Recruiting

Psychedelic-Assisted Therapy

Sponsor:

First Nations Health and Social Secretariat of Manitoba

Code:

NCT07806786

Conditions

Healthy

Healthcare Professional

Feasibility Studies

Education Curriculum

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Enhanced Curriculum

Standard Curriculum

Study Details

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

Study ID

NCT07806786

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Enhanced Curriculum

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

active comparator: Standard Curriculum

Virtual TheraPsil training package.

Interventions

Enhanced 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.

Standard Curriculum

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

Primary outcome measure

  • Feasibility of Recruiting Eligible Health Practitioners [ Time Frame: From recruitment start to 4-weeks enrollment. ]
  • Adherence to Intervention and Follow-up Assessments [ Time Frame: From baseline to final assessment (March 2027), approximately 5-months. ]
  • Acceptability of the Enhanced Curriculum [ Time Frame: Immediately post-training ]

Central Contacts and Locations

Central contacts

Taylor Morriseau, PhD

204-942-9400tmorriseau@fnhssm.com

Locations

First Nations Health and Social Secretariat of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R2C 5G1

Contacts

Donna Toulouse

204-946-9741dtoulouse@fnhssm.com

More Information

Sponsor

First Nations Health and Social Secretariat of Manitoba

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Psychedelic-Assisted Therapy
  • First Nations
  • Education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by First Nations Health and Social Secretariat of Manitoba on 2026-09-08.