An interventional study of Narrative Exposure Therapy in PTSD - Post Traumatic Stress Disorder, Depression Disorders and Dissociation, sponsored by Kristiania University College. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Kristiania University College · Not applicable, Interventional, and Treatment
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.
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.
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →Kristiania University College is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to that arm receive Narrative Exposure Therapy (intervention) immediately after the baseline screening
Behavioral: Narrative Exposure Therapy
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.
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.
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)
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)
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)
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: Baseline
Age
Age in years
Time frame: Baseline
Gender
Male, Female
Time frame: Baseline
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: Baseline
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: Baseline
Long-term illness, health problem or handicap
Yes or No
Time frame: Baseline
General Perception of Health
Very good; Good ; Fair; Poor; Very poor.
Time frame: Baseline
Time in Norway
Patient reports during the first therapy session (lifeline session)
Time frame: Baseline
Functional Impairment
In the international trauma questionaire function impairment connected to PTSD is measured if At least one of P7, P8, or P9 \> 2 meets criteria for PTSD functional impairment (PTSDFI) If the patient meets the criteria for CPTSD the function impairment is measured if at least one of C7, C8, or C9 \> 2 meets criteria for DSO functional impairment (DSOFI) In what concerns depression, the measure will come from the question number 10 in PHQ9 if the patient answers somewhat difficult, difficult or very difficult. Embedded in: ITQ and PHQ-9 Outcome Focus: Supplementary analysis of clinical relevance
Time frame: Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — This study does not plan to share individual participant data (IPD) publicly. However, de-identified group-level results and relevant statistical outputs will be shared through peer-reviewed publication. A full study protocol will be submitted for peer review to the European Journal of Psychotraumatology, which adheres to ICMJE trial registration and transparency standards. The manuscript includes detailed methodological information, including hypotheses, intervention structure, outcome measures, and ethical safeguards. Upon publication, the protocol will be publicly accessible and cited in connection with the trial results.
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