HYPERBARIC OXYGEN THERAPY FOR PTSD CLINICAL DEMONSTRATION PILOT

Sponsored by the Center for Compassionate Innovation, VHA Central Office

Department of Defense Site

SUMMARY

This clinical demonstration project proposes to provide Veterans, with a history of posttraumatic stress disorder (PTSD), with or without a diagnosis of co-occurring traumatic brain injury (TBI), access to hyperbaric oxygen therapy (HBOT). It is intended as a treatment option for a small group of Veterans who have not had success with at least two evidence based therapies. This project is a partnership with the Center for Compassionate Innovation (CCI), VA Northern California Health Care System (VAMC), and a Department of Defense (DoD) site: David Grant Medical Center (DGMC) located on the Travis Air Force Base, California.

PROGRAM AIM AND OBJECTIVES

This clinical demonstration project aims to help a small group of Veterans diagnosed with PTSD, with or without co-occurring TBI, who have not responded to traditional VA evidenced-based therapies for this disorder, to obtain access to HBOT through the Department of Veterans Affairs (VA). The primary purpose of this clinical demonstration is to offer help and hope in the form of an emerging treatment option to Veterans who continue to experience PTSD symptoms despite having tried multiple evidencebased therapies. This clinical demonstration project will include up to 100 Veterans referred to DGMC Hyperbaric Medicine Department located on the Travis Air Force Base to address neuropsychiatric symptoms.

BACKGROUND

At DGMC Hyperbaric Medicine Department, HBOT can be administered in one of two types of chambers, known as monoplace and multiplace chambers. Patients inside multiplace chambers breathe oxygen through a mask or hood. When treatments are conducted in a multi-place chamber, a qualified medical attendant is always present inside with the patient. It has been traditionally used to treat a limited number of conditions including decompression illness, non-healing wounds, necrotizing infections, certain ischemia, and the effects of radiation therapy. HBOT devices are considered class II medical devices by the U.S. Food and Drug Administration (FDA). The FDA considers these devices “safe and effective for their intended use.” HBOT is an intervention in which a patient breathes 100% medical grade oxygen, intermittently or continuously, inside a chamber that is pressurized to 1.5 to 2.0 atmospheres absolute (i.e., between 1.5 – 2.0 times higher than sea level pressure). The FDA considers the treatment of PTSD and TBI with HBOT as off-label use of the device.

Hyperbaric oxygen (HBO2) is currently being used to treat patients diagnosed with PTSD and TBI in at least 58 HBOT treatment centers located in 25 states throughout the U. S. In March 2017, the U. S. Marine Corps and the U. S. Navy, at Camp Lejeune, NC, authorized active duty service members to be treated by HBOT for PTSD and TBI. This treatment is being offered in conjunction with a research study being conducted by Dr. Paul Harch, the Department of Internal Medicine Director at Louisiana State University School of Medicine. Anecdotal1,2 reports and a limited amount of published research exist indicating that some Veterans with a history of PTSD and/or TBI show clinically significant improvement in their symptoms following HBOT. Additionally, a number of studies in the U. S. and in other countries have been completed or are ongoing and have focused on Veteran and non-Veteran participants with TBI and/or PTSD. Results from some studies also suggest promising results. Harch and colleagues3 analyzed results from a case study noting that the Veteran treated experienced significant improvement in TBI symptoms and resolution of PTSD symptoms after 39 HBOT sessions. Evoaldi and Zanetti4 treated a non-Veteran with head trauma and acute stress disorder with seven HBOT sessions noting significant improvement in neuropsychiatric symptoms. Harch and colleagues5 reported significant improvement in PTSD, TBI, depression, and anxiety symptoms; quality of life; and cognitive function, brain blood flow imaging, and reduced reliance of psychoactive and narcotic prescription medication. Research conducted by Eve and colleagues6 suggests that animal models indicate that HBOT may be valuable for treating both PTSD and TBI. Research conducted by Cifu and colleagues7 demonstrated significant reduction in some PTSD symptoms. This study was the impetus for the current clinical trial collaboration between the Department of Defense (DoD) and the VA focused on the use of HBOT for PTSD. Crawford and colleagues7 completed a review of the evidence literature and concluded that HBOT may be a reasonable and beneficial adjunctive therapy although additional research using better methodology is needed in order to clarify treatment efficacy.

REFERRAL PROCESS

VA clinician identifies Veteran based on clinical judgement, clinical indications described below, treatment history obtained through chart review, and patient agreement. PTSD diagnosis is confirmed by a mental health clinician.

Clinician discloses, in detail, the potential risks, benefits, designated location, and time commitment associated with this treatment option. Clinician informs Veteran that DGMC is participating in this project and that other HBOT clinics are not included as sites for this program evaluation. Veteran confirms with clinician that he or she is able and willing to commit to the full course of HBOT (up to 40 treatments).

Prior to submitting the consult, clinician confirms that Veteran has completed a PTSD Checklist for DSM-

5 (PCL-5) and Patient Health Questionnaire (PHQ-9) assessments within the last 30 days. If the PCL-5 and PHQ-9 have not been completed within the past 30 days, clinician administers these assessments using the templated forms available in the medical record software (Computerized Patient Record System – CPRS).

VA clinician collaborates with the Patient Aligned Care Team (PACT) to obtain medical clearance to undergo hyperbaric oxygen treatment. For example, ensuring female Veterans are not pregnant, Veterans with congestive heart failure have an echocardiogram with ejection fraction > 30%, or chest xray for Veterans with history of pulmonary disease.

VA clinician places a consult to DGMC for HBOT with a primary diagnosis of PTSD. Clinician should include, in the body of text on the referral, that at least two PTSD treatments have been attempted prior to referral for HBOT. Initial approval is for 40 HBO treatments with an expectation that the PCL-5 and PHQ-9 will be repeated at DGMC at completion of the 20th treatment and results forwarded to VAMC.

 DGMC clinician will be responsible for determining the optimal number of treatments up to 40.

Indications and Contraindications

Indications:
1. At the time of referral, Veteran meets diagnostic criteria for PTSD.
2. Stable mental health defined as negative for current or past psychotic illness, current mania, or current severe substance use disorder, and stable psychotropic medication history for at least two months.
3. Chart review includes documentation of Veteran participating in at least two different therapeutic modalities for their PTSD symptoms including psychotherapy, medication, or other therapeutic interventions. Veteran must continue to experience clinically significant PTSD symptoms (and TBI symptoms, if diagnosed).
4. Veteran must be able to commit to the HBOT treatment schedule with minimal or no missed treatment sessions. Veteran must be able to attend all pre- and post-treatment evaluations with the referring clinician including at least one follow-up visit within six weeks and at six months of final HBOT session (virtual or in-person).
5. Veteran must be willing and able to provide informed consent to receive the treatment without the aid of a proxy, caregiver, or guardian.
6. Veteran must be willing to receive and respond to communication from VA clinical staff monitoring the patient’s treatment progress as well as communication from DGMC regarding the use of HBOT and questions and comments about possible changes in PTSD and/or TBI symptoms.
7. Veteran must be at least 18 years of age.
Contraindications:
1. Active suicidal or homicidal ideation, substance use disorder, or recent history of severe agitation or aggression. Veterans will be referred to appropriate treatment clinicians for immediate intervention as indicated.
2. Co-existing psychiatric disorder that, in the judgement of the VA mental health clinician, would make it difficult for the patient to tolerate HBOT (e.g., active psychotic symptoms, mania). C. Does not possess capacity for medical decision-making at the time of the procedure. D. Standard medical contraindications for HBOT including those conditions listed below:
  1. History of seizure disorder
  2. History of spontaneous pneumothorax
  3. Uncontrolled allergic rhinitis or other sinus disease
  4. Pregnancy

Additional Considerations during referral process:

Clinician may consider administering additional measures available in routine VA clinical care, if deemed appropriate (e.g., Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), Beck Depression Inventory-II (BDI-II), Trauma History, Mini Interview for Mental Health Diagnoses, Outcome Questionnaire-45 (OQ45)). Should a Veteran experience mental health symptoms or need support from a mental health clinician, the Veteran will be referred appropriately.

Clinical Implementation of HBOT

As stated in the preceding referral process, if the Veteran meets the requirements for this HBOT clinical demonstration project, a consult is placed to DGMC.

Prior to the first treatment session, the DGMC staff will document the patient’s informed consent and will provide this documentation to the VA provider for entry into the patient’s medical record. The Veteran receives HBOT according to the treatment plan developed by the treatment site (DGMC). The treatment plan will be designed to achieve symptom improvement and is dependent on the total number of treatments identified by the clinic’s treatment protocol and the patient’s response to treatment. The number of treatment sessions will not exceed 40 per patient. No maintenance (aka “booster”) sessions of HBOT following the conclusion of the treatment protocol will be approved as part of this project. The DGMC provider will follow up with the referring VA clinician as necessary and when the patient reports any adverse reactions to treatment.

Within six weeks of the final HBOT, the VA clinician will conduct the post-treatment assessment. A follow up assessment will also be conducted at six months of final HBOT session to gauge long-term treatment outcomes. All assessments will be documented in CPRS.

CCI will follow up at intervals with the referring VA clinicians for status updates until the project is complete (funding has been exhausted/maximum number of patients have been scheduled).

Clinical Program Evaluation and Assessments:

Recommended clinical assessments for the Choice Provider to consider administering at treatment onset and at the conclusion of treatment numbers 15, 30, and 40:

PTSD Checklist for DSM-5 (PCL-5)

Patient Health Questionnaire (PHQ-9)

Program Evaluation

CCI staff will consult periodically with clinicians and/or the clinic director/coordinator to inquire about new consults and referrals; evaluate the project regarding the barriers and facilitators in the referral and treatment process; comments, recommendations, and suggestions about problems and concerns as well as what processes are efficient and easy to implement; necessary protocol deviations made to achieve success for the facility and referred patients; and suggestions about changes to the protocol that would improve the process.

Quarterly and at the conclusion of the clinical demonstration project, CCI staff will consult with DGMC to evaluate the project regarding the barriers and facilitators in the referral and treatment process; comments, recommendations, and suggestions about problems and concerns as well as what processes are efficient and easy to implement; necessary protocol deviations made to achieve success for the facility and referred patients; and suggestions about changes to the protocol that would improve the process.

Emergency Procedures

If the Veteran experiences an adverse reaction during the treatment session, DGMC will provide acute care, as necessary, at the time of the event and should contact the referring VA clinician to maintain continuity of care. DGMC, in collaboration with VAMC, will develop a plan for addressing potential mental health implications should the intervention fail to achieve the desired results. The VAMC will provide necessary medical care following an injury according to the Veteran’s eligibility.

1 https://nvf.org/ptsd-tbi-and-hbot/

2 http://treatnow.org/usmc-indiana-texas-oklahoma-making-hyperbaric-oxygen-therapy-hbot-available-service-members-tbiptsdconcussion/

3 Harch, P. G., Fogarty, E. F., Staab, P. K., & Van Meter, K. (2009). Low pressure hyperbaric oxygen therapy and SPECT brain imaging in the treatment of blastinduced chronic traumatic brain injury (post-concussion syndrome) and post traumatic stress disorder: a case report. Cases Journal, 2, 6538. http://doi.org/10.1186/1757-1626-0002-0000006538

4 Eovaldi, B., & Zanetti, C. (2010). Hyperbaric oxygen ameliorates worsening signs and symptoms of post-traumatic stress disorder. Neuropsychiatric Disease and Treatment, 6, 785–789. http://doi.org/10.2147/NDT.S16071

5 Paul G. Harch, Susan R. Andrews, Edward F. Fogarty, Daniel Amen, John C. Pezzullo, Juliette Lucarini, Claire Aubrey, Derek V. Taylor, Paul K. Staab, and Keith W.

Van Meter. A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and posttraumatic stress disorder. Journal of Neurotrauma. January 2012, 29(1): 168-185. https://doi.org/10.1089/neu.2011.1895

6 Eve, D. J., Steele, M. R., Sanberg, P. R., & Borlongan, C. V. (2016). Hyperbaric oxygen therapy as a potential treatment for post-traumatic stress disorder associated with traumatic brain injury. Neuropsychiatric Disease and Treatment, 12, 2689–2705. http://doi.org/10.2147/NDT.S110126 7 Cifu DX, Hart BB, West SL, Walker W, Carne W. The effect of hyperbaric oxygen on persistent postconcussion symptoms. J Head Trauma Rehabil. 2014;29(1):11– 20.

7 Crawford, C., Teo, L., Yang, E., Isbister, C., & Berry, K. (2017). Is Hyperbaric Oxygen Therapy Effective for Traumatic Brain Injury? A Rapid Evidence Assessment of the Literature and Recommendations for the Field. The Journal of Head Trauma Rehabilitation, 32(3), E27–E37. http://doi.org/10.1097/HTR.0000000000000256

Veterans with congestive heart failure have an echocardiogram with ejection fraction > 30%, or chest xray for Veterans with history of pulmonary disease.