HealthyNCT07806786
Building Capacity and Healing: A First Nations-led Study of Education for Psychedelic-Assisted Therapy
A study testing Enhanced Curriculum and Standard Curriculum in people with Healthy and Healthcare Professional, run by First Nations Health and Social Secretariat of Manitoba at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Healthcare Professional, Feasibility Studies
- What is being tested?
- Enhanced Curriculum and Standard Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
First Nations Health and Social Secretariat of Manitoba
Winnipeg, Manitoba, R2C 5G1
Donna Toulouse, 204-946-9741, dtoulouse@fnhssm.com
About this study
Official title: Building Capacity and Healing: A First Nations-Led Educational Pathway 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.
- Being tested
- Enhanced Curriculum, Standard Curriculum
- Keywords
- Psychedelic-Assisted Therapy, First Nations, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced CurriculumBehavioural
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 CurriculumBehavioural
Standard online course delivered over two weekends with didactics, case seminars, supervision, and online modules. Delivered per TheraPsil schedule and documented for fidelity.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Curriculum | Experimental | Control TheraPsil training PLUS an immersive First Nations-led educational program co-developed and delivered by First Nations Knowledge Holders. Receives: Behavioral: Enhanced Curriculum |
| Standard Curriculum | Active comparator | Virtual TheraPsil training package. Receives: Behavioral: Standard Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-training and immediately post-training for both intervention and control groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Sep 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Nations Health and Social Secretariat of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Accelerating Clinical Trials Consortium
- Responsible party
- Sponsor
- Investigators
- Wanda Phillips-Beck, PhD, Principal investigator, First Nations Health and Social Secretariat of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806786
- Sponsor's protocol ID
- 2025-006
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared in adherence to First Nations principles of Ownership, Control, Access, and Possession (OCAP) and regional data sovereignty frameworks.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Capacity and Healing: A First Nations-Led Educational Pathway for Psychedelic-Assisted Therapy
- ClinicalTrials.gov ID
- NCT07806786
- Acronym / sponsor ID
- 2025-006
- Keywords
- Psychedelic-Assisted Therapy, First Nations, Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Nations Health and Social Secretariat of ManitobaUniversity, hospital or other
- Collaborators
- Accelerating Clinical Trials Consortium
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Curriculum | Experimental | Behavioral: Enhanced CurriculumControl TheraPsil training PLUS an immersive First Nations-led educational program co-developed and delivered by First Nations Knowledge Holders. |
| Standard Curriculum | Active comparator | Behavioral: Standard CurriculumVirtual TheraPsil training package. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced CurriculumThe 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. | Behavioural | Enhanced Curriculum |
| Standard CurriculumStandard online course delivered over two weekends with didactics, case seminars, supervision, and online modules. Delivered per TheraPsil schedule and documented for fidelity. | Behavioural | Standard Curriculum |
Primary outcome
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.
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.
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.
1 secondary outcome
Self-Efficacy in Relation to Psychedelic-Assisted Therapy
Time frame: Pre-training and immediately post-training for both intervention and control groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be shared in adherence to First Nations principles of Ownership, Control, Access, and Possession (OCAP) and regional data sovereignty frameworks.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wanda Phillips-Beck, PhD principal investigator
First Nations Health and Social Secretariat of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Curriculum and Standard Curriculum in people with Healthy and Healthcare Professional, run by First Nations Health and Social Secretariat of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor Morriseau, PhD (204-942-9400, tmorriseau@fnhssm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Recruiting Eligible Health Practitioners (time frame: From recruitment start to 4-weeks enrollment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.