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PTSD - Post Traumatic Stress DisorderAVRE-UNCT06806267

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

A study testing Virtual reality exposure therapy, transcranial direct current stimulation and Imaginal exposure therapy in people with PTSD - Post Traumatic Stress Disorder, run by Malek Bajbouj at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
PTSD - Post Traumatic Stress Disorder
What is being tested?
Virtual reality exposure therapy, transcranial direct current stimulation and Imaginal exposure therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteGermany
Study dates
22 Apr 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Age · The participant is 18 to 75 years of age, inclusive, at the time the informed consent form (ICF) is signed.
  • Type of Participant and Disease Characteristics:
  • 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.
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  • The participant has the ability to comply with study procedures.
  • The participant is fluent in Ukrainian and able to understand and comply with written and verbal protocol-related requirements.
  • The participant has received study inclusion approval through an adjudication process as to final suitability for the study.

Who cannot join

  • 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
  • Individuals with tinnitus
  • Medical Conditions
Show all 34Show fewer
  • It has been less than 6 months since the participant's index trauma event occurred, at the time of the Screening Visit.
  • The participant has current and ongoing exposure to the trauma that caused their PTSD.
  • The participant has complex PTSD, defined as a condition that may develop following exposure to an event or series of events of an extreme and prolonged or repetitive nature, which the participant experienced as extremely threatening or horrific and from which escape was difficult or impossible (e.g., torture, slavery, genocide campaigns, prolonged domestic violence, repeated childhood sexual or physical abuse). If affect dysregulation and interpersonal dysfunction are primary over other core PTSD symptoms, in the Investigator's opinion, participants should be excluded.
  • The participant has severe depression as measured by a score of ≥35 on the Montgomery-Åsberg Depression Rating Scale (MADRS) at the Screening Visit.
  • The participant has bipolar disorder, borderline personality disorder and other psychotic disorders as identified at the Screening Visit using the Structured Clinical Interview for DSM-5 Disorders - Clinical Trials Version (SCID-5-CT) and Personality Disorders (SCID-5-PD).
  • The participant has a history of moderate to severe traumatic brain injury.
  • The participant has a history of seizure disorders, uncontrolled sleep apnea or severe neurologic disease.
  • The participant has any moderate or severe substance use disorder according to DSM-5 in the 12 months prior to the Screening Visit.
  • The participant has a score of >15 points on the Alcohol Use Disorders Identification Test (AUDIT) at the Screening Visit.
  • The participant is at an increased risk of suicide, defined as:
  • Any suicide attempt in the 12 months prior to the Screening Visit disclosed by the participant using the Columbia Suicide Severity Rating Scale (C-SSRS)
  • Any suicidal ideation with intent (yes to item 4 and/or 5) in the past 6 months or suicidal behaviour in the past 12 months, as captured at the Screening Visit or Baseline Visit using the C-SSRS
  • A score >4 on item 10 of the MADRS at the Screening Visit.
  • The participant has a systolic blood pressure value >140 mmHg or diastolic blood pressure value >90 mmHg at the Screening Visit or Baseline Visit. Two repeat measures are allowed at the discretion of the Investigator.
  • The participant has negative experience or reaction to VR technology.
  • The participant has significant cognitive impairments affecting instruction comprehension.
  • The participant has any clinically significant ECG abnormality as determined by the Investigator at the Screening Visit.
  • The participant has pronounced adverse physiological reactions to VR that remain unmanageable
  • The participant is receiving concurrent trauma-based psychotherapy such as Cognitive Behaviour Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy.
  • Prior/Concomitant Therapy
  • The participant is receiving concurrent trauma-based psychotherapy such as Cognitive Behaviour Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy.
  • The participant has used marijuana or cannabinoid containing products daily (occasional use is allowed) for recreational use or self-medication (prescribed or otherwise) for the treatment of symptoms of PTSD or any other CNS disorder within 60 days of the Screening Visit.
  • Prior/Concurrent Clinical Study Experience
  • 1. The participant is currently enrolled in OR has previously participated in another investigational study in which an investigational medication (e.g., drug, vaccine, invasive device) was administered within 30 days before the ICF for this study is signed.
  • Other Exclusions
  • The participant is a member of the Ukrainian military currently serving on active duty.
  • The participant is in the process of litigating for compensation for a psychiatric disorder. Participants who are in the process of applying for medical or Veterans Affairs benefits and/or those who have settled a disability claim prior to enrolment in the trial are eligible.
  • The participant is not suitable to participate in the study, in the opinion of the investigator, because of clinically significant findings on medical history that could interfere with the objectives of the study or put the participant at risk or for any other reason the investigator deems applicable.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yuliya Kovalchuk, M.Sc. contact

+4915777013849

yuliya.kovalchuk@charite.de

Malek Bajbouj, Prof. Dr. med contact

malek.bajbouj@charite.de

Germany1 site, 1 recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

    Yuliya Kovalchuk, M.Sc., +4915777013849, yuliya.kovalchuk@charite.de

    Recruiting

Other trials in Germany

About this study

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

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?

Read more

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.

Read the 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.

Being tested
Virtual reality exposure therapy, transcranial direct current stimulation, Imaginal exposure therapy
Keywords
PTSD, VRET, tDCS, Virtual Reality, Exposure therapy, Veterans, Ukraine
Medical subject headings
Combat Disorders, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual reality exposure therapyDevice

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

  • transcranial direct current stimulationDevice

    transcranial direct current stimulation applied to the vmpfc, 2mA

  • Imaginal exposure therapyBehavioural

    Imaginal exposure therapy

Study groups in NCT06806267
Study groupRoleWhat they receive
VRETExperimentalParticipants will receive Virtual reality exposure therapy in addition to treatment as usual (pharmacotherapy)
Receives: Device: Virtual reality exposure therapy
VRET an tDCSExperimentalParticipants will receive Virtual reality exposure therapy and transcranial direct current stimulation in addition to treatment as usual (pharmacotherapy)
Receives: Device: Virtual reality exposure therapy; Device: transcranial direct current stimulation
Treatment as usualActive comparatorTreatment as usual. Participants will receive pharmacotherapy only
Receives: Behavioral: Imaginal exposure therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PTSD Symptoms

    CAPS-5 (Clinician-Administered PTSD Scale for DSM-5)

    • Minimum Value: 0
    • Maximum Value: 80
    • Higher Scores: Indicate worse outcomes, reflecting more severe PTSD symptoms.

    Measured: Before treatment until after treatment as well as 3-month and 6-month follow ups

  2. PTSD Symptoms as measured by PCL-5

    PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5)

    • Minimum Value: 0
    • Maximum Value: 80
    • Higher Scores: Indicate worse outcomes, as they reflect more severe PTSD symptoms.

    Measured: Before treatment until after treatment as well as 3-month and 6-month follow ups

Secondary outcomes (5)

  1. Symptoms of depression

    MADRS (Montgomery-Åsberg Depression Rating Scale)

    • Minimum Value: 0
    • Maximum Value: 60
    • Higher Scores: Indicate worse outcomes, reflecting more severe depression symptoms.

    Measured: Before and after end of treatment as well as at 3-month and 6-month follow ups

  2. Quality of life

    SF-36 (36-Item Short Form Health Survey)

    • Minimum Value: 0
    • Maximum Value: 100
    • Higher Scores: Indicate better outcomes, reflecting better health-related quality of life.

    Measured: Before and after end of treatment as well as at 3-month and 6-month follow ups

  3. Framework of acceptability Questionnaire

    Framework of acceptability Questionnaire

    • Minimum Value: 0
    • Maximum Value: 40
    • Higher Scores: Indicate better outcomes, reflecting higher levels of acceptability of the Intervention .

    Measured: Before and after end of treatment as well as at 3-month and 6-month follow ups

  4. Suicidal Ideation

    C-SSRS (Columbia-Suicide Severity Rating Scale)

    • Minimum Value: 0 (No suicidality)
    • Maximum Value: 25
    • Higher Scores: Indicate worse outcomes, reflecting increased severity of suicidal ideation or behavior.

    Measured: Before and after end of treatment as well as at 3-month and 6-month follow ups

  5. Anxiety

    GAD-7 (Generalized Anxiety Disorder-7)

    • Minimum Value: 0
    • Maximum Value: 21
    • Higher Scores: Indicate worse outcomes, reflecting higher levels of anxiety.

    Measured: Before and after end of treatment as well as at 3-month and 6-month follow ups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start22 Apr 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06806267
Sponsor's protocol ID
314159265358979323846264338
Acronym
AVRE-U
Status last verified
Aug 2026
First submitted
16 Jan 2025
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: to be decided

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality exposure therapy, transcranial direct current stimulation and Imaginal exposure therapy in people with PTSD - Post Traumatic Stress Disorder, run by Malek Bajbouj at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuliya Kovalchuk, M.Sc. (+4915777013849, yuliya.kovalchuk@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PTSD Symptoms (time frame: Before treatment until after treatment as well as 3-month and 6-month follow ups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06806267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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