- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Taylor Morriseau, PhD
- Número de teléfono: 204-942-9400
- Correo electrónico: tmorriseau@fnhssm.com
Ubicaciones de estudio
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Manitoba
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Winnipeg, Manitoba, Canadá, R2C 5G1
- Reclutamiento
- First Nations Health and Social Secretariat of Manitoba
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Contacto:
- Donna Toulouse
- Número de teléfono: 204-946-9741
- Correo electrónico: dtoulouse@fnhssm.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of Recruiting Eligible Health Practitioners
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-Efficacy in Relation to Psychedelic-Assisted Therapy
Periodo de tiempo: 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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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Wanda Phillips-Beck, PhD, First Nations Health and Social Secretariat of Manitoba
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2025-006
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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