跳至主要内容
临床试验/NCT07806786
NCT07806786招募中不适用

Building Capacity and Healing: A First Nations-Led Educational Pathway for Psychedelic-Assisted Therapy

First Nations Health and Social Secretariat of Manitoba1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Feasibility of Recruiting Eligible Health Practitioners

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Enhanced Curriculum

Experimental

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

干预措施: Enhanced Curriculum (Behavioral)

Standard Curriculum

Active Comparator

Virtual TheraPsil training package.

干预措施: Standard Curriculum (Behavioral)

结局指标

主要结局

Feasibility of Recruiting Eligible Health Practitioners

时间窗: From recruitment start to 4-weeks enrollment.

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.

Adherence to Intervention and Follow-up Assessments

时间窗: From baseline to final assessment (March 2027), approximately 5-months.

The percentage of participants that complete the intervention and follow-up assessments.

Acceptability of the Enhanced Curriculum

时间窗: Immediately post-training

Whether participants respond positively to a standard training survey measured immediately after the in-person intervention.

次要结局

  • Self-Efficacy in Relation to Psychedelic-Assisted Therapy(Pre-training and immediately post-training for both intervention and control groups.)

研究者

发起方
First Nations Health and Social Secretariat of Manitoba
申办方类型
Other
责任方
Sponsor

研究点 (1)

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