PTSD - Post Traumatic Stress DisorderENNCT07062042
Empowering Narratives
A study testing Narrative Exposure Therapy in people with PTSD - Post Traumatic Stress Disorder and Depression Disorders, run by Kristiania University College at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, Depression Disorders, Dissociation
- What is being tested?
- Narrative Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2025to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vanessa Nolasco Ferreira, Associate Professor, PhD contact
Ashley Rebecca Bell-Mizori, Master in Psychology contact
Norway1 site, 1 recruiting
- Recruiting
Kristinia University of Applied Sciences
Oslo, 0187
Vanessa Nolasco Ferreira, Associate Professor, PhD, +4741231069, vanessanolasco.ferreira@kristiania.no
Ashley Rebecca Bell-Mizori, Master in Psychology, +4747380473, ashleyrebecca.bell-mizori@kristiania.no
About this study
Official title: Styrkende Narrativ: Hjelp Til Selvhjelp for Ukrainske Flyktninger / Empowering Narratives: Help to Self-help to Ukrainian Refugees
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.
Read the detailed description
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.
- Being tested
- Narrative Exposure Therapy
- Keywords
- PTSD, Depression Disorders, Dissociation, Ukrainian Refugees, Norway, Narrative Exposure Therapy
- Medical subject headings
- Combat Disorders, Dissociative Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Case | Experimental | Participants assigned to that arm receive Narrative Exposure Therapy (intervention) immediately after the baseline screening Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Mar 2025
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kristiania University College
- Sponsor type
- University, hospital or other
- Collaborators
- University of Konstanz, Oswaldo Cruz Foundation, Mental helse, Vårsta Diakoni, Norsk-Ukrainsk hjelpeorganisasjon, The Dam Foundation
- Responsible party
- Sponsor
- Investigators
- Vanessa Nolasco Ferreira, Associate Professor, PhD, Principal investigator, Kristiania University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062042
- Sponsor's protocol ID
- Styrkende Narrativ Kristiania
- Other IDs
- 547119
- Acronym
- EN
- Status last verified
- Aug 2025
- First submitted
- 10 Jun 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 11556941Cloitre 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.
PubMed 30178492Gray 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.
PubMed 15486169Schalinski 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.
PubMed 25976478Labberton 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.
PubMed 39533254Labberton 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.
PubMed 31007868Wei 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.
PubMed 33617284Ferreira 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.
PubMed 41143444
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Styrkende Narrativ: Hjelp Til Selvhjelp for Ukrainske Flyktninger / Empowering Narratives: Help to Self-help to Ukrainian Refugees
- ClinicalTrials.gov ID
- NCT07062042
- Acronym / sponsor ID
- EN / Styrkende Narrativ Kristiania
- Keywords
- PTSD, Depression Disorders, Dissociation, Ukrainian Refugees, Norway, Narrative Exposure Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kristiania University CollegeUniversity, hospital or other
- Collaborators
- University of Konstanz, Oswaldo Cruz Foundation, Mental helse, Vårsta Diakoni, Norsk-Ukrainsk hjelpeorganisasjon, The Dam Foundation
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Case | Experimental | Behavioral: Narrative Exposure TherapyParticipants assigned to that arm receive Narrative Exposure Therapy (intervention) immediately after the baseline screening |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative Exposure TherapyNarrative 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. | Behavioural | Case |
Primary outcome
PTSD Symptom Severity (ITQ)
Time frame: Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)
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)
Dissociation Symptoms (Shut-D)
Time frame: Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)
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)
Depression Symptoms (PHQ-9)
Time frame: Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)
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)
1 secondary outcome
Exposure to Traumatic Events (LEC-5)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- BackgroundSchauer M, Neuner F, Elbert T. Narrative Exposure Therapy (NET) For Survivors of Traumatic Stress. 3 ed: Hogrefe Publishing; 2025
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 30178492Cloitre 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.
- Background: PubMed 15486169Gray 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.
- Background: PubMed 25976478Schalinski 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.
- Background: PubMed 39533254Labberton 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.
- BackgroundLabberton 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.
- BackgroundArdino V, Schalinski I. Recent developments of narrative exposure therapy. Maltrattamento e Abuso All'Infanzia: Rivista Interdisciplinare. 2020;.22(3):pp
- BackgroundTracy SJ. A phronetic iterative approach to data analysis in qualitative research. 질적연구. 2018;19(2):61-76
- Background: PubMed 31007868Lely 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.
- Background: PubMed 33617284Wei 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.
- Derived from this study: PubMed 41143444Ferreira 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.
- UNHCR. The Operational Data Portal 2025Link provided by the sponsor.
- TSD, Tjenester for Sensitive Data - secure data storage serverLink provided by the sponsor.
- Nettskjema - secure questionnaire data collection toolLink provided by the sponsor.
- SIKT - Norwegian Agency for Shared Services in Education and ResearchLink provided by the sponsor.
- REK - Norwegian Regional Committee for Medical and Health Research EthicsLink provided by the sponsor.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vanessa Nolasco Ferreira, Associate Professor, PhD contact
Ashley Rebecca Bell-Mizori, Master in Psychology contact
Vanessa Nolasco Ferreira, Associate Professor, PhD principal investigator
Kristiania University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Exposure Therapy in people with PTSD - Post Traumatic Stress Disorder and Depression Disorders, run by Kristiania University College at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Nolasco Ferreira, Associate Professor, PhD (+4741231069, vanessanolasco.ferreira@kristiania.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptom Severity (ITQ) (time frame: Baseline, Post-treatment (one to seven days after the last treatment session), 6-month Follow-up (counted after the post-treatment screening)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07062042, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.