symptoms (ITQ) OR reported traumatic experience (LEC-5) OR present PTSD comorbidities (PHQ-9, Shut-D).
排除标准
- •Diagnosis, history, or scores compatible with the psychotic spectrum
- •Diagnostic of neurodevelopmental disorders
- •Current participation in ongoing trauma-focused psychological treatment (e.g., therapy for PTSD).
- •Declining consent for mandatory elements of the study (e.g., participation in screening or treatment delivery).
结局指标
主要结局
PTSD Symptom Severity (ITQ)
时间窗: Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)
Assesses symptoms of PTSD and Complex PTSD, including re-experiencing, avoidance, threat perception, and functional impairment. Instrument: International Trauma Questionnaire (ITQ) Outcome Focus: Change in PTSD symptom scores over time (H1, H4)
Dissociation Symptoms (Shut-D)
时间窗: Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)
Measures dissociative responses specific to trauma, including cognitive-emotional shutdown, sensory-motor dissociation, and behavioral shutdown. Instrument: Shutdown Dissociation Scale (Shut-D) Outcome Focus: Change in dissociation symptom scores over time (H2, H5)
Depression Symptoms (PHQ-9)
时间窗: Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)
Measures the frequency of depressive symptoms over the past two weeks, including somatic and cognitive-affective dimensions, plus functional impairment. Instrument: Patient Health Questionnaire-9 (PHQ-9) Outcome Focus: Change in depressive symptoms (H3, H6)
次要结局
- Exposure to Traumatic Events (LEC-5)(Baseline)