RecruitingNot ApplicableNCT06806267

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

Study of the Effectiveness of Virtual Exposure Therapy (VRET) in Combination With Transcranial Direct Current Stimulation (tDCS) in the Treatment of Veterans and Civilians With PTSD in Wartime Ukraine


Sponsor

Malek Bajbouj

Enrollment

514 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of virtual reality exposure therapy (VRET) — where patients safely face trauma-related situations in a virtual environment — and a mild brain stimulation technique (tDCS) for treating PTSD in Ukrainian-speaking adults. **You may be eligible if...** - You are between 18 and 75 years old - You have a current diagnosis of PTSD with significant symptoms (based on a standardized assessment scale) - Your traumatic event happened when you were 13 or older, and at least 6 months have passed since it occurred - You are fluent in Ukrainian and able to follow written and spoken instructions **You may NOT be eligible if...** - You have epilepsy, seizures, or a severe brain injury - You have an implanted electronic device such as a pacemaker or cochlear implant - You have skin problems at the electrode placement sites on your scalp - You are pregnant - You have tinnitus (ringing in the ears) - You are still being actively exposed to the traumatic situation that caused your PTSD - You have complex PTSD (from prolonged trauma such as torture or repeated childhood abuse) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVirtual reality exposure therapy

Exposure therapy applied through virtual reality goggles, controlled by a clinician

DEVICEtranscranial direct current stimulation

transcranial direct current stimulation applied to the vmpfc, 2mA

BEHAVIORALImaginal exposure therapy

Imaginal exposure therapy


Locations(1)

Charité - Universitätsmedizin Berlin

Berlin, Germany

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NCT06806267


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