Fostering Ukraine's Capacity in the Delivery and Research of Innovative Evidence-based PTSD Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- PTSD symptoms according to the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
研究概览
简要总结
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.
详细描述
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 trauma-related symptoms without requiring patients to retell their traumatic experiences in detail.
The Russian invasion of Ukraine has led to a steep rise in PTSD prevalence. Recent studies show that 30-50% of civilians, 55% of internally displaced persons, and over 60% of refugees present with PTSD symptoms, while combat-related PTSD among military personnel is widespread. The Ukrainian mental health system, although reforming toward community-based care, lacks sufficient evidence-based tools to address this unprecedented demand.
Traditional trauma therapies such as trauma-focused cognitive behavioural therapy (TF-CBT), exposure therapy, and eye movement desensitization and reprocessing (EMDR) are recommended by international guidelines and effective in many settings. However, they require lengthy treatment, demand that patients retell traumatic events, and often show high dropout rates (up to 30%). In contrast, RTM Protocol has demonstrated rapid and lasting reductions in PTSD symptoms, often in three to five sessions, with low dropout rates. Randomized controlled trials in the USA and UK report diagnostic remission in 70-88% of veterans treated, with sustained results up to a year post-treatment. These features make RTM Protocol particularly promising for conflict-affected populations where resources are limited and stigma or retraumatization hinder treatment.
A cornerstone of the project is training 20 Ukrainian mental health professionals in the delivery of the RTM Protocol. Training is conducted by Quresta Inc. (USA) in collaboration with the University of Luxembourg, followed by biweekly supervision and accreditation. This ensures both fidelity to the protocol and sustainability. Trained professionals will continue applying RTM beyond the project, potentially treating many trauma survivors in the years ahead.
Data will be collected, pseudonymized in Ukraine by implementing partners - the Centre of Mental Health and Rehabilitation "Forest Glade" of the Ministry of Health of Ukraine (RCFG) and the National Psychological Association of Ukraine (NPAU), and transferred in fully anonymized, aggregated form to the University of Luxembourg for analysis. Findings will inform humanitarian response policy and sustainable capacity-building for evidence-based PTSD treatment in low-resource, conflict settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm 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.
干预措施: Reconsolidation of Traumatic Memories Protocol (Behavioral)
Arm 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 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)
干预措施: Trauma-Focused Cognitive Behavioral Therapy (Behavioral)
Arm 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 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)
干预措施: Eye Movement Desensitization and Reprocessing (Behavioral)
Arm 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 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)
干预措施: Selective Serotonin Reuptake Inhibitors: Paroxetine, Sertraline (Drug)
结局指标
主要结局
PTSD symptoms according to the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
时间窗: Data collection will occur at baseline, 1 month after complete treatment application, in 6 months, and in 12 months.
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.
次要结局
- 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.)
研究者
Viktoriia GORBUNOVA
Sc.D, Research Scientist
University of Luxembourg
