Empowering Narratives

NCT07062042 | Recruiting DMC

• 2 other identifiers: Styrkende Narrativ Kristiania547119
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PTSD - Post Traumatic Stress Disorder; Depression Disorders; Dissociation; Refugee

Keywords

PTSD; Depression Disorders; Dissociation; Ukrainian Refugees; Norway; Narrative Exposure Therapy

Outcome Measures

Primary Outcomes (3)

• PTSD Symptom Severity (ITQ)

  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)

  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)

  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)

  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)

  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)

  Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)

Secondary Outcomes (1)

• Exposure to Traumatic Events (LEC-5)

  Baseline

Other Outcomes (8)

• Age

  Baseline

• Gender

  Baseline

• Marital status

  Baseline

Study Arms (2)

Case

EXPERIMENTAL

Participants assigned to that arm receive Narrative Exposure Therapy (intervention) immediately after the baseline screening

Behavioral: Narrative Exposure Therapy

Control

NO INTERVENTION

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.

Interventions

Narrative Exposure Therapy BEHAVIORAL

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.

Case

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kristiania University College: lead
• University of Konstanz: collaborator
• Oswaldo Cruz Foundation: collaborator
• Mental helse: collaborator
• Vårsta Diakoni: collaborator
• Norsk-Ukrainsk hjelpeorganisasjon: collaborator
• The Dam Foundation: collaborator

Study Sites (1)

Kristinia University of Applied Sciences

Oslo, 0187, Norway

RECRUITING

Related Publications (12)

• Schauer M, Neuner F, Elbert T. Narrative Exposure Therapy (NET) For Survivors of Traumatic Stress. 3 ed: Hogrefe Publishing; 2025

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• Ardino V, Schalinski I. Recent developments of narrative exposure therapy. Maltrattamento e Abuso All'Infanzia: Rivista Interdisciplinare. 2020;.22(3):pp

  BACKGROUND

• Tracy SJ. A phronetic iterative approach to data analysis in qualitative research. 질적연구. 2018;19(2):61-76

  BACKGROUND

• 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.

  PMID: 31007868 BACKGROUND

• 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.

  PMID: 33617284 BACKGROUND

• 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.

  PMID: 41143444 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Combat Disorders; Dissociative Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Vanessa Nolasco Ferreira, Associate Professor, PhD

  Kristiania University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Nolasco Ferreira, Associate Professor, PhD

CONTACT

+4741231069; vanessanolasco.ferreira@kristiania.no

Ashley Rebecca Bell-Mizori, Master in Psychology

CONTACT

vanessanolasco.ferreira@kristiania.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study utilizes a parallel-group randomized controlled trial design. Participants will be randomly assigned to one of two groups: an intervention group, which will receive Narrative Exposure Therapy (NET), and a waitlist control group, which will receive treatment after the initial study period (when the post-treatment screening of the participant that is matching case for each control case is concluded). 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.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 14, 2025
• Study Start: March 1, 2025
• Primary Completion: December 20, 2025
• Study Completion: April 20, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

NO (1)