Empowering Narratives

Официальное название

Styrkende Narrativ: Hjelp Til Selvhjelp for Ukrainske Flyktninger / Empowering Narratives: Help to Self-help to Ukrainian Refugees

Обзор

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.

Подробное описание

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).

REK also approved an emergency procedure for handling cases where participants score highly on depression or suicidal thoughts. The procedure includes a psychoeducative conversation with the participants by the project's PI (Vanessa Nolasco Ferreira) and the offer to send a letter to the participant's General Practitioner, with information about the depression and/or suicidal thoughts score. This letter will allow the GP to refer the participant to the specialized mental health services and reduce waiting times for treatment.

Sample Size Assessment:

A convenience sampling approach will be utilized, with the final sample size depending on the number of individuals who volunteer and meet the inclusion criteria. This approach accommodates variability in participant availability and willingness. The project has financial resources for NET training of 25 health workers, and each health worker needs to conduct supervised NET with two participants as part of the practical training that is necessary for NET certification. We are therefore aiming at 50 participants (25 in the intervention group and 25 in the waitlist control group). Previous NET interventions in similar populations have shown significant effects with comparable or considerably smaller sample sizes.

Plan for Missing Data:

The dropout rate during NET interventions tends to be low or zero, partially due to the short duration of interventions. Therefore, we expect minimal risk of missing datasets at post-treatment assessments. There might be a slightly higher risk for missing datasets at 6-months follow-up. We will compare demographic data and initial post-treatment effects of any dropouts with data of participants that complete the follow-up assessment, in order to evaluate potential biases due to systematic differences between dropouts and completers. There is no risk of missing data due to incomplete questionnaires (i.e. participants accidentally not answering single items) since the software used for assessment does not allow submission of the questionnaire unless all items are answered.

Вмешательства

• Поведенческое Narrative Exposure Therapy
  Narrative Exposure Therapy (NET) is a short-term, trauma-focused intervention developed for individuals exposed to multiple traumatic events, including refugees and survivors of war and organized violence. It is grounded in principles of cognitive-behavioral therapy and testimonial therapy. NET helps adults reconstruct a coherent narrative of their life by integrating fragmented traumatic memories through structured exposure within a chronological autobiographical framework. Core components incl

Первичные конечные точки

• PTSD Symptom Severity (ITQ) [Срок оценки: Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)]
• Dissociation Symptoms (Shut-D) [Срок оценки: Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)]
• Depression Symptoms (PHQ-9) [Срок оценки: Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)]

Вторичные конечные точки (1)

• Exposure to Traumatic Events (LEC-5) [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Ukrainian refugee residing in Norway.
• Arrival in Norway after 24 February 2022.
• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Норвегия · 1 центр

• Kristinia University of Applied Sciences — Oslo

Публикации

• Schauer M, Neuner F, Elbert T. Narrative Exposure Therapy (NET) For Survivors of Traumatic Stress. 3 ed: Hogrefe Publishing; 2025
• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. PMID 11556941
• Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3. PMID 30178492
• Gray MJ, Litz BT, Hsu JL, Lombardo TW. Psychometric properties of the life events checklist. Assessment. 2004 Dec;11(4):330-41. doi: 10.1177/1073191104269954. PMID 15486169
• Schalinski I, Schauer M, Elbert T. The shutdown dissociation scale (shut-d). Eur J Psychotraumatol. 2015 May 13;6:25652. doi: 10.3402/ejpt.v6.25652. eCollection 2015. PMID 25976478
• Labberton AS, Ozeryansky L, Helland Y, Skogheim TS, Hansen TM. Trends in the health status of Ukrainian refugees in Norway according to month of arrival during 2022. BMC Public Health. 2024 Nov 12;24(1):3127. doi: 10.1186/s12889-024-20660-0. PMID 39533254
• Labberton AS, Hansen TM, Skogheim TS, Helland Y. Healthcare needs among refugees from Ukraine arriving in Norway during 2022. Norwegian Institute of Public Health; 2023 May 2023.
• Ardino V, Schalinski I. Recent developments of narrative exposure therapy. Maltrattamento e Abuso All'Infanzia: Rivista Interdisciplinare. 2020;.22(3):pp

Идентификаторы

NCT: NCT07062042 · Styrkende Narrativ Kristiania · 547119

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗