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Clinical Trial NCT07318181 (Lux4UA) for Post Traumatic Stress Disorder, Post Traumatic Stress Disorder PTSD, Post-Traumatic Stress Disorder, PTSD is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Building Ukraine's Strength in PTSD Treatment and Research (Lux4UA) 120 Veterans Exercise-Based

Recruiting
Clinical Trial NCT07318181 (Lux4UA) is an interventional study for Post Traumatic Stress Disorder, Post Traumatic Stress Disorder PTSD, Post-Traumatic Stress Disorder, PTSD that is recruiting. It started on January 1, 2026 with plans to enroll 120 participants. Led by University of Luxembourg, it is expected to complete by May 1, 2028. The latest data from ClinicalTrials.gov was last updated on January 15, 2026.
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, le...Show More
Detailed Description
The Lux4UA Project aims to strengthen Ukraine's capacity to deliver and research innovative, evidence-based treatment for post-traumatic stress disorder (PTSD) in the context of ongoing war, displacement, and humanitarian crisis. The project evaluates the effectiveness and feasibility of the Reconsolidation of Traumatic Memories (RTM) Protocol - a short-term, neurobiologically grounded intervention that reduces traum...Show More
Official Title

Fostering Ukraine's Capacity in the Delivery and Research of Innovative Evidence-based PTSD Treatment

Conditions
Post Traumatic Stress DisorderPost Traumatic Stress Disorder PTSDPost-Traumatic Stress Disorder, PTSD
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • Lux4UA
  • U-AGR-7624-00
  • 19403469/LuxAid-Bridges (Other Grant/Funding Number) (The Luxembourg National Research Fund)
NCT ID Number
NCT07318181
Start Date (Actual)
2026-01-01
Last Update Posted
2026-01-15
Completion Date (Estimated)
2028-05
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Post Traumatic Stress Disorder
RTM
RTM Protocol
PTSD
trauma therapy
traumatic memories
memory reconsolidation
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalArm A: RTM Protocol
RTM 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.
Reconsolidation of Traumatic Memories Protocol
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...Show More
Active ComparatorArm B: Treatment-as-Usual (TAU)
Treatment-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...Show More
Trauma-Focused Cognitive Behavioral Therapy
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.
Eye Movement Desensitization and Reprocessing
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.
Selective Serotonin Reuptake Inhibitors: Paroxetine, Sertraline
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, maki...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Anxiety-related symptoms according to the Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is a 7-item self-report measure of anxiety severity, with scores ranging from 0 to 21, where each item is rated from 0 (Not at all) to 3 (Nearly every day). Higher scores indicate worse outcomes, reflecting greater severity of anxiety 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.
Depression-related symptoms according to the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9-item self-report measure of depression severity, with scores ranging from 0 to 27, where each item is rated from 0 (Not at all) to 3 (Nearly every day). Higher scores indicate worse outcomes, reflecting greater severity of depressive 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.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. being adults 18-65 years,
  2. having a diagnosis of PTSD determined by DSM-5-TR or ICD-11 and/or
  3. 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,
  4. being a resident of Ukraine.

  1. having any other acute comorbid mental health conditions,
  2. receiving any other parallel PTSD treatment,
  3. being unable to provide informed consent, having severe cognitive impairment, or being otherwise unlikely to adhere to study procedures.
University of Luxembourg logoUniversity of Luxembourg
Study Responsible Party
Viktoriia GORBUNOVA, Principal Investigator, Sc.D, Research Scientist, University of Luxembourg
Study Central Contact
Contact: Viktoriia V Gorbunova, ScD, +352621749295, [email protected]
2 Study Locations in 1 Countries
National Psychological Association of Ukraine, Kyiv, Ukraine
Valeriia Palii, PhD, Contact, +380956109308, [email protected]
Recruiting
Veteran Mental Health and Rehabilitation Center 'Forest Glade' Ministry of Health of Ukraine, Kyiv, Ukraine
Tetiana Sirenko, Contact, +380681017683, [email protected]
Recruiting