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NCT06806267 · ClinicalTrials.gov record · last posted 2026-08-11

Study of the Effectiveness of VRET Combined With tDCS in the Treatment of PTSD in Ukrainian Veterans and Civilians

Study acronym: AVRE-U
StatusRecruiting
PhaseNot applicable
Started2025-04-22
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from the ClinicalTrials.gov record
A new method is being tested to assist individuals in Ukraine with Post-Traumatic Stress Disorder (PTSD), including veterans and civilians affected by war. The study is a collaboration among Ukrainian healthcare institutions and the Charité Berlin. What is PTSD? PTSD can occur after a distressing or traumatic experience, such as exposure to war. It can result in persistent negative memories, nightmares, heightened nervousness, or avoidance of reminders associated with the event. Purpose of the Study Two innovative treatments for PTSD are being tested: 1. Virtual Reality Therapy: This approach uses specialized goggles to create a safe and realistic virtual environment where individuals can confront memories and process emotions with guidance from a therapist. 2. Brain Stimulation Therapy (tDCS): This method applies a gentle electrical current to the scalp to support improved emotional regulation by the brain. The study aims to determine whether combining these two treatments is more effective than using virtual reality therapy alone. Participant Involvement Participants will: * Attend 10 therapy sessions over several weeks. * Use virtual reality goggles to engage with safe scenarios related to their memories, guided by a therapist. * Potentially receive brain stimulation therapy during some virtual reality sessions. * Learn relaxation techniques to help manage stress and enhance emotional control. Potential Benefits for Participants * These treatments may reduce symptoms such as intrusive memories, anxiety, and depression. * Participants may experience increased calmness, resilience, and improved ability to manage daily life. This study also has the potential to advance PTSD treatment methods for others in the future.

Protocol amendment history 1 change detected by DataLookout

2026-08-12
critical
Enrollment reduced: 514 → 100 participants
Trial Details
NCT Number NCT06806267
Lead Sponsor Malek Bajbouj
Collaborators: Bogomolets National Medical University, Khmelnytsky Regional Institution for psychiatric care, Ternopil Regional Clinical Psychoneurological Hospital, Danylo Halytsky Lviv National Medical University, Dnipropetrovsk Clinical Multidisciplinary Hospital for Psychiatric Care, Clinical Hospital 'Psychiatry' of the executive body of the Kyiv City Council
Conditions PTSD - Post Traumatic Stress Disorder
Enrollment 100 participants
Start Date 2025-04-22
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-11