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RecruitingNAINTERVENTIONAL

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

This study is looking for better ways to help people in Ukraine, including veterans and civilians, who are suffering from Post-Traumatic Stress Disorder (PTSD). PTSD can happen after very upsetting experiences, like war, causing difficult memories, nightmares, and anxiety. Researchers are testing two treatments: virtual reality therapy, which uses special goggles to help people safely face upsetting memories, and gentle brain stimulation (tDCS), which might help the brain manage emotions better. The main goal is to find out if using both treatments together is more effective than virtual reality therapy alone. This research hopes to improve how PTSD is treated for many people in the future.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Malek Bajbouj
Enrolment target
514
Start
22 Apr 2025
Estimated completion
30 Jun 2027

What is this study about?

This important study is designed to help Ukrainian veterans and civilians who are struggling with Post-Traumatic Stress Disorder (PTSD). PTSD can develop after someone experiences a very distressing or traumatic event, such as those that can happen during war. People with PTSD might have upsetting memories or nightmares, feel constantly on edge, or try to avoid anything that reminds them of the event. Because so many people in Ukraine have been affected by conflict, finding effective treatments is very important.

The researchers are looking into two new ways to treat PTSD. One is called Virtual Reality Therapy. This uses special goggles to create a safe, virtual world where people can explore and process their difficult memories and emotions with the help of a therapist. The other treatment is called Brain Stimulation Therapy (tDCS). This involves a very mild electrical current applied to the scalp, which aims to help the brain better control emotions and manage stress.

The main aim of this study is to see if combining these two treatments – virtual reality and brain stimulation – works even better than using virtual reality therapy on its own. If successful, this combined approach could offer a new and improved way to help people recover from PTSD, making a real difference to their daily lives and emotional well-being. It also has the potential to help others with PTSD around the world in the future.

Key takeaways

  • This study is testing a new combination treatment for PTSD.
  • It uses virtual reality therapy and gentle brain stimulation.
  • The goal is to help Ukrainian veterans and civilians affected by war.
  • Potential benefits include reduced anxiety, depression, and improved coping skills.
  • Participants will attend 10 therapy sessions involving goggles and potentially brain stimulation.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old. You must have a clear diagnosis of PTSD that happened at least six months ago, and your experience must have occurred when you were 13 or older. It's important that you don't have ongoing exposure to the original traumatic event, as this study is for those who are in a stable environment.

There are certain things that would mean you can't take part. For example, if you have epilepsy, have had severe brain injuries, or have electronic devices implanted in your body like a pacemaker. If you are pregnant or have certain skin issues on your scalp, you also wouldn't be able to join. The study staff will talk to you thoroughly to make sure if this study is right for you, and that you can understand and follow the study instructions, which will be given in Ukrainian.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 75 years old?
  2. Do you have a diagnosis of PTSD?
  3. Did your traumatic event happen at least 6 months ago, and when you were 13 or older?
  4. Do you not have ongoing exposure to the original traumatic event?
  5. Are you not pregnant and do not have epilepsy or a pacemaker?
Answer every question to see your result.

What does participation involve?

If you join this study, you will have 10 therapy sessions over several weeks. During these sessions, you will use special virtual reality goggles. Alongside a therapist, you'll explore safe virtual scenarios that relate to your memories. Some of these sessions might also involve gentle brain stimulation therapy, where a mild electrical current is applied to your scalp. You'll also learn relaxation techniques to help you manage stress and improve your emotional control. The study will involve regular check-ups to see how you are doing, but the exact duration of your involvement isn't specified beyond the 10 sessions.

Potential risks and benefits

Taking part in this study could potentially help reduce your PTSD symptoms, such as upsetting memories, anxiety, and feelings of depression. You might also find yourself feeling calmer, more able to cope, and better at managing daily life. As with any study, there could be some mild side effects from the treatments, such as temporary tingling from the brain stimulation or feeling a bit overwhelmed by the virtual reality at first. You will be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Charité - Universitätsmedizin Berlin
    Verified postcode
    Berlin, Germany· Recruiting

Common questions

What is PTSD?

PTSD, or Post-Traumatic Stress Disorder, can happen after a very stressful or upsetting experience. It can cause ongoing difficult memories, nightmares, feeling constantly nervous, or trying to avoid things that remind you of the event.

What is virtual reality therapy?

Virtual reality therapy uses special goggles to create a safe, computer-generated world. In this world, you can work with a therapist to gradually face and understand memories and emotions linked to your past experiences.

What is brain stimulation therapy (tDCS)?

This therapy involves a very gentle electrical current applied to your scalp. It aims to help your brain improve how it manages emotions and stress.

How many sessions are involved?

If you take part, you will attend 10 therapy sessions over several weeks.

Will I have to pay to be in the study?

No, clinical trials do not typically charge participants. All study-related treatments and assessments are provided free of charge.

How to find out more

Yuliya Kovalchuk, M.Sc.

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study of the Effectiveness of VRET Combined With tDCS in the…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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