FIRST RESPONDER
CLINICAL TRIAL PARTNERSHIP 

About the Clinical Research


Gathering Groups is partnering with MAPS Canada and Empower Psychedelics toward a common commitment to contribute to the growing body of evidence of psychedelic-assisted therapies through the conduct of a clinical trial to address mental and physical health challenges and promote wellness.

As part of this partnership, Empower Psychedelics will conduct a clinical trial to assess the feasibility of a custom psilocybin-assisted group therapy program for first responders exploring potential effects on mental health, wellbeing, and cognition. MAPS Canada will support this project to raise funds that will go directly towards completing this impactful clinical trial.

The purpose of this Phase II clinical trial is to assess the feasibility of a custom, 12-week, group-based psilocybin-assisted therapy program, designed specifically for first responders (Advarra: Assessing the feasibility of a custom psychedelic-assisted group program on mental and physical health in firefighters Protocol PRo00066170). Secondary outcome measures will explore the impact of psilocybin-assisted group therapy on mental health, wellbeing, and cognition.

This trial will use a custom, group-based treatment protocol developed by Gathering Groups and will be administered by trained facilitators. The Gathering Groups model is based upon the learnings and successes of the Roots to Thrive Group Ketamine program adapted for psilocybin-assisted therapy. Based on the learnings, positive outcomes, increased accessibility and reduced cost of emerging group-based programs incorporating psychedelics, such as Roots to Thrive and Gathering Groups, it is believed group models may become a gold standard in the delivery of psychedelic-assisted therapies – particularly for first responders.

First Responder Study Population


This trial aims to enroll up to 36 first responders with diagnosed anxiety or depressive symptoms. Participants will be divided into subgroups of 6-8 who will undergo the therapy program together, either with a breathwork day (control) or an oral psilocybin dosing day at week 10. Trained facilitators will help create a trauma-informed space for the groups to thrive and promote cognitive resilience. The topics covered throughout the 12 weeks include breath-work, mindfulness, self compassion, embodiment, and Internal Family Systems work. Assessments will be completed for all participants at baseline, mid-program (week 6), end-of-program (week 12), and at a 6 month follow up to track changes throughout and beyond the program.

First responders respond to disasters and emergency situations that may be challenging, dangerous, and emotionally taxing. This is part of the reason that it is estimated that 30 percent of first responders will develop behavioral health conditions including, but not limited to, depression, anxiety, and post-traumatic stress disorder (PTSD). This is well above the average for the general population and in studies of suicidality, firefighters were reported as the highest in the category for attempt and ideation rates.

Additionally, the cultures of first responders often make it hard for this population to bring up their issues and to seek support. Models that break down barriers and reduce stigma are needed.

If you are a First Responder who is interested in joining this Clinical Trial, please fill out the form below to submit your inquiry to participate.

Empower Trial First Responder Waitlist Form
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