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

NCT06806267 | Recruiting

• 1 other identifier: 314159265358979323846264338
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

PTSD; VRET; tDCS; Virtual Reality; Exposure therapy; Veterans; Ukraine

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (5)

• Symptoms of depression

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

• Quality of life

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

• Framework of acceptability Questionnaire

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

• Suicidal Ideation

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

• Anxiety

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

Study Arms (3)

VRET

EXPERIMENTAL

Participants will receive Virtual reality exposure therapy

Device: Virtual reality exposure therapy

VRET an tDCS

EXPERIMENTAL

Participants will receive Virtual reality exposure therapy and transcranial direct current stimulation

Device: Virtual reality exposure therapy; Device: transcranial direct current stimulation

Treatment as usual

ACTIVE COMPARATOR

Participants will receive non-virtual reality exposure therapy

Behavioral: Imaginal exposure therapy

Interventions

Virtual reality exposure therapy DEVICE

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

VRET; VRET an tDCS

transcranial direct current stimulation DEVICE

transcranial direct current stimulation applied to the vmpfc, 2mA

VRET an tDCS

Imaginal exposure therapy BEHAVIORAL

Imaginal exposure therapy

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Malek Bajbouj: lead
• 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

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Interventions

Transcranial Direct Current Stimulation; Implosive Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Desensitization, Psychologic; Behavior Therapy; Psychotherapy

Study Officials

• Malek Bajbouj, Prof. Dr. med

  Charité

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuliya Kovalchuk, M.Sc.

CONTACT

+4915777013849; yuliya.kovalchuk@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 4, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)