Health Research Ethics Board of Alberta Approves ATMA's Phase II Psilocybin Clinical Trial with Group and Individual Therapy Settings

This trial will assess the efficacy of psilocybin-assisted therapy in treating mental healthcare professionals suffering from Major Depressive Disorder, in group and individual dosing sessions, commencing Q3 2024.

CALGARY, AB, May 22, 2024 /PRNewswire/ - ATMA Journey Centers Inc. ("ATMA"), a pioneering Canadian company with a primary focus on advancing innovative psychedelic-assisted therapy solutions, has received approvals for its Phase II Psilocybin-assisted Therapy Clinical Trial from the Health Research Ethics Board of Alberta (HREBA) and Health Canada (No Objection Letter). The primary objective of this trial will be to evaluate the potential of psilocybin-assisted therapy in treating frontline mental healthcare professionals diagnosed with Major Depressive Disorder (MDD), administered in either a group or individual setting.

While a considerable portion of the Canadian population continues to struggle with mental distress stemming from the repercussions of COVID-19, healthcare professionals themselves have faced significant mental hurdles. Indeed, despite the immense physical and psychological burdens imposed by the pandemic – both direct and indirect – many mental healthcare professionals have prioritized the well-being of their patients over their own, resulting in an unaddressed need for mental support; healthcare professionals, like the general population, experience psychological trauma leading to mental health challenges. However, evidence suggests that these challenges are more prevalent among frontline workers due to the nature of their work. From compassion fatigue to vicarious traumatization, these workers often do not use effective coping mechanisms to navigate their depression while continuing their professional duties. Consequently, many have inadvertently normalized chronic depression.

As such, the primary objective of this study is to examine the efficacy of psilocybin-assisted therapy in treating frontline mental healthcare workers diagnosed with MDD. This will be accomplished by comparing the scores on standardized self-assessment questionnaires administered to participants before and after their psilocybin session. The secondary exploratory objective of this study is to investigate the effect psilocybin has on personal and professional characteristics that enhance competency as a mental healthcare worker, as well as participants' self-assessment of their competency and confidence in administering psilocybin-assisted therapy.

Additionally, in collaboration with experts in psychedelic group therapy such as Dr. Mark Atkinson of Human Potential Academy and Dr. Simon Ruffell of Onaya Science, ATMA is exploring a novel protocol for this Phase II trial. This sub-group analysis aims to investigate the potential efficacy of psilocybin-assisted therapy through both group and individual administration frameworks. Based on research exploring the potential benefits of group therapy for addressing depression, ATMA's protocol offers options for either individual sessions or a group setting. The group therapy hypothesis suggests that the group approach may foster social connectedness and well-being by inducing states of communitas and facilitating psychological safety, potentially promoting empathy, cooperation, and aiding in psychological integration and self-regulation. Plans are in motion to prepare for future Phase III trials with a focus on refining the group therapy design. Furthermore, although the primary goal of these trials is not necessarily to improve accessibility to psilocybin, there is a possibility that these trials could enhance affordability and accessibility, possibly alleviating the financial burden on both the healthcare system and participants.

Considering the size and nationwide scope of this trial, ATMA has partnered with KGK Science to ensure successful execution. KGK is an experienced clinical research company specializing in product development. With preparations underway for Canada's largest Phase II clinical trial on psilocybin-assisted therapy, this initiative will encompass three sites nationwide, including the ATMA CENA Psychedelic Therapy Clinics in Calgary, AB and London, ON, along with Qi Integrated Health in Vancouver, BC.

The trial will be open to frontline mental healthcare professionals who have completed an approved psychedelic-assisted therapy training program; this includes the 750+ ATMA alumni and others who have equivalent training and meet the other eligibility requirements.  ATMA believes that training in psychedelic therapy as well as a thorough understanding of psychedelic medicines are crucial for participants in this trial. Such training equips participants with the necessary knowledge and skills to navigate the psychedelic experience safely and effectively. It enables them to understand the potential effects of psilocybin on their mental health and well-being, and how to integrate these experiences into their therapeutic journey, which will provide the field with valuable data in terms of the secondary exploratory objective.

Graduates of ATMA's Advanced Psychedelic Therapy Training Program – predominantly qualified therapists with psychedelic-assisted therapy training and facilitating experience – will be offered the opportunity to contribute to ATMA's Phase II and III clinical trial therapist staffing needs, amounting to up to 6,000 hours. ATMA's training program has equipped hundreds of therapists and healthcare practitioners for this role, offering a valuable chance for those interested in the psychedelic-assisted therapy field to gain more experience in this field as clinical trial staff facilitators and therapists.

CEO Vu Tran emphasizes the potential of the group protocol as a pivotal advancement for the psychedelic therapy industry, not only by enhancing accessibility, but also by validating the effectiveness of group healing practices rooted in non-Western and ancient cultures. He highlights the epidemic of loneliness as a contributing factor to the current mental health crisis and advocates for embracing group healing formats as a means of addressing this challenge.

We care about improving the lives and practices of mental healthcare professionals.

ATMA is pioneering a healthcare practitioner-centered business model for the psychedelic industry. By providing education, training, clinical trials leading to IP protocols, support services, and developing a network of clinics, we are building and supporting a vast community of psychedelic practitioners in adopting psychedelic-assisted therapy and thereby improving access for many.

SOURCE ATMA Journey Centers Inc