About this trial
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:
* Is a First Nations-led educational and culturally grounded intervention feasible in a land-based setting? * Do participants complete the intervention and follow-up assessments? * Does a First Nations-led program improve acceptability and knowledge comprehension of psychedelic-assisted therapy? Researchers will compare quantitative and qualitative data from those in the intervention who receive land-based training compared to virtual training modules to see if it improves acceptability, adherence, and knowledge comprehension.
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Experience working with or a member of an Indigenous population: Experience working with First Nations, Inuit, or Metis people in the capacity of a therapist, clinician, mental health practitioner, or community wellness worker.
Connection to community: Participants may reside, work within, or maintain significant connections with an Indigenous community (urban, rural, or on-reserve) to reflect the diversity of Indigenous contexts.
Age: Adults aged 18 and older to ensure participants can provide informed consent.
Availability to complete training and evaluation sessions: Participants must be available to complete both the required training components and the follow-up assessments, including participation in the First Nations-specific training if randomized to the intervention group.
Disqualifiers
Active Substance Use Disorder Without Stability: Individuals actively using substances in a way that would impede participation or pose safety concerns during study activities
Inability to Provide Informed Consent Individuals who cannot fully understand the study's purpose or consent process due to cognitive impairments or other reasons.
Lack of Community Connection: Individuals with no connection to or work with Indigenous communities, as this connection is integral to the study's cultural and contextual relevance.
Concurrent Participation in Conflicting Studies: Individuals participating in other research studies with similar goals or interventions in the last 12-months, to avoid conflicting influences or overburdening the participant.
Trial design
Parallel
Treatments tested in this trial
Enhanced Curriculum
BehavioralThe 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 Curriculum
BehavioralStandard online course delivered over two weekends with didactics, case seminars, supervision, and online modules. Delivered per TheraPsil schedule and documented for fidelity.
Treatment groups
Trial outcomes
Primary outcomes
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.
Adherence to Intervention and Follow-up Assessments
The percentage of participants that complete the intervention and follow-up assessments.
Acceptability of the Enhanced Curriculum
Whether participants respond positively to a standard training survey measured immediately after the in-person intervention.
Secondary outcomes
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.
Sponsors and contacts
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First Nations Health and Social Secretariat of Manitoba
Lead sponsor
Accelerating Clinical Trials Consortium
Collaborator