Empowering Narratives
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKristiania University College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ukrainian refugee residing in Norway.
Arrival in Norway after 24 February 2022.
Minimum 18 years old
Provided informed consent for participation.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Narrative Exposure Therapy
BehavioralNarrative 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: CaseExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)
Time frame
Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)2
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)
Time frame
Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)3
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)
Time frame
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)
Captures direct and indirect exposure to 17 categories of potentially traumatic events, including whether the event "happened to me." Instrument: Life Events Checklist for DSM-5 (LEC-5) Association between level of trauma exposure and symptom severity (H7)
Time frame
BaselineOther outcomes
1
Age
Age in years
Time frame
Baseline2
Gender
Male, Female
Time frame
Baseline3
Marital status
Single, have never been married; Married/co-habiting; Divorced/separated - within last year; Divorced/separated - for more than 1 year; Widow/Widower - within last year; Widow/Widower - for more than 1 year. Analytical Use: Covariates or moderators in outcome models
Time frame
Baseline4
Education
Primary (less than 7 grades); Incomplete secondary (less than 10 grades); Trade factory apprenticeship or professional courses after 7-8 grades; Completed secondary (10-11 grades); Trade factory apprenticeship or professional courses after 10-11 grades; Secondary technical education; Uncompleted higher education (3 courses or less); Completed higher education. Instrument: Custom questionnaire Analytical Use: Covariates or moderators in outcome models
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kristiania University College
Lead sponsor
University of Konstanz
Collaborator
Oswaldo Cruz Foundation
Collaborator
Mental helse
Collaborator
Vårsta Diakoni
Collaborator
Norsk-Ukrainsk hjelpeorganisasjon
Collaborator
The Dam Foundation
Collaborator
Source ClinicalTrials.gov