Status:
COMPLETED
Hyperbaric Oxygen Therapy for Post Traumatic Stress Disorder
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Post Traumatic Stress Disorder
Eligibility:
MALE
25-60 years
Phase:
NA
Brief Summary
The study evaluates the effect of hyperbaric oxygen therapy on veterans with combat-associated PTSD in an double blind sham control study.
Detailed Description
Post-traumatic stress disorder (PTSD) is the brain's long-term imprint of a traumatic event. PTSD is characterized by intrusive thoughts, nightmares and flashbacks of past traumatic events, avoidance ...
Eligibility Criteria
Inclusion
- Subject willing and able to read, understand and sign an informed consent
- Age 25-60
- Five years or more after the last traumatic exposure
- CAPS-5 score PTSD symptoms questionnaire ≥ 20.
- Failure to improve after at least one line of conventional therapy, such as prolonged exposure, trauma related psychotherapy, eye movement desensitization therapy (EMDR).
- Stable psychological and pharmacological treatment for more than three months prior to inclusion.
Exclusion
- Inability to attend scheduled clinic visits and/or comply with the study protocol.
- History of TBI or any other brain pathology
- Active malignancy
- Substance use at baseline, except for prescribed cannabis if vaporized or taken PO as tincture
- Current manic episode or psychotic disorders
- Serious suicidal ideation
- Severe or unstable physical disorders or major cognitive deficits at baseline
- for any reason prior to study enrollment
- Chest pathology incompatible with pressure changes (including active asthma)
- Ear or Sinus pathology incompatible with pressure changes
- An inability to perform an awake brain MRI
- active smoking
Key Trial Info
Start Date :
February 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04518007
Start Date
February 25 2020
End Date
February 26 2024
Last Update
July 3 2024
Active Locations (1)
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1
Dialysis Clinic in Asaf Harofhe Medical Center
Ẕerifin, Israel, 70300