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

NCT07806786 | Recruiting

• 1 other identifier: 2025-006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Healthcare Professional; Feasibility Studies; Education Curriculum

Keywords

Psychedelic-Assisted Therapy; First Nations; Education

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Immediately post-training

Secondary Outcomes (1)

• Self-Efficacy in Relation to Psychedelic-Assisted Therapy

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

Study Arms (2)

Enhanced Curriculum

EXPERIMENTAL

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

Behavioral: Enhanced Curriculum

Standard Curriculum

ACTIVE COMPARATOR

Virtual TheraPsil training package.

Behavioral: Standard Curriculum

Interventions

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.

Enhanced Curriculum

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.

Standard Curriculum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Nations Health and Social Secretariat of Manitoba: lead
• Accelerating Clinical Trials Consortium: collaborator

Study Sites (1)

First Nations Health and Social Secretariat of Manitoba

Winnipeg, Manitoba, R2C 5G1, Canada

RECRUITING

Study Officials

• Wanda Phillips-Beck, PhD

  First Nations Health and Social Secretariat of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylor Morriseau, PhD

CONTACT

204-942-9400; tmorriseau@fnhssm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)