Study Results
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Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-03-01
2026-04-20
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Quantitative data will be collected from both groups using a repeated screening measures approach. For the intervention group, data will be gathered at three timepoints: (1) baseline (prior to treatment), (2) post-treatment (approximately one week after the final session), and (3) follow-up (six months after treatment completion). For the control group, data will be collected at two timepoints: (1) baseline, and (2) after a waiting period equivalent in length to the intervention group's treatment phase, prior to their own treatment onset.
TREATMENT
NONE
Study Groups
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Case
Participants assigned to that arm receive Narrative Exposure Therapy (intervention) immediately after the baseline screening
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 include lifeline construction, imaginal exposure to traumatic events, and reprocessing of emotional responses. The method emphasizes stabilization through therapeutic structure and is supported by evidence from randomized controlled trials showing reductions in PTSD symptoms. The approach is protocol-driven and applicable in low-resource settings under supervision, as outlined in the practice document.
Control
Waiting List: the participant waits and receives no intervention until the treatment and the re-screening of the case participant is done. Then the control participant, assigned to the waiting list, receive the same intervention.
No interventions assigned to this group
Interventions
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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 include lifeline construction, imaginal exposure to traumatic events, and reprocessing of emotional responses. The method emphasizes stabilization through therapeutic structure and is supported by evidence from randomized controlled trials showing reductions in PTSD symptoms. The approach is protocol-driven and applicable in low-resource settings under supervision, as outlined in the practice document.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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University of Konstanz
OTHER
Oswaldo Cruz Foundation
OTHER
Mental helse
UNKNOWN
Vårsta Diakoni
UNKNOWN
Norsk-Ukrainsk hjelpeorganisasjon
UNKNOWN
The Dam Foundation
OTHER
Kristiania University College
OTHER
Responsible Party
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Principal Investigators
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Vanessa Nolasco Ferreira, Associate Professor, PhD
Role: PRINCIPAL_INVESTIGATOR
Kristiania University of Applied Sciences
Locations
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Kristinia University of Applied Sciences
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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
Tracy SJ. A phronetic iterative approach to data analysis in qualitative research. 질적연구. 2018;19(2):61-76
Lely JCG, Smid GE, Jongedijk RA, W Knipscheer J, Kleber RJ. The effectiveness of narrative exposure therapy: a review, meta-analysis and meta-regression analysis. Eur J Psychotraumatol. 2019 Mar 25;10(1):1550344. doi: 10.1080/20008198.2018.1550344. eCollection 2019.
Wei Y, Chen S. Narrative exposure therapy for posttraumatic stress disorder: A meta-analysis of randomized controlled trials. Psychol Trauma. 2021 Nov;13(8):877-884. doi: 10.1037/tra0000922. Epub 2021 Feb 22.
Ferreira VN, Hjelmervik H, Bell-Mizori AR, Tokovska M, Domogalla SA, Serpeloni F, Axelson S, Arango I, Weber S. Empowering narratives: aid to self-help for Ukrainian refugees: a randomized controlled trial of Narrative Exposure Therapy (NET) delivered by supervised Ukrainian health workers in Norway. Eur J Psychotraumatol. 2025 Dec;16(1):2567094. doi: 10.1080/20008066.2025.2567094. Epub 2025 Oct 27.
Provided Documents
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Document Type: Study Protocol: Ethical Committee
Document Type: Study Protocol and Statistical Analysis Plan: Methods and Analysis
Document Type: Informed Consent Form
Related Links
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UNHCR. The Operational Data Portal 2025
TSD, Tjenester for Sensitive Data - secure data storage server
Nettskjema - secure questionnaire data collection tool
SIKT - Norwegian Agency for Shared Services in Education and Research
REK - Norwegian Regional Committee for Medical and Health Research Ethics
Other Identifiers
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547119
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Styrkende Narrativ Kristiania
Identifier Type: -
Identifier Source: org_study_id
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