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RecruitingNCT07806786Updated Sep 8, 2026

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy
  • Healthcare Professional
  • Feasibility Studies
  • Education Curriculum

Keywords

  • Psychedelic-Assisted Therapy
  • First Nations
  • Education
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.
  • Language proficiency: Proficiency in the language(s) used for the study (English or an Indigenous language if culturally appropriate) to ensure effective communication.
  • Stable health status: Participants should be in a relatively stable physical and mental health condition to ensure their ability to participate without compromising their well-being.
  • Access to support: Participants should have access to a support network or resources (e.g., counsellors, family, or community support) during the study to address any emotional or psychological distress that may arise.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Unwillingness to Engage: Individuals unwilling or unable to fully engage in study activities, such as interviews, focus groups, or educational pathways.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Enhanced Curriculum

    Control TheraPsil training PLUS an immersive First Nations-led educational program co-developed and delivered by First Nations Knowledge Holders.

    Behavioral: Enhanced Curriculum

  • Active comparator
    Standard Curriculum

    Virtual TheraPsil training package.

    Behavioral: Standard Curriculum

Interventions

  • BehavioralEnhanced 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.

  • BehavioralStandard Curriculum

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

05

What researchers measure

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.

06

Study locations

1 of 1 sites recruiting
  • First Nations Health and Social Secretariat of Manitoba
    Winnipeg, Manitoba R2C 5G1, Canada
    Recruiting
07

References and documents

Individual participant data

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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07806786
Lead sponsor
First Nations Health and Social Secretariat of Manitoba
Collaborators
Accelerating Clinical Trials Consortium
Responsible party
Sponsor
First posted
Sep 8, 2026
Start date
Sep 1, 2026
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Taylor Morriseau, PhD
Contact
tmorriseau@fnhssm.com
204-942-9400
Wanda Phillips-Beck, PhD
principal investigator · First Nations Health and Social Secretariat of Manitoba

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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