- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Taylor Morriseau, PhD
- Numéro de téléphone: 204-942-9400
- E-mail: tmorriseau@fnhssm.com
Lieux d'étude
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Manitoba
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Winnipeg, Manitoba, Canada, R2C 5G1
- Recrutement
- First Nations Health and Social Secretariat of Manitoba
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Contact:
- Donna Toulouse
- Numéro de téléphone: 204-946-9741
- E-mail: dtoulouse@fnhssm.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Feasibility of Recruiting Eligible Health Practitioners
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Self-Efficacy in Relation to Psychedelic-Assisted Therapy
Délai: 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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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Wanda Phillips-Beck, PhD, First Nations Health and Social Secretariat of Manitoba
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2025-006
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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