An interventional study of Enhanced Curriculum and Standard Curriculum in Healthy, Healthcare Professional and Feasibility Studies, sponsored by First Nations Health and Social Secretariat of Manitoba. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by First Nations Health and Social Secretariat of Manitoba · Not applicable, Interventional, and Other
Building Capacity and Healing: A First Nations-Led Educational Pathway for Psychedelic-Assisted Therapy is an educational initiative led by the First Nations Health and Social Secretariat of Manitoba (FNHSSM). The goal of this clinical trial is to learn if a First Nations-led, culturally grounded education program for psychedelic-assisted therapy is feasible and acceptable by health practitioners working within First Nations communities. The main questions it aims to answer are:
Participants will acquire a full medicine bundle (spiritual, ethical, cultural, and scientific knowledge) through land-based teachings with respected Elders and Knowledge Keepers. No medicine administration occurs in this study.
Exclusion Criteria:
Control TheraPsil training PLUS an immersive First Nations-led educational program co-developed and delivered by First Nations Knowledge Holders.
Behavioral: Enhanced Curriculum
Virtual TheraPsil training package.
Behavioral: Standard Curriculum
The enhanced in-person and land-based educational curriculum includes: * Ceremony, cultural protocols and the "full medicine bundle" framework. * Knowledge on traditional medicines (tobacco, cedar, sage) and relational approaches to ceremonial medicines. * Ethical, trauma-informed, and relational practice. * Legal/regulatory framework overview contextualized for First Nations sovereignty. * Reflective circles and mentorship with Knowledge Keepers/Elders.
Standard online course delivered over two weekends with didactics, case seminars, supervision, and online modules. Delivered per TheraPsil schedule and documented for fidelity.
Feasibility of Recruiting Eligible Health Practitioners
This outcome will evaluate whether a First Nations-led educational program is feasible based on attaining a recruitment rate of 85% or higher within the first 4-weeks of recruiting eligible health practitioners.
Time frame: From recruitment start to 4-weeks enrollment.
Adherence to Intervention and Follow-up Assessments
The percentage of participants that complete the intervention and follow-up assessments.
Time frame: From baseline to final assessment (March 2027), approximately 5-months.
Acceptability of the Enhanced Curriculum
Whether participants respond positively to a standard training survey measured immediately after the in-person intervention.
Time frame: Immediately post-training
Self-Efficacy in Relation to Psychedelic-Assisted Therapy
Measured via a "Psychedelic-Assisted Therapy Attitudes and Culturally Centred Experiential Work Self-Efficacy Scale". This scale is a brief candidate measure developed for this feasibility trial to assess pre- to post-training changes in attitudes toward psychedelic-assisted therapy and self-efficacy in delivering or participating in culturally centred experiential work. The item set contains 16 items. Each item is phrased so that higher scores indicate stronger self-perceived confidence, readiness, or self-efficacy in relation to psychedelic-assisted therapy and culturally centred experiential work. This represents a feasibility measure related to our ability to collect the primary outcome of a larger trial, if feasible.
Time frame: Pre-training and immediately post-training for both intervention and control groups.
Plan to share: No — IPD will not be shared in adherence to First Nations principles of Ownership, Control, Access, and Possession (OCAP) and regional data sovereignty frameworks.
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