[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617404":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":46,"centralContacts":50,"locations":55,"responsibleParty":83,"collaborators":86,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":40,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":58,"whyStopped":40,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"University of Luxembourg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: RTM Protocol","EXPERIMENTAL","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.",[13],"Behavioral: Reconsolidation of Traumatic Memories Protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B: Treatment-as-Usual (TAU)","ACTIVE_COMPARATOR","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:\u002F\u002Fwww.dec.gov.ua\u002Fwp-content\u002Fuploads\u002F2024\u002F07\u002F1265\\_19072024\\_ykpmd\\_ptsr\\_dod.pdf)",[19,20,21],"Behavioral: Trauma-Focused Cognitive Behavioral Therapy","Behavioral: Eye Movement Desensitization and Reprocessing","Drug: Selective Serotonin Reuptake Inhibitors: Paroxetine, Sertraline",[23,30,36,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BEHAVIORAL","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 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.",[9],[29],"RTM Protocol",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"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.",[15],[35],"TF-CBT",{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"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.",[15],null,{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":40},"DRUG","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, making them suitable for long-term use.",[15],[47],{"name":48,"affiliation":5,"role":49},"Viktoriia V Gorbunova, ScD","PRINCIPAL_INVESTIGATOR",[51],{"name":48,"role":52,"phone":53,"phoneExt":40,"email":54},"CONTACT","+352621749295","viktoriia.gorbunova@uni.lu",[56,73],{"facility":57,"status":58,"city":59,"state":40,"zip":40,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"National Psychological Association of Ukraine","RECRUITING","Kyiv","Ukraine","UA",{"type":63,"coordinates":64},"Point",[65,66],30.5238,50.45466,{"lat":66,"lon":65},[69],{"name":70,"role":52,"phone":71,"phoneExt":40,"email":72},"Valeriia Palii, PhD","+380956109308","palii.valeriia@gmail.com",{"facility":74,"status":58,"city":59,"state":40,"zip":40,"country":60,"countryCode":61,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Veteran Mental Health and Rehabilitation Center 'Forest Glade' Ministry of Health of Ukraine",{"type":63,"coordinates":76},[65,66],{"lat":66,"lon":65},[79],{"name":80,"role":52,"phone":81,"phoneExt":40,"email":82},"Tetiana Sirenko","+380681017683","tanya.sirenko@gmail.com",{"type":49,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Viktoriia GORBUNOVA","Sc.D, Research Scientist",[87,89,90],{"name":57,"class":88},"UNKNOWN",{"name":74,"class":88},{"name":91,"class":88},"Quresta, Inc.","100617404","building-ukraines-strength-in-ptsd-treatment-and-research-100617404",false,"NCT07318181","Building Ukraine's Strength in PTSD Treatment and Research","Fostering Ukraine's Capacity in the Delivery and Research of Innovative Evidence-based PTSD Treatment","Lux4UA","Inclusion Criteria:\n\n1. being adults 18-65 years,\n2. having a diagnosis of PTSD determined by DSM-5-TR or ICD-11 and\u002For\n3. 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,\n4. being a resident of Ukraine.\n\nExclusion Criteria:\n\n1. having any other acute comorbid mental health conditions,\n2. receiving any other parallel PTSD treatment,\n3. being unable to provide informed consent, having severe cognitive impairment, or being otherwise unlikely to adhere to study procedures.","ALL","18 Years","65 Years",{"count":104,"type":105},120,"ESTIMATED","INTERVENTIONAL",[108],"NA","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.\n\nThis 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.\n\nThe 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.\n\nA 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.\n\nTo 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.",[111,112,113],"Post Traumatic Stress Disorder","Post Traumatic Stress Disorder PTSD","Post-Traumatic Stress Disorder, PTSD",[111,115,29,116,117,118,119],"RTM","PTSD","trauma therapy","traumatic memories","memory reconsolidation","2026-01-14",{"date":122,"type":123},"2026-01-15","ACTUAL",{"date":125,"type":123},"2026-01-01",{"date":127,"type":105},"2028-05",{"name":5,"class":6},2]