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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMalek Bajbouj

About this trial

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

Qualifiers

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.

In the opinion of the Investigator the participant has a high probability for adherence with and completion of the study.

The participant has the ability to comply with study procedures.

Disqualifiers

Individuals with Epilepsy, Seizures or Severe Brain Injuries

Individuals with Implanted Electronic Devices (Pacemakers, Cochlear Implants, etc.)

Individuals with Scalp or Skin Issues at electrode placement sites

Pregnant Individuals

Trial design

Treatments tested in this trial

  • Virtual reality exposure therapy
  • transcranial direct current stimulation
  • Imaginal exposure therapy

Treatment groups

514 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Malek Bajbouj

Lead sponsor

Charite University, Berlin, Germany

Sponsor institution

Bogomolets National Medical University

Collaborator

Khmelnytsky Regional Institution for psychiatric care

Collaborator

Ternopil Regional Clinical Psychoneurological Hospital

Collaborator

Danylo Halytsky Lviv National Medical University

Collaborator

Dnipropetrovsk Clinical Multidisciplinary Hospital for Psychiatric Care

Collaborator

Clinical Hospital 'Psychiatry' of the executive body of the Kyiv City Council

Collaborator