Building Ukraine's Strength in PTSD Treatment and Research
Lux4UA
Fostering Ukraine's Capacity in the Delivery and Research of Innovative Evidence-based PTSD Treatment
2 other identifiers
interventional
120
1 country
2
Brief Summary
The Lux4UA project aims to support mental health treatment in Ukraine, especially for those who have experienced traumatic events due to the ongoing conflict and forced displacement. As rates of Post-Traumatic Stress Disorder (PTSD) rise among civilians, military personnel, and refugees, the need for effective trauma care becomes urgent. PTSD is a mental health condition that can develop after experiencing trauma, leading to flashbacks, nightmares, anxiety, and other symptoms that significantly impact daily life. This project introduces an innovative method called the Reconsolidation of Traumatic Memories (RTM) Protocol, which helps individuals reduce distressing memories and trauma-related symptoms. Unlike traditional therapies, the RTM Protocol aims to quickly alleviate PTSD symptoms without requiring patients to relive or discuss in detail their traumatic experiences, which can sometimes be overwhelming. Instead, it employs carefully guided imaginary exercises to help patients reprocess and feel less emotional distress when recalling traumatic memories. This structured approach can lead to significant improvements in just three to five sessions. The Lux4UA project brings together mental health professionals and researchers from Ukraine, Luxembourg, and the United States to test how well this treatment works in Ukraine and to understand if it can be easily integrated into the country's mental health system. By studying the RTM Protocol in three main settings-hospital care and outpatient (walk-in) clinics for veterans and therapy practices for civilians-the project will assess the treatment's effectiveness for people with different needs and backgrounds. It will also evaluate how comfortable and satisfied both mental health practitioners and patients are with the treatment. A key part of the project is training Ukrainian mental health professionals in the RTM Protocol. This training ensures that local mental health professionals are well-prepared to deliver the treatment and support trauma survivors long after the project ends, building a sustainable mental health system in Ukraine. The project will involve careful monitoring of how patients respond to the treatment, paying special attention to their well-being throughout each session. To evaluate the treatment's success, the project will measure changes in PTSD symptoms, as well as signs of anxiety and depression that often accompany trauma. The project will also assess the RTM Protocol's adaptability to Ukrainian needs, seeing if any modifications are necessary to better suit the local context.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
January 15, 2026
January 1, 2026
1.8 years
November 28, 2025
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PTSD symptoms according to the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure with scores ranging from 0 to 80, with each item rated on a scale from 0 (Not at all) to 4 (Extremely). Higher scores indicate worse outcomes, reflecting greater severity of PTSD symptoms, while lower scores suggest fewer or less severe symptoms.
Data collection will occur at baseline, 1 month after complete treatment application, in 6 months, and in 12 months.
Secondary Outcomes (2)
Anxiety-related symptoms according to the Generalized Anxiety Disorder-7 (GAD-7)
Data collection will occur at baseline, 1 month after complete treatment application, in 6 months, and in 12 months.
Depression-related symptoms according to the Patient Health Questionnaire-9 (PHQ-9)
Data collection will occur at baseline, 1 month after complete treatment application, in 6 months, and in 12 months.
Other Outcomes (4)
Satisfaction with the therapeutic procedure for clients assessed using an 11-item Likert-scale questionnaire
Up to 24 hours after completion of treatment.
Satisfaction with the therapeutic procedure for mental health professionals assessed using an 11-item Likert-scale questionnaire
Post-treatment completion (up to 1 week after the last assigned client session).
Usability of the RTM Protocol assessed using the Intervention Usability Scale
Post-treatment completion (up to 1 week after the last assigned client session).
- +1 more other outcomes
Study Arms (2)
Arm A: RTM Protocol
EXPERIMENTALRTM Protocol - A manualised, algorithmic, imagery-based procedure delivered in 3-5 sessions (\~90 minutes each) on consecutive days or with at least one sleep cycle between sessions.
Arm B: Treatment-as-Usual (TAU)
ACTIVE COMPARATORTreatment-as-Usual (TAU) - Evidence-based care per routine practice (TF-CBT or EMDR or Selective Serotonin Reuptake Inhibitors) following organisational and professional standards in Ukraine. All interventions in this arm are approved in Ukraine (see Ministry of Health of Ukraine. (2024). Unifikovanyi klinichnyi protokol. Hostra reaktsiia na stres. Posttravmatychnyi stresovyi rozlad. Porushennia adaptatsii \[Clinical protocol for acute stress reactions, post-traumatic stress disorder (PTSD), and adaptation disorders\] (Order No. 1265). Ministry of Health of Ukraine. https://www.dec.gov.ua/wp-content/uploads/2024/07/1265\_19072024\_ykpmd\_ptsr\_dod.pdf)
Interventions
The protocol as a structured, mandatory-to-administrate 89-step procedure consists of three main phases: Pre-treatment, Treatment, and Retelling of the Trauma Event. Aside from establishing therapeutic rapport and framing the work, one of the key tasks in the Pre-treatment phase is the Visual Formats Practice. This involves specially organised exercises that help a person engage in imaginative activities with neutral events, preparing them to do similar work addressing trauma in the subsequent steps. The Treatment phase implies leading a person through three types of Visual Formats, specific techniques used to help clients visualise the trauma story in a way that minimises the distress of recalling. The Retelling of the Trauma Event phase intersperses with Visual Formats and serves to assess of so-called subjective distress throughout persons' retelling of traumatic events.
TF-CBT is designed to help individuals process and recover from traumatic experiences by integrating trauma-sensitive strategies with cognitive-behavioral techniques. It combines psychoeducation, relaxation strategies, emotional regulation, cognitive restructuring, and the development of a trauma narrative to reduce symptoms of PTSD, anxiety, and depression.
EMDR is a structured, evidence-based psychotherapy designed to help individuals process and heal from traumatic experiences by using bilateral stimulation, typically guided eye movements, while recalling distressing memories. EMDR does not require detailed discussion of the trauma or homework between sessions.
Paroxetine and Sertraline, both SSRIs, are distinguished in PTSD treatment by their strong evidence base and official FDA approval specifically for this condition. They effectively target core PTSD symptoms such as intrusive thoughts, hyperarousal, and emotional numbing by enhancing serotonin regulation. Compared to other pharmacological options, SSRIs offer superior safety, tolerability, and dosing flexibility, making them suitable for long-term use.
Eligibility Criteria
You may qualify if:
- being adults 18-65 years,
- having a diagnosis of PTSD determined by DSM-5-TR or ICD-11 and/or
- having PTSD symptoms causing clinically significant distress or impact on social, occupational, or other areas of functioning, as defined by the PTSD Checklist PCL-5,
- being a resident of Ukraine.
You may not qualify if:
- having any other acute comorbid mental health conditions,
- receiving any other parallel PTSD treatment,
- being unable to provide informed consent, having severe cognitive impairment, or being otherwise unlikely to adhere to study procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Psychological Association of Ukraine
Kyiv, Ukraine
Veteran Mental Health and Rehabilitation Center 'Forest Glade' Ministry of Health of Ukraine
Kyiv, Ukraine
Related Publications (3)
Gorbunova V, Hampton R. The Reconsolidation of Traumatic Memories Protocol's adjustments to the remote treatment of injured Ukrainian military personnel in hospital settings. Eur J Psychotraumatol. 2025 Dec;16(1):2499410. doi: 10.1080/20008066.2025.2499410. Epub 2025 May 19.
PMID: 40387497RESULTSturt J, Rogers R, Armour C, Cameron D, De Rijk L, Fiorentino F, Forbes T, Glen C, Grealish A, Kreft J, Meye de Souza I, Spikol E, Tzouvara V, Greenberg N. Reconsolidation of traumatic memories protocol compared to trauma-focussed cognitive behaviour therapy for post-traumatic stress disorder in UK military veterans: a randomised controlled feasibility trial. Pilot Feasibility Stud. 2023 Oct 13;9(1):175. doi: 10.1186/s40814-023-01396-x.
PMID: 37833734RESULTAstill Wright L, Horstmann L, Holmes EA, Bisson JI. Consolidation/reconsolidation therapies for the prevention and treatment of PTSD and re-experiencing: a systematic review and meta-analysis. Transl Psychiatry. 2021 Sep 3;11(1):453. doi: 10.1038/s41398-021-01570-w.
PMID: 34480016RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Viktoriia V Gorbunova, ScD
University of Luxembourg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sc.D, Research Scientist
Study Record Dates
First Submitted
November 28, 2025
First Posted
January 5, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
May 1, 2028
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared outside the therapists and research coordinators who will collect data. This decision is based on the high sensitivity of the data, which involves trauma histories and mental health information from children. Even with de-identification, the small sample size and the vulnerability of the population create a risk of re-identification. For these reasons, only anonymised data will be shared with researchers, and only aggregated results will be shared through publications and presentations.