[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655055":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":34,"interventions":47,"overallOfficials":55,"centralContacts":59,"locations":65,"responsibleParty":84,"collaborators":86,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":26,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":26,"enrollmentInfo":99,"targetDuration":26,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":111,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"First Nations Health and Social Secretariat of Manitoba","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":26},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Feasibility of Recruiting Eligible Health Practitioners","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.","From recruitment start to 4-weeks enrollment.",{"measure":14,"description":15,"timeFrame":16},"Adherence to Intervention and Follow-up Assessments","The percentage of participants that complete the intervention and follow-up assessments.","From baseline to final assessment (March 2027), approximately 5-months.",{"measure":18,"description":19,"timeFrame":20},"Acceptability of the Enhanced Curriculum","Whether participants respond positively to a standard training survey measured immediately after the in-person intervention.","Immediately post-training",[22],{"measure":23,"description":24,"timeFrame":25},"Self-Efficacy in Relation to Psychedelic-Assisted Therapy","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.","Pre-training and immediately post-training for both intervention and control groups.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":6,"observationalModel":26,"timePerspective":26,"maskingInfo":30},"RANDOMIZED","PARALLEL",{"masking":31,"maskingDescription":26,"whoMasked":32},"SINGLE",[33],"OUTCOMES_ASSESSOR",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Enhanced Curriculum","EXPERIMENTAL","Control TheraPsil training PLUS an immersive First Nations-led educational program co-developed and delivered by First Nations Knowledge Holders.",[40],"Behavioral: Enhanced Curriculum",{"label":42,"type":43,"description":44,"interventionNames":45},"Standard Curriculum","ACTIVE_COMPARATOR","Virtual TheraPsil training package.",[46],"Behavioral: Standard Curriculum",[48,52],{"type":49,"name":36,"description":50,"armGroupLabels":51,"otherNames":26},"BEHAVIORAL","The enhanced in-person and land-based educational curriculum includes:\n\n* Ceremony, cultural protocols and the \"full medicine bundle\" framework.\n* Knowledge on traditional medicines (tobacco, cedar, sage) and relational approaches to ceremonial medicines.\n* Ethical, trauma-informed, and relational practice.\n* Legal\u002Fregulatory framework overview contextualized for First Nations sovereignty.\n* Reflective circles and mentorship with Knowledge Keepers\u002FElders.",[36],{"type":49,"name":42,"description":53,"armGroupLabels":54,"otherNames":26},"Standard online course delivered over two weekends with didactics, case seminars, supervision, and online modules. Delivered per TheraPsil schedule and documented for fidelity.",[42],[56],{"name":57,"affiliation":5,"role":58},"Wanda Phillips-Beck, PhD","PRINCIPAL_INVESTIGATOR",[60],{"name":61,"role":62,"phone":63,"phoneExt":26,"email":64},"Taylor Morriseau, PhD","CONTACT","204-942-9400","tmorriseau@fnhssm.com",[66],{"facility":5,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"RECRUITING","Winnipeg","Manitoba","R2C 5G1","Canada","CA",{"type":74,"coordinates":75},"Point",[76,77],-97.14704,49.8844,{"lat":77,"lon":76},[80],{"name":81,"role":62,"phone":82,"phoneExt":26,"email":83},"Donna Toulouse","204-946-9741","dtoulouse@fnhssm.com",{"type":85,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[87],{"name":88,"class":6},"Accelerating Clinical Trials Consortium","100655055","building-capacity-and-healing-a-first-nations-led-study-of-education-for-psychedelic-assisted-therapy-100655055",false,"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","Inclusion Criteria:\n\n* 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.\n* 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.\n* Age: Adults aged 18 and older to ensure participants can provide informed consent.\n* 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.\n* Language proficiency: Proficiency in the language(s) used for the study (English or an Indigenous language if culturally appropriate) to ensure effective communication.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Active Substance Use Disorder Without Stability: Individuals actively using substances in a way that would impede participation or pose safety concerns during study activities\n* Inability to Provide Informed Consent Individuals who cannot fully understand the study's purpose or consent process due to cognitive impairments or other reasons.\n* 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.\n* 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.\n* Unwillingness to Engage: Individuals unwilling or unable to fully engage in study activities, such as interviews, focus groups, or educational pathways.",true,"ALL","18 Years",{"count":100,"type":101},40,"ESTIMATED","INTERVENTIONAL",[104],"NA","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:\n\n* Is a First Nations-led educational and culturally grounded intervention feasible in a land-based setting?\n* Do participants complete the intervention and follow-up assessments?\n* 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.\n\nParticipants 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.",[107,108,109,110],"Healthy","Healthcare Professional","Feasibility Studies","Education Curriculum",[112,113,114],"Psychedelic-Assisted Therapy","First Nations","Education","2026-09-01",{"date":117,"type":118},"2026-09-08","ACTUAL",{"date":115,"type":118},{"date":121,"type":101},"2027-03-31",{"name":5,"class":6},1]