Building Ukraine's Strength in PTSD Treatment and Research

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Luxembourg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Reconsolidation of Traumatic Memories Protocol

    Behavioral

    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.

  • Trauma-Focused Cognitive Behavioral Therapy

    Behavioral

    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

    Behavioral

    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

    Drug

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Arm A: RTM ProtocolExperimental treatment 1 intervention
Group B: Arm B: Treatment-as-Usual (TAU)Active comparator 3 interventions

Trial outcomes

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.

Time frame
Data collection will occur at baseline, 1 month after complete treatment application, in 6 months, and in 12 months.

Secondary outcomes

1

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.

Time frame
Data collection will occur at baseline, 1 month after complete treatment application, in 6 months, and in 12 months.
2

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.

Time frame
Data collection will occur at baseline, 1 month after complete treatment application, in 6 months, and in 12 months.

Other outcomes

1

Satisfaction with the therapeutic procedure for clients assessed using an 11-item Likert-scale questionnaire

Satisfaction with the therapeutic procedure will be assessed using an 11-item Likert-scale questionnaire designed for mental health professionals. The questionnaire covers three domains: Process Comfort, Expected and Reached Results, and Changes in Trauma Narrative. Each item is rated from 1 (Strongly disagree) to 5 (Strongly agree), with total scores ranging from 11 to 55. Higher scores indicate greater satisfaction with the treatment process and outcomes.

Time frame
Up to 24 hours after completion of treatment.
2

Satisfaction with the therapeutic procedure for mental health professionals assessed using an 11-item Likert-scale questionnaire

Satisfaction with the therapeutic procedure will be assessed using an 11-item Likert-scale questionnaire designed for mental health professionals. The questionnaire covers three domains: Process Comfort, Expected and Reached Results, and Changes in Trauma Narrative. Each item is rated from 1 (Strongly disagree) to 5 (Strongly agree), with total scores ranging from 11 to 55. Higher scores indicate greater satisfaction with the therapeutic process and perceived effectiveness for clients.

Time frame
Post-treatment completion (up to 1 week after the last assigned client session).
3

Usability of the RTM Protocol assessed using the Intervention Usability Scale

Usability of the RTM Protocol will be assessed using the standardized Intervention Usability Scale, which consists of 10 items evaluating perceived ease of use, complexity, integration of components, confidence in use, and need for support. Each item is rated on a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree), with total scores ranging from 10 to 50. Higher scores indicate greater usability and confidence in applying the RTM Protocol.

Time frame
Post-treatment completion (up to 1 week after the last assigned client session).
4

MH professionals' feedback

The feedback of MH professionals will also be considered during the focus group analysis. The script previews topics such as the RTM Protocol use features, the RTM Protocol implementation benefits and challenges, the RTM Protocol effects and consequences, the RTM Protocol clients' acceptance and perception, etc.

Time frame
Post-treatment completion (up to 1 week after the last assigned client session).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Luxembourg

Lead sponsor

National Psychological Association of Ukraine

Collaborator

Veteran Mental Health and Rehabilitation Center 'Forest Glade' Ministry of Health of Ukraine

Collaborator

Quresta, Inc.

Collaborator