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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07806786
Enrollment
40
Registered
2026-09-08
Start date
2026-09-01
Completion date
2027-03-31
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Education Curriculum, Feasibility Studies, Healthcare Professional, Healthy

Keywords

Psychedelic-Assisted Therapy, First Nations, Education

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.

Interventions

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

Sponsors

First Nations Health and Social Secretariat of Manitoba
Lead SponsorOTHER
Accelerating Clinical Trials Consortium
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Recruiting Eligible Health PractitionersFrom 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.
Adherence to Intervention and Follow-up AssessmentsFrom baseline to final assessment (March 2027), approximately 5-months.The percentage of participants that complete the intervention and follow-up assessments.
Acceptability of the Enhanced CurriculumImmediately post-trainingWhether participants respond positively to a standard training survey measured immediately after the in-person intervention.

Secondary

MeasureTime frameDescription
Self-Efficacy in Relation to Psychedelic-Assisted TherapyPre-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.

Countries

Canada

Contacts

CONTACTTaylor Morriseau, PhD
tmorriseau@fnhssm.com204-942-9400
PRINCIPAL_INVESTIGATORWanda Phillips-Beck, PhD

First Nations Health and Social Secretariat of Manitoba

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026