- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Taylor Morriseau, PhD
- Telefonnummer: 204-942-9400
- E-post: tmorriseau@fnhssm.com
Studieorter
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Manitoba
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Winnipeg, Manitoba, Kanada, R2C 5G1
- Rekrytering
- First Nations Health and Social Secretariat of Manitoba
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Kontakt:
- Donna Toulouse
- Telefonnummer: 204-946-9741
- E-post: dtoulouse@fnhssm.com
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility of Recruiting Eligible Health Practitioners
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Self-Efficacy in Relation to Psychedelic-Assisted Therapy
Tidsram: 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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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Wanda Phillips-Beck, PhD, First Nations Health and Social Secretariat of Manitoba
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2025-006
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