None listed
Conditions
Brief summary
Aims This pilot study aims to assess the feasibility, acceptability, and safety of delivering 60 sessions of hyperbaric oxygen therapy (HBOT) at two differing pressures to ex-serving members of the ADF diagnosed with post-traumatic stress disorder (PTSD), while exploring preliminary effects on brain function (fMRI) and psychological outcomes. This will generate effect size estimates and refine the design and methodology of a future large-scale randomised controlled trial. 2 hypotheses are: 1. It is hypothesized, based on the current available research, that HBOT is effective in treating ex-serving members of the ADF diagnosed with PTSD, providing long term changes. 2. Different levels of ATA and total oxygen dose will affect the degree of symptomatic improvements.
Interventions
This is an intervention, pilot study looking at the efficacy of hyperbaric oxygen therapy in treating Ex-Serving Members of the Australian Defence Force Diagnosed With Post-Traumatic Stress Disorder, comparing two different pressures 1.5 ATA and 2 ATA.
The participants will be randomly selected into one of two groups: one group completing 60 sessions of 90 minute durations of hyperbaric oxygen therapy (HBOT), 5 days a week for 12 weeks at 2 atmospheres (ATA) of pressure or 1.5 ATA. This will be
This is an intervention, pilot study looking at the efficacy of hyperbaric oxygen therapy in treating Ex-Serving Members of the Australian Defence Force Diagnosed With Post-Traumatic Stress Disorder, comparing two different pressures 1.5 ATA and 2 ATA. The participants will be randomly selected into one of two groups: one group completing 60 sessions of 90 minute durations of hyperbaric oxygen therapy (HBOT), 5 days a week for 12 weeks at 2 atmospheres (ATA) of pressure or 1.5 ATA. This will be conducted at a speciaist hyperbaric clinic on the Gold Coast. The intervention will be delivered by trained/qualified nurses and hyperbaric technicians. They will be required to complete questionnaires prior to the first session around PTSD symptoms, sleep and heart rate variability, after the 30th session, after the last HBOT session and three months after the intervention as a follow up. Resting state functional MRIs (rsfMRI) will be undertaken before the 1st HBOT session, after the 30th and after the 60th session. These will take place at Mermaid Beach Radiology clinic and will take around 30 minutes. Adherence to the HBOT intervention will be assessed using prospective session attendance logs. Attendance will be recorded for all scheduled sessions (total n = 60 per participant), including completion status and reasons for missed or incomplete sessions where available. Adherence will be defined a priori as the proportion of prescribed sessions completed per participant. Intervention fidelity will be ensured through the use of a standardised treatment protocol, including fixed pressure allocation (1.5 ATA or 2.0 ATA), session duration (90 minutes), oxygen delivery parameters, and air break schedules. These parameters will be pre-set and recorded each session. Operator-completed session checklists will be used to confirm protocol delivery, including verification of participant identity, prescribed pressure, session duration, completion of air breaks, and documentation of any deviations or adverse events. Strategies to support adherence will include appointment reminders (e.g., SMS/email) and flexible scheduling where feasible. Reasons for non-adherence or withdrawal will be recorded to inform feasibility outcomes.
Sponsors
Bond University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
• Ex-Serving Members of the Australian Defence Force Diagnosed With Post-Traumatic Stress Disorder by the subject’s healthcare practitioner using the Clinician-Administered PTSD Scale (CAPS) or similar. The questionnaire has 30 questions and includes both the diagnostic criteria for PTSD as well as questions about the severity and frequency of symptoms. • Between the ages of 25-60 • Women and men
Exclusion criteria
• Unstable medical conditions, such as a serious brain injury, serious heart condition, pneumothorax (to be screened with chest X-ray), neurological disorder, cancer or seizure disorder • Currently pregnant or lactating • Have current substance abuse • Previous HBOT treatment • Ear or sinus pathologies incompatible with pressure changes such as severe sinusitis, pharyngitis or otitis media • No planned major surgical procedures planned during the timeframe of the study • cognitive impairment, an intellectual disability, or a mental illness
Outcome results
None listed