Study of the Effectiveness of VRET Combined With tDCS in the Treatment of PTSD in Ukrainian Veterans and Civilians
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: Age · The participant is 18 to 75 years of age, inclusive, at the time the informed consent form (ICF) is signed. Type of Participant and Disease Characteristics: * The participant has a current diagnosis of PTSD as defined by the CAPS-5, with a CAPS-5 Total Symptom Severity Score of ≥30 at the Screening Visit and Baseline Visit and no \>25% change in score from Screening to Baseline. * The participant's index trauma event must have occurred when the participant was ≥13 years of age. 1. In the opinion of the Investigator the participant has a high probability for adherence with and completion of the study. 2. The participant has the ability to comply with study procedures. 3. The participant is fluent in Ukrainian and able to understand and comply with written and verbal protocol-related requirements. 4. The participant has received study inclusion approval through a