Trial-anchored psychedelic practice guidance

Preview competencies (0)

Competency extraction pending.

Preview competencies (0)

Competency extraction pending.

Preview competencies (3)

• Psychedelic pharmacology knowledge

  Understand the pharmacology, phenomenology, duration, and variability of DMT and harmine-assisted experiences. Recognize that harmine is a reversible monoamine oxidase inhibitor and that drug interactions, particularly with antidepressants and other medications, require careful assessment.

• Supportive therapeutic presence

  Maintain a calm, empathic, psychologically and physically available presence throughout the acute experience. Provide reassurance and support without imposing interpretations or directing the participant's inner process.

• Acute experience monitoring

  Continuously monitor the participant's subjective state and detect changes in intensity, fear, disliking, arousal, relaxation, loss of control, ambiguity, and ability to engage. Dynamic increases in intensity may signal greater psychological challenge.

Preview competencies (3)

• Clinical eligibility assessment

  Conduct a comprehensive psychiatric assessment to determine whether a participant meets clinical inclusion and exclusion criteria for psychedelic administration.

• Suicide-risk assessment

  Assess suicidality directly and repeatedly, recognizing that suicidal risk may exist independently of general depressive symptom severity.

• Participant preparation

  Prepare participants in advance by explaining likely experiences and practical strategies for responding to difficult or challenging psychological states.

Preview competencies (3)

• Participant screening and eligibility assessment

  Assess whether prospective participants meet clinical and safety criteria before psychedelic dosing. Screening should identify psychiatric, neurological, substance-use, medication, pregnancy, and prior psychedelic-exposure factors relevant to study eligibility.

• Psychedelic-session preparation

  Prepare participants for the acute dosing experience by explaining likely effects and providing practical strategies for managing anticipated difficulties. Preparation occurs in a comfortable clinical environment before dosing.

• Informed consent and respect for autonomy

  Ensure that participation is voluntary and based on adequate information about procedures, foreseeable effects, risks, and research status. The study required written informed consent before participation.

Preview competencies (1)

• ClinicalTrials.gov study record management knowledge

  Ability to understand and use ClinicalTrials.gov study record management resources and definitions when working with study information. This supports accurate interpretation of registration and results requirements.

Preview competencies (3)

• Clinical trial protocol literacy

  The facilitator should understand the study record context and be able to follow the trial-specific procedures described in the protocol. This includes awareness of how the study is registered and how information is managed in the trial record system.

• Regulatory compliance orientation

  The facilitator should operate within the administrative and regulatory framework governing clinical trial documentation. This involves respecting the rules that apply to study record managers and submitted information.

• Accurate data/record handling awareness

  The facilitator should be attentive to the requirements for submitting and managing study information accurately. This competency supports compliance with record-keeping expectations in a clinical trial setting.

Preview competencies (3)

• Clinical trial record navigation

  Ability to locate and use study-record information within ClinicalTrials.gov. This includes understanding where to find study details and related administrative information.

• Protocol and data element awareness

  Knowledge of study record management concepts relevant to registration and results reporting. A facilitator or therapist interacting with trial documentation should understand protocol-linked data fields and their definitions.

• Study documentation literacy

  General competency in interpreting clinical study documentation and administrative guidance. This supports accurate communication with study systems and research staff.

Preview competencies (3)

• Psychiatric screening and diagnostic assessment

  Conduct structured psychiatric screening and comprehensive diagnostic evaluation to determine whether candidates meet study eligibility requirements.

• Psychedelic preparation

  Provide a structured preparation session that establishes rapport, prepares participants for the DMT experience, and supports informed participation.

• Immediate psychological integration

  Facilitate structured integration shortly after dosing to support emotional processing, meaning-making, and connection of the experience with everyday life.

Preview competencies (3)

• Comprehensive clinical assessment

  Assess substance-use problems, mental and physical health, cognitive status, treatment history, motivation, life circumstances, and recovery goals before treatment entry.

• Set-and-setting management

  Prepare and maintain psychological, interpersonal, physical, cultural, and ritual conditions that support therapeutic benefit and reduce risk during altered states.

• Psychedelic-experience integration

  Help participants process, interpret, and apply ayahuasca, dieta, purging, and other altered-state experiences in ways that support recovery and everyday functioning.

Preview competencies (3)

• Meaning reconstruction therapy

  Deliver a structured grief intervention focused on helping bereaved participants reconstruct meaning following loss. Address disrupted meaning, adaptation, and post-traumatic growth within a coherent therapeutic framework.

• Participant screening and eligibility

  Apply inclusion and exclusion criteria and ensure that participants are appropriately screened before enrollment and psychedelic administration.

• Medical and physiological safety coordination

  Coordinate with medical personnel to assess physiological readiness and monitor participants before, during, and after ayahuasca administration.

Preview competencies (0)

Competency extraction pending.

Preview competencies (0)

Competency extraction pending.

Preview competencies (0)

Competency extraction pending.

Preview competencies (0)

Competency extraction pending.

Preview competencies (0)

Competency extraction pending.

Preview competencies (3)

• Integration interviewing

  Conduct post-treatment integration sessions that help participants describe and process their experience while preserving their authorship of its meaning.

• Qualified psychedelic therapy practice

  Practice as a qualified and specifically trained therapist or psychiatrist within a supervised psychedelic research team. Understand the responsibilities and limits of the therapist role in a clinical trial setting.

• Preparation and psychoeducation

  Prepare participants before dosing by explaining what to expect and how to respond to the psychedelic experience. Provide repeated preparation at screening, before admission, and immediately before dosing.

Preview competencies (3)

• Psychiatric symptom assessment

  Administer and interpret standardized psychiatric rating scales used in the study to evaluate depression, mania, psychosis-related symptoms, and dissociation. This supports both efficacy tracking and safety surveillance.

• Knowledge of ayahuasca pharmacology and effects

  Understand the basic pharmacology and clinical effects of ayahuasca to inform safe facilitation and interpretation of responses. The source identifies dimethyltryptamine as a 5-HT2A agonist and harmine as a monoamine-oxidase A inhibitor.

• Acute psychedelic effect monitoring

  Monitor participants closely during the acute effects of ayahuasca for psychoactivity, dissociation, and other mental status changes. Use structured assessments to track symptom intensity and detect emerging complications.

Preview competencies (3)

• Meaning reconstruction psychotherapy

  Ability to deliver a grief-focused psychotherapy grounded in meaning reconstruction theory. The therapist helps mourners work through the loss narrative, the relationship with the deceased, and the reconstruction of identity and future orientation.

• Narrative retelling of the loss

  Competence in non-directive narrative retelling to help participants revisit traumatic or stressful memories associated with the death. This supports coherent meaning-making while minimizing therapist imposition.

• Psychedelic preparation and expectation setting

  Competence in preparing participants for ayahuasca by building alliance, addressing uncertainties, and fostering an appropriate mindset and intention. Preparation is part of the safety and therapeutic framework for psychedelic-assisted therapy.

Preview competencies (3)

• Psychedelic-state support

  Provide expert support and guidance while participants undergo an acute DMT psychedelic experience. Maintain a calm, supportive presence throughout the anticipated period of intense perceptual, emotional, and cognitive alteration.

• Management of difficult emotional material

  Recognize and therapeutically contain difficult emotions and upsetting psychological content that may emerge during the psychedelic experience.

• Psychedelic phenomenology knowledge

  Understand the expected acute psychological effects and range of possible subjective experiences associated with DMT so that participant reports can be contextualized and supported.

Preview competencies (3)

• Psychedelic-assisted therapy expertise

  Possess substantial training and experience in psychedelic-assisted psychotherapy and understand the distinctive psychological, perceptual, emotional, and somatic effects of DMT-harmala medicines.

• Structured participant preparation

  Prepare participants through psychoeducation, expectation setting, procedural orientation, and review of practical and safety requirements before dosing.

• Informed consent and consent renewal

  Obtain and maintain informed, voluntary, and ongoing consent throughout preparation and treatment, including specific consent for therapeutic touch.

Preview competencies (3)

• Informed consent and ethics

  Obtain written informed consent and ensure the study is conducted under approved ethical oversight. Facilitators must follow human research ethics standards and protect participants throughout the intervention.

• Acute psychiatric monitoring

  Monitor for dissociation, psychotomimetic symptoms, and mania during the acute psychedelic phase. Repeated assessments were used to track tolerability and emerging adverse effects.

• Pre-session clinical assessment

  Conduct a full psychiatric and medical screening before dosing to determine eligibility and identify risks. This includes diagnostic evaluation, symptom severity assessment, and review of personal and family history relevant to psychedelic safety.

Preview competencies (3)

• Integrated addiction assessment

  Assess substance-use severity, treatment history, co-occurring mental health concerns, cognitive status, physical health, motivation, and life circumstances before and during treatment.

• Ceremony and retreat integration

  Support clients before, during, and after ceremonies, plant retreats, and other non-ordinary-state experiences, with emphasis on psychological meaning-making and everyday-life application.

• Contraindication and eligibility screening

  Identify individuals or circumstances for which participation may be inappropriate or unsafe, particularly in relation to ayahuasca and intensive residential treatment.

Preview competencies (3)

• Medical and psychiatric screening

  Assess participant suitability before psychedelic administration through structured medical and psychiatric screening. Identify contraindications and factors that may increase psychological or physiological risk.

• Informed consent and participant autonomy

  Obtain valid written informed consent and preserve participant autonomy throughout the intervention. Participants should understand procedures, risks, uncertainties, and their ability to decline or stop dosing.

• Continuous psychological observation

  Maintain direct, attentive observation throughout the acute intervention and identify changes in emotional state, cognition, behavior, and perceived control. A medically and psychologically trained investigator should remain present during the session.

Preview competencies (1)

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  The provided source text does not contain the guideline content needed to extract therapist/facilitator competencies. Access appears to be blocked by a browser verification page.

Preview competencies (3)

• Ethical evaluation transparency

  Maintains clear boundaries between clinical care, outcome evaluation, and research interpretation. Supports honest discussion of the strengths and limitations of the treatment protocol and evidence base.

• Treatment-setting design awareness

  Understands that the therapeutic setting is a central determinant of the design, delivery, and efficacy of ayahuasca-assisted addiction treatment. Can identify how environmental and programmatic features may influence outcomes.

• Qualitative clinical observation

  Uses qualitative methods to identify which aspects of the therapeutic setting are meaningful to clients and practitioners. This supports a deeper understanding of the treatment experience and its perceived impact.

Preview competencies (3)

• Integration facilitation

  Facilitate post-dose integration by helping participants reflect on the experience and translate insights into daily life. Integration was delivered in a participant-led, relational manner.

• Psychedelic session preparation

  Ability to prepare participants for a psychedelic dosing session through orientation, expectation-setting, and anxiety reduction. Preparation is structured to support relaxation, interpersonal safety, and emotional readiness.

• Set, setting, and environmental management

  Understand how preparation, setting, and context influence psychedelic treatment. Therapists must help create and maintain a supportive environment that reduces distress and promotes safety.

Preview competencies (3)

• Participant safety monitoring

  No specific therapist or facilitator safety-monitoring procedures are described in the provided source text. Any such competency cannot be extracted reliably from the excerpt alone.

• Protocol information interpretation

  Can distinguish between explicitly stated study information and information that is not provided in the registry excerpt. This is important for avoiding unsupported assumptions about therapist or facilitator duties.

• Clinical research documentation awareness

  Understands the importance of accurate data entry and compliance with registry data standards. This is an ethical responsibility in the context of study record management and reporting.

Preview competencies (1)

• Protocol and trial registration literacy

  The facilitator/therapist should understand the clinical trial context and how study information is represented in the registry. This includes familiarity with the study record and the data elements used for registration and results reporting.

Preview competencies (3)

• Psychedelic facilitation and support

  Provide in-session support during ayahuasca experiences in a way that protects physical and psychological safety while remaining non-directive. Facilitators must help participants engage with internal material openly as it emerges.

• Harm reduction and challenging-experience support

  Monitor and respond to challenging psychological reactions during ayahuasca sessions, including distress, panic, paranoia, and overwhelm. The facilitator should calm, ground, and if needed reposition the participant to a safer environment.

• Professional qualification and supervised practice

  Only appropriately trained licensed clinicians should deliver the psychotherapy component, and facilitators should work within their competence under supervision. The protocol emphasizes licensure, specialized training, and access to supervision.

Preview competencies (3)

• Psychiatric screening and eligibility assessment

  The facilitator must assess whether a participant is appropriate for ayahuasca administration by identifying inclusion factors and exclusion risks. This includes confirming recurrent major depressive disorder and screening for conditions that increase risk of adverse psychiatric reactions.

• Informed consent and participant education

  The therapist/facilitator must provide detailed information about the expected effects and risks of ayahuasca and ensure voluntary, informed participation. Consent should be documented in writing and obtained after adequate explanation.

• Symptom rating and clinical monitoring

  The facilitator should be able to administer standardized psychiatric scales repeatedly and interpret changes over time. This supports both safety monitoring and outcome assessment.

Preview competencies (3)

• Informed consent and risk disclosure

  The therapist/facilitator must provide clear, comprehensible information about the substance, expected psychological effects, and potential adverse effects before consent. Consent must be voluntary and documented.

• Standardized symptom rating administration

  The therapist/facilitator must competently administer repeated clinician-rated scales to track depressive, anxious, and manic symptoms over time. Training and clinical experience in these instruments are required.

• Pre-session medical screening

  The therapist/facilitator must ensure medical suitability before ayahuasca administration by checking for conditions that increase risk. Screening should include physical exam, laboratory testing, and pregnancy assessment when indicated.

Preview competencies (3)

• Pre-session psychiatric screening

  The facilitator must identify appropriate participants through structured psychiatric evaluation before dosing. This includes confirming diagnosis, treatment resistance, and screening for exclusionary psychiatric and medical risks.

• Eligibility and risk exclusion judgment

  Facilitators need competency in determining when a patient should not receive the intervention. The study excluded multiple psychiatric, medical, and substance-related risks to reduce harm and confounding.

• Monitoring acute psychological effects

  Facilitators must monitor for acute dissociation, psychosis-like symptoms, and mania during the session. The protocol used repeated standardized assessments to track these effects over time.

Preview competencies (1)

• Study record management literacy

  The therapist/facilitator should understand how study records are structured and managed within the ClinicalTrials.gov framework. This includes awareness of glossary terms and data element definitions used for registration and results reporting.

Preview competencies (1)

• Clinical trials record interpretation

  Understands how to read and extract information from a ClinicalTrials.gov study record. This includes recognizing that the provided source is a study listing rather than a clinical protocol or therapist manual.

Preview competencies (3)

• Clinical trial registration literacy

  Understands the basic structure and purpose of a ClinicalTrials.gov study record. Can locate and interpret study registration information relevant to the intervention context.

• Ethical use of trial information

  Uses publicly available trial information responsibly and within its intended scope. Respects that registry content is not a substitute for clinical judgment, consent procedures, or study-specific training.

• Study record data interpretation

  Can extract limited operational information from a study record and distinguish it from clinical or therapeutic guidance. This supports appropriate use of trial documentation in a therapy or facilitation setting.

Preview competencies (3)

• Safety monitoring during ayahuasca sessions

  Facilitators must continuously monitor physical and psychological safety during and after ayahuasca administration. This includes observing distress, checking vital signs, and responding to adverse effects promptly.

• Meaning reconstruction therapy delivery

  Therapists must competently deliver the 9-session meaning reconstruction protocol for grief, including its event story, back story, and personal story phases. The work is aimed at helping bereaved participants make sense of the loss, revise attachment-related meanings, and reconstruct identity and future orientation.

• Psychedelic integration support

  Therapists must help participants process and assimilate ayahuasca experiences after the session. Integration follows non-directive, restorative retelling principles to translate acute experiences into narrative and behavioral change.

Preview competencies (3)

• Integration interviewing

  Begin integration immediately after the psychedelic effects subside and use an interview-based process to help participants describe and reflect on their experience.

• Preparation and expectation setting

  Prepare participants for the psychedelic experience by explaining what to expect, discussing how to respond, and familiarizing them with the treatment environment and staff.

• Tolerability assessment

  Assess whether the participant tolerated the psychedelic experience and identify regret, distress, or other concerns during postdose integration.

Preview competencies (0)

Competency extraction pending.

Preview competencies (3)

• Non-interpretive integration

  Facilitators conduct immediate and next-day integration sessions that help participants describe and process the experience without imposing interpretations.

• Preparation and expectation setting

  Facilitators prepare participants for the psychedelic experience through repeated, structured sessions that explain what may occur and how participants may respond.

• Structured tolerability assessment

  Facilitators assess how the participant experienced and tolerated the session using open, non-leading inquiry and standardized ratings.

Preview competencies (3)

• Major depression trial eligibility screening

  Understands the participant population targeted by the study and can identify whether adults with major depressive disorder meet basic study criteria. This includes recognizing that the trial is for adults aged 21 to 65 whose depression has not improved with prescribed antidepressants.

• Psychedelic intervention awareness

  Understands that DMT is the investigational psychoactive compound being studied and has relevance to ayahuasca. Can describe the trial at a high level without overclaiming clinical benefit.

• Research study facilitation and referral

  Can support interested individuals by directing them to the appropriate study contact and volunteer pathways. This includes helping potential participants find the next step for enrollment or information requests.

Preview competencies (3)

• Monitoring anxiety and depression outcomes

  Able to assess and track changes in depression and anxiety over the course of treatment. This includes using standardized rating scales and interpreting symptom change pre- and post-treatment.

• Outcome interpretation in pilot research settings

  Understands that findings from a pilot evaluation support feasibility and preliminary effectiveness rather than definitive efficacy. The facilitator should interpret outcomes cautiously and support structured data collection.

• Knowledge of ayahuasca and traditional Amazonian medicine

  Understands the therapeutic role of ayahuasca as a psychoactive plant brew used ritually in traditional Amazonian medicine. Knowledge of the cultural and medicinal context is necessary to support safe and appropriate facilitation.

Preview competencies (3)

• Rigorous participant screening

  Conduct structured pre-screening and formal screening to identify exclusion criteria and reduce risk before experimental sessions. This includes building rapport, gathering key history, and referring suitable candidates for diagnostic evaluation.

• Supportive set-and-setting preparation

  Create a controlled, comfortable, and low-stimulus environment that supports psychological safety and reduces preventable distress. This includes anticipating both common and severe adverse scenarios before administration.

• Therapeutic presence and communication

  Maintain a calm, nonjudgmental, and non-directive interpersonal stance that supports the participant without shaping the experience. Communication should be simple, respectful, and focused on reassurance and safety.

Preview competencies (3)

• Continuous physical monitoring

  Participants must be continuously monitored to prevent avoidable hazards. The guide explicitly states that participants should never be left alone.

• Ayahuasca pharmacology knowledge

  Facilitators should understand the pharmacology of ayahuasca, including its composition and how it produces effects. This knowledge supports safer preparation, dosing, and risk explanation.

• Risk and contraindication screening

  Facilitators must know the risks and contraindications associated with ayahuasca use. They should identify medical and psychological factors that make participation unsafe or require extra caution.