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
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