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

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.

Conditions

• PTSD - Post Traumatic Stress Disorder

Interventions

DEVICE

Virtual reality exposure therapy

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

DEVICE

transcranial direct current stimulation

transcranial direct current stimulation applied to the vmpfc, 2mA

BEHAVIORAL

Imaginal exposure therapy

Imaginal exposure therapy

Sponsors & Collaborators

• Bogomolets National Medical University

  collaborator OTHER

• Khmelnytsky Regional Institution for psychiatric care

  collaborator UNKNOWN

• Ternopil Regional Clinical Psychoneurological Hospital

  collaborator UNKNOWN

• Danylo Halytsky Lviv National Medical University

  collaborator OTHER

• Dnipropetrovsk Clinical Multidisciplinary Hospital for Psychiatric Care

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Malek Bajbouj

  lead OTHER

Principal Investigators

• Malek Bajbouj, Prof. Dr. med · Charité

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-22

Primary Completion

2027-02-28

Completion

2027-06-30

Countries

• Germany

Study Locations