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Background and Purpose: Hyperbaric oxygen therapy (HBOT) has been reported to improve neurological function in the chronic phase of stroke in a single trial having significant limitations, including a lack of a sham control., Methods: We conducted a single-center, parallel-group, randomized trial to determine the effectiveness of HBOT compared with a sham control in adults who were 6 to 36 months post-ischemic stroke. The treatment group received 40 sessions of HBOT at the Vancouver General Hospital Hyperbaric Unit. The control group received 40 sessions of sham treatment designed to replicate an HBOT experience. Due to recruitment challenges and timeline/feasibility tracking by the research team, the control arm was altered after 20 months to a waitlist in the hope of increasing participation. In the second phase, participants were randomized to receive HBOT immediately or following an eight-week observation period. The primary outcome was the post-treatment Stroke Impact Scale-16 (SIS-16). Secondary outcomes included the National Institute of Health Stroke Scale, Berg Balance Test, Digit Symbol Substitution Test, 5-Metre Walk Test, 6-Minute Walk Test, Grip Strength, Montreal Cognitive Assessment, Box/Block Test, and Center for Epidemiological Studies - Depression and Short Form-36. Based on detecting a clinically important between-group difference of 10 on the SIS-16 score, our target sample size was 68 participants per arm.  Results: From January 5, 2016 to October 9, 2018, 34 participants were enrolled in the trial, 27 during the first phase and seven in the second phase. The study was stopped after 36 months, and prior to meeting the sample size target, due to low recruitment. At the end of treatment, the difference in the SIS-16 between groups was 5 . 5 (95% CI: 1 . 3 to 9 . 7, p = 0 . 01) in favor of the sham group., Conclusions: Our results exclude a clinically important benefit of HBOT on the primary outcome of the SIS-16. These findings do not support the use of HBOT in chronic stroke survivors., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. University of British Columbia Clinical Research Ethics Board issued approval H15-00766. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Harrison et al.)

Introduction: Mental health problems frequently interfere with recovery from mild traumatic brain injury (mTBI) but are under-recognised and undertreated. Consistent implementation of clinical practice guidelines for proactive detection and treatment of mental health complications after mTBI will require evidence-based knowledge translation strategies. This study aims to determine if a guideline implementation tool can reduce the risk of mental health complications following mTBI. If effective, our guideline implementation tool could be readily scaled up and/or adapted to other healthcare settings., Methods and Analysis: We will conduct a triple-blind cluster randomised trial to evaluate a clinical practice guideline implementation tool designed to support proactive management of mental health complications after mTBI in primary care. We will recruit 535 adults (aged 18-69 years) with mTBI from six emergency departments and two urgent care centres in the Greater Vancouver Area, Canada. Upon enrolment at 2 weeks post-injury, they will complete mental health symptom screening tools and designate a general practitioner (GP) or primary care clinic where they plan to seek follow-up care. Primary care clinics will be randomised into one of two arms. In the guideline implementation tool arm, GPs will receive actionable mental health screening test results tailored to their patient and their patients will receive written education about mental health problems after mTBI and treatment options. In the usual care control arm, GPs and their patients will receive generic information about mTBI. Patient participants will complete outcome measures remotely at 2, 12 and 26 weeks post-injury. The primary outcome is rate of new or worsened mood, anxiety or trauma-related disorder on the Mini International Neuropsychiatric Interview at 26 weeks., Ethics and Dissemination: Study procedures were approved by the University of British Columbia's research ethics board (H20-00562). The primary report for the trial results will be published in a peer-reviewed journal. Our knowledge user team members (patients, GPs, policymakers) will co-create a plan for public dissemination., Trial Registration Number: ClinicalTrials.gov Registry (NCT04704037)., Competing Interests: Competing interests: NS has a private neuropsychological consulting practice and has received honoraria for providing continuing medical education. The other authors have no potential conflicts to declare., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)