Building Capacity and Healing: A First Nations-led Study of Education for Psychedelic-Assisted Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Nations Health and Social Secretariat of Manitoba

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Enhanced Curriculum

    Behavioral

    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 Curriculum

    Behavioral

    Standard online course delivered over two weekends with didactics, case seminars, supervision, and online modules. Delivered per TheraPsil schedule and documented for fidelity.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Enhanced CurriculumExperimental treatment 1 intervention
Group B: Standard CurriculumActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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

Secondary outcomes

1

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Nations Health and Social Secretariat of Manitoba

Lead sponsor

Accelerating Clinical Trials Consortium

Collaborator