Study of the Effectiveness of VRET Combined With tDCS in the Treatment of PTSD in Ukrainian Veterans and Civilians
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMalek Bajbouj
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Virtual reality exposure therapy
DeviceExposure therapy applied through virtual reality goggles, controlled by a clinician
transcranial direct current stimulation
Devicetranscranial direct current stimulation applied to the vmpfc, 2mA
Imaginal exposure therapy
BehavioralImaginal exposure therapy
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: VRETExperimental treatment 1 intervention
Group B: VRET an tDCSExperimental treatment 2 interventions
Group C: Treatment as usualActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Before treatment until after treatment as well as 3-month and 6-month follow ups2
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.
Time frame
Before treatment until after treatment as well as 3-month and 6-month follow upsSecondary outcomes
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.
Time frame
Before and after end of treatment as well as at 3-month and 6-month follow ups2
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.
Time frame
Before and after end of treatment as well as at 3-month and 6-month follow ups3
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 .
Time frame
Before and after end of treatment as well as at 3-month and 6-month follow ups4
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.
Time frame
Before and after end of treatment as well as at 3-month and 6-month follow upsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov