- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Taylor Morriseau, PhD
- Telefonnummer: 204-942-9400
- E-post: tmorriseau@fnhssm.com
Studiesteder
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Manitoba
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Winnipeg, Manitoba, Canada, R2C 5G1
- Rekruttering
- First Nations Health and Social Secretariat of Manitoba
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Ta kontakt med:
- Donna Toulouse
- Telefonnummer: 204-946-9741
- E-post: dtoulouse@fnhssm.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Enhanced Curriculum
Control TheraPsil training PLUS an immersive First Nations-led educational program co-developed and delivered by First Nations Knowledge Holders.
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The enhanced in-person and land-based educational curriculum includes:
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Aktiv komparator: Standard Curriculum
Virtual TheraPsil training package.
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Standard online course delivered over two weekends with didactics, case seminars, supervision, and online modules.
Delivered per TheraPsil schedule and documented for fidelity.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of Recruiting Eligible Health Practitioners
Tidsramme: From recruitment start to 4-weeks enrollment.
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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.
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From recruitment start to 4-weeks enrollment.
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Adherence to Intervention and Follow-up Assessments
Tidsramme: From baseline to final assessment (March 2027), approximately 5-months.
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The percentage of participants that complete the intervention and follow-up assessments.
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From baseline to final assessment (March 2027), approximately 5-months.
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Acceptability of the Enhanced Curriculum
Tidsramme: Immediately post-training
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Whether participants respond positively to a standard training survey measured immediately after the in-person intervention.
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Immediately post-training
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Self-Efficacy in Relation to Psychedelic-Assisted Therapy
Tidsramme: Pre-training and immediately post-training for both intervention and control groups.
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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.
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Pre-training and immediately post-training for both intervention and control groups.
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Wanda Phillips-Beck, PhD, First Nations Health and Social Secretariat of Manitoba
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2025-006
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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