Comprehensive I-PASS implementation in a large academic medical centre necessitated major cultural change. I-PASS education is straightforward, whereas assuring consistent and sustained adoption across all services is more challenging, requiring adaptation of the basic I-PASS structure to local needs and workflows. EHR I-PASS templates facilitated caregiver acceptance. Initial phase I results are encouraging and the lessons learned should be helpful to other programmes planning handover initiatives. Phase II is ongoing, focusing on more uniform and consistent adoption, spread and sustainability.
Introduction: Mood and anxiety disorders are a prevalent and significant leading cause of years lived with a disability worldwide. Existing antidepressants drugs are only partially effective, having burdensome side effects. One-third of patients do not achieve remission after several adequate antidepressant trials, and relapses of depression are frequent. Psychotherapies for depression are limited by the lack of trained professionals, and further by out-of-pocket prohibitive costs. Existing FDA-approved, device-based interventions are either invasive or only administered in the office. Transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light may be a promising treatment option for mood and anxiety disorders. Due to its low cost, and ease of self-administration, t-PBM has the potential to become widely accessible. The safety profile of t-PBM is a relevant factor for widespread use and administration. Aim: To further investigate the t-PBM safety profile, this study aims to evaluate the tolerability and safety of t-PBM for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD). Method: We completed a systematic analysis of the side effects from repeated sessions of t-PBM in three studies: an open-label study for GAD (LIGHTEN GAD) and two randomized control studies for MDD (ELATED-2; ELATED-3). Overall, 80 subjects were studied. Result: Our results show that a low dose of NIR per t-PBM session can be administered with increasing frequency (up to daily sessions) and for several weeks (up to 12 weeks) without a corresponding increase in the occurrence or severity of adverse events. Additionally, there were no significant predictors for the variance in the number of reported adverse events (such as age, sex or diagnosis). Conclusion: The literature indicates that higher dosages of transcranial NIR could lead to greater antidepressant and anxiolytic effects; this study did not find any correlation between the increasing number of t-PBM sessions and the occurrence of adverse events.
Major depressive disorder (MDD) is a leading cause of disability worldwide with current FDA approved treatments often not providing sustained relief to patients. Transcranial photobiomodulation (tPBM) with near-infrared light (NIR) is a neuromodulation technique that affects mitochondrial metabolism and has shown beneficial clinical outcomes in neurological and psychiatric disorders. At the cellular level tPBM causes various effects including increased oxygen consumption, increased adenosinetriphosphate (ATP) production, and short bursts of reactive oxygen species (ROS). Decreasing oxidative stress through lowering the secondary production of ROS, and increasing neural connectivity, through boosting of neurogenesis and synaptogenesis, as well as increasing energy metabolism are putative mechanisms for tPBM antidepressant effect. Preliminary clinical trials have shown that NIR tPBM is effective at decreasing symptoms of depression compared to sham, however optimal dosimetry is still uncertain. In some reports, the antidepressant effects of tPBM were sustained after treatment discontinuation. Choice of adequate treatment parameters is likely critical to the efficacy and tolerability of tPBM for MDD. General conclusions can be drawn to guide clinicians to the off-label use of tPBM for MDD in clinical practice. [ Psychiatr Ann . 2022;52(11):466–471.]
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