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NCT Number: NCT07806786

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Nations Health and Social Secretariat of Manitoba

Winnipeg, Manitoba, R2C 5G1, Canada

Location status: Recruiting

Location contact

Donna Toulouse

CONTACT

[email protected]

204-946-9741

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Recruiting Eligible Health Practitioners

    Time frame: From recruitment start to 4-weeks enrollment.

    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.

  2. Adherence to Intervention and Follow-up Assessments

    Time frame: From baseline to final assessment (March 2027), approximately 5-months.

    The percentage of participants that complete the intervention and follow-up assessments.

  3. Acceptability of the Enhanced Curriculum

    Time frame: Immediately post-training

    Whether participants respond positively to a standard training survey measured immediately after the in-person intervention.

Secondary outcomes

  1. Self-Efficacy in Relation to Psychedelic-Assisted Therapy

    Time frame: Pre-training and immediately post-training for both intervention and control groups.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Taylor Morriseau, PhD

CONTACT

[email protected]

204-942-9400

Sponsors and collaborators

Lead sponsor

First Nations Health and Social Secretariat of Manitoba

Unknown

Collaborators

  • Accelerating Clinical Trials Consortium

Registry information

Official study title

Building Capacity and Healing: A First Nations-Led Educational Pathway for Psychedelic-Assisted Therapy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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