Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-02 @ 9:32 AM
Study NCT ID:
NCT06806267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effectiveness of VRET Combined With tDCS in the Treatment of PTSD in Ukrainian Veterans and Civilians
Sponsor:
Malek Bajbouj
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVRE-U
Brief 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.
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.
Detailed Description:
This research initiative, supported by Charité - Universitätsmedizin Berlin, involves collaboration among six Ukrainian institutions to investigate the effectiveness of Virtual Reality Exposure Therapy (VRET) combined with Transcranial Direct Current Stimulation (tDCS) for the treatment of PTSD in war veterans and civilians.
Background and Rationale
Reports since 2015 indicate that approximately 27.7% of individuals involved in the Anti-Terrorist Operation (ATO) in Ukraine have been diagnosed with PTSD, highlighting a critical need for innovative treatments.
Exposure therapy is a well-established treatment for PTSD, helping individuals process traumatic memories through techniques such as gradual exposure and arousal control. However, traditional approaches often result in high dropout rates due to the emotional intensity required. Virtual Reality Exposure Therapy (VRET) offers a promising alternative by providing immersive, interactive, and controlled environments that facilitate emotional processing and reduce avoidance behaviors. A culturally adapted Ukrainian version of the VRET protocol, developed in 2024 at the Bogomolets National Medical University, has shown potential for addressing trauma-specific needs in Ukrainian PTSD patients.
tDCS is a non-invasive neuromodulation technique that applies low electrical currents to the scalp to influence brain activity. It has shown promise in alleviating PTSD-related symptoms such as anxiety, depression, and emotional dysregulation. Combining tDCS with VRET may enhance treatment outcomes by leveraging neuroplasticity to improve emotional regulation and cognitive processing.
This study aims to validate a culturally adapted VRET protocol for PTSD treatment in Ukraine and evaluate whether combining it with tDCS further enhances therapeutic outcomes.
Treatment Protocols
Virtual Reality Exposure Therapy (VRET)
The VRET protocol involves ten 60-minute sessions structured in two phases:
* Phase 1: Screening, informed consent, and baseline assessments.
* Phase 2 (Sessions 1-10): Gradual exposure to trauma-related virtual environments with guided psychological interventions, including psychoeducation, relaxation techniques, and cognitive restructuring. Sessions are tailored to individual needs with real-time adjustments by therapists.
Session Highlights:
* Session 1: Psychoeducation about PTSD and relaxation training.
* Sessions 3-5: Gradual introduction of tailored VR scenarios with controlled activation of traumatic memories.
* Sessions 6-9: Narrative construction of traumatic experiences, with continued relaxation and emotional regulation techniques.
* Session 10: Assessment of emotional state and development of self-stabilization skills for daily life.
tDCS-Augmented VRET (tDCS-VRET) The tDCS-VRET protocol incorporates tDCS during VRET sessions to enhance neuromodulation. Sessions are identical to the VRET protocol, with the addition of tDCS targeting the dorsolateral prefrontal cortex.
* tDCS Parameters: 2 mA current, with 30-second ramp-up and ramp-down phases, not exceeding 30 minutes per session.
* Sessions include tDCS alongside VR exposure scenarios, relaxation techniques, and physiological monitoring to reinforce adaptive coping.
Technical Specifications
* VRET Equipment: Oculus Quest 2 headset with Unity3D-based VR software by "VR Mentality" LLC, enabling real-time therapist adjustments and personalized trauma-related scenarios.
* tDCS Equipment: NeuroFlow device with app-controlled interface, silicone electrodes, and 2 mA current capacity.
Objectives
* Assess the effectiveness of culturally adapted VRET for PTSD in Ukrainian patients.
* Evaluate the added benefit of tDCS in enhancing VRET outcomes, including reductions in PTSD symptoms, anxiety, and depression, and improvements in emotional regulation and quality of life.
This protocol offers an innovative and integrative approach to PTSD treatment by combining state-of-the-art virtual reality technology with neuromodulation to address the specific needs of Ukrainian trauma survivors.
Background and Rationale
Reports since 2015 indicate that approximately 27.7% of individuals involved in the Anti-Terrorist Operation (ATO) in Ukraine have been diagnosed with PTSD, highlighting a critical need for innovative treatments.
Exposure therapy is a well-established treatment for PTSD, helping individuals process traumatic memories through techniques such as gradual exposure and arousal control. However, traditional approaches often result in high dropout rates due to the emotional intensity required. Virtual Reality Exposure Therapy (VRET) offers a promising alternative by providing immersive, interactive, and controlled environments that facilitate emotional processing and reduce avoidance behaviors. A culturally adapted Ukrainian version of the VRET protocol, developed in 2024 at the Bogomolets National Medical University, has shown potential for addressing trauma-specific needs in Ukrainian PTSD patients.
tDCS is a non-invasive neuromodulation technique that applies low electrical currents to the scalp to influence brain activity. It has shown promise in alleviating PTSD-related symptoms such as anxiety, depression, and emotional dysregulation. Combining tDCS with VRET may enhance treatment outcomes by leveraging neuroplasticity to improve emotional regulation and cognitive processing.
This study aims to validate a culturally adapted VRET protocol for PTSD treatment in Ukraine and evaluate whether combining it with tDCS further enhances therapeutic outcomes.
Treatment Protocols
Virtual Reality Exposure Therapy (VRET)
The VRET protocol involves ten 60-minute sessions structured in two phases:
* Phase 1: Screening, informed consent, and baseline assessments.
* Phase 2 (Sessions 1-10): Gradual exposure to trauma-related virtual environments with guided psychological interventions, including psychoeducation, relaxation techniques, and cognitive restructuring. Sessions are tailored to individual needs with real-time adjustments by therapists.
Session Highlights:
* Session 1: Psychoeducation about PTSD and relaxation training.
* Sessions 3-5: Gradual introduction of tailored VR scenarios with controlled activation of traumatic memories.
* Sessions 6-9: Narrative construction of traumatic experiences, with continued relaxation and emotional regulation techniques.
* Session 10: Assessment of emotional state and development of self-stabilization skills for daily life.
tDCS-Augmented VRET (tDCS-VRET) The tDCS-VRET protocol incorporates tDCS during VRET sessions to enhance neuromodulation. Sessions are identical to the VRET protocol, with the addition of tDCS targeting the dorsolateral prefrontal cortex.
* tDCS Parameters: 2 mA current, with 30-second ramp-up and ramp-down phases, not exceeding 30 minutes per session.
* Sessions include tDCS alongside VR exposure scenarios, relaxation techniques, and physiological monitoring to reinforce adaptive coping.
Technical Specifications
* VRET Equipment: Oculus Quest 2 headset with Unity3D-based VR software by "VR Mentality" LLC, enabling real-time therapist adjustments and personalized trauma-related scenarios.
* tDCS Equipment: NeuroFlow device with app-controlled interface, silicone electrodes, and 2 mA current capacity.
Objectives
* Assess the effectiveness of culturally adapted VRET for PTSD in Ukrainian patients.
* Evaluate the added benefit of tDCS in enhancing VRET outcomes, including reductions in PTSD symptoms, anxiety, and depression, and improvements in emotional regulation and quality of life.
This protocol offers an innovative and integrative approach to PTSD treatment by combining state-of-the-art virtual reality technology with neuromodulation to address the specific needs of Ukrainian trauma survivors.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: