Trial-anchored psychedelic practice guidance

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

• Physiologic monitoring

  Monitors vital signs and physical status throughout dosing sessions and follow-up visits. Detects emerging medical problems early and escalates care when needed.

• Psychiatric risk monitoring

  Continuously assesses for anxiety, psychosis, suicidality, and other acute mental status changes. Uses de-escalation and emergency referral when indicated.

• Informed consent competence

  Conducts informed consent in a manner that ensures understanding of risks, procedures, and voluntariness. Verifies participant comprehension before enrollment.

Preview competencies (3)

• monitoring of mental state and risk

  Monitor participants for deterioration in mood, suicidality, mania, psychosis-like symptoms, or behavioral disturbance throughout the trial. The protocol uses repeated assessments, clinician review, and escalation pathways to protect safety.

• informed consent and participant autonomy

  Ensure participants understand the study, its risks, and their right to refuse or withdraw. Consent is required before screening procedures, recording, contact with significant others, and use of rescue or documentary footage where applicable.

• adverse event documentation and reporting

  Recognize, classify, and report adverse events according to trial and regulatory rules. The team must document expected and unexpected events, seriousness, causality, and timelines for reporting.

Preview competencies (3)

• Session monitoring and continuous observation

  Continuously observe the participant’s physical and mental status during dosing and respond to emerging concerns. At least one facilitator must remain present in the room throughout the session except for brief unavoidable breaks.

• Emergency recognition and escalation

  Recognize when a participant requires urgent medical or psychiatric intervention and activate emergency pathways. Facilitators, the PI, and the Study Physician must coordinate rapid response when needed.

• Suicide risk identification and response

  Screen for suicidality before, during, and after dosing and respond promptly to any escalation. Active suicidal ideation or suicidal behavior requires immediate clinical assessment and may preclude participation or continuation.

Preview competencies (3)

• therapeutic support during dosing

  The therapist provides continuous supportive presence during the approximately 6-hour dosing session. The role is to maintain a calm, supportive environment while the participant experiences acute effects.

• suicide risk monitoring

  The therapist/clinician must monitor suicidality throughout screening and follow-up using the C-SSRS and clinical judgment. Significant risk requires escalation and may preclude study entry or trigger urgent action.

• special-interest adverse event vigilance

  The protocol requires active monitoring for psychedelic-specific adverse events such as hallucinations, psychotic symptoms, dissociation, mood alteration, and cognitive disturbance. These require immediate notification and follow-up.

Preview competencies (3)

• Managing acute psychological reactions

  Monitors and responds to intense psychological effects that may occur during psilocybin sessions, such as anxiety, panic, paranoia, or altered insight. Prioritizes verbal and behavioral interventions, with escalation to rescue medication or medical support when needed.

• Suicidality assessment and response

  Performs repeated suicide risk monitoring across screening, dosing, integration, and follow-up visits. Knows how to escalate immediately if suicidality increases or becomes active.

• PAP treatment framework

  Understands the structure and rationale of psilocybin-assisted psychotherapy, including preparation, dosing, and integration phases. Knows how the psychotherapeutic context is intended to support symptom reduction and meaning-making.

Preview competencies (3)

• Suicidality assessment and response

  Assesses suicidal ideation and intent at multiple time points and initiates immediate escalation when risk is identified. Safety planning includes direct access to clinicians, emergency contacts, and psychiatric care.

• PAP preparation and integration psychotherapy

  Provides structured pre-dose preparation and post-dose integration to support therapeutic processing and meaning-making. The therapist helps participants develop rapport, clarify intentions, and consolidate insights after dosing.

• Psychedelic session support and presence

  Maintains continuous therapeutic presence during the dosing session to support the participant throughout altered states. The therapist responds to physical and emotional needs while preserving safety and containment.

Preview competencies (3)

• Psilocybin session facilitation

  Facilitate a prolonged high-dose psilocybin session in a structured, supportive environment. The facilitator supports inward focus, monitors the participant’s experience, and helps maintain therapeutic containment throughout the session.

• Cognitive-behavioral smoking cessation counseling

  Deliver structured CBT-based smoking cessation support throughout the trial. Facilitators teach practical self-management strategies before and after the target quit date.

• Post-session integration and processing

  Help participants integrate psilocybin session experiences into their smoking cessation efforts and broader life narrative. Integration is used to consolidate meaning, reinforce behavior change, and address concerns after dosing.

Preview competencies (3)

• Cardiovascular safety monitoring

  Monitor blood pressure carefully to reduce risk during screening and drug sessions. Repeated measurements and reassessment are required because transient or artifactual elevations may occur.

• Confidentiality and data protection

  Protect participant privacy and maintain confidentiality throughout screening and data handling. Study staff must minimize identifiable data access and use coded identifiers for all collected information.

• Pregnancy and reproductive risk screening

  Prevent fetal or nursing exposure to psilocybin by screening for pregnancy and enforcing contraception requirements. Female participants of child-bearing potential must be assessed before intake and before each session.

Preview competencies (3)

• Hallucinogen-assisted therapy preparation

  Provides structured pre-session preparation to establish a therapeutic mindset, rapport, and realistic expectations for psilocybin administration. Prepares participants to manage challenging experiences and clarifies the purpose and process of treatment sessions.

• Supportive non-directive session management

  Maintains a supportive, non-directive therapeutic stance during the dosing session while helping the participant remain safe and emotionally grounded. Uses brief check-ins and reassurance rather than interpretive or directive therapy during peak effects.

• Motivational interviewing and enhancement

  Uses motivational interviewing methods to strengthen intrinsic motivation and commitment to change. Tailors discussions to the participant’s ambivalence, goals, and readiness to change drinking behavior.

Preview competencies (3)

• In-session psychological support

  During psilocybin administration, facilitators provide continuous emotional support to help participants navigate acute effects. They use reassurance, grounding, and de-escalation to maintain safety and support the therapeutic process.

• Integration and meaning-making

  Facilitators lead post-dose integration sessions that help participants make sense of the experience and apply insights to daily life. Integration is described as a core best practice for psychedelic therapy.

• Participant monitoring during acute drug effects

  The facilitator must actively monitor participants during dosing for psychological and behavioral safety concerns. Monitoring includes observing distress, confusion, unsafe movement, and signs of emerging mania, psychosis, or suicidality.

Preview competencies (3)

• Supportive dosing-session facilitation

  During dosing, therapists provide a calm, structured supportive setting while minimizing active intervention. Their role is to maintain safety and help the patient navigate the experience without resistance.

• Management of challenging psychedelic experiences

  Therapists must recognize and respond to distress, anxiety, or intense experiences during the session. They should de-escalate while preserving safety and supporting the patient’s sense of control.

• Post-dose integration

  Therapists conduct integration sessions after each dose to help the participant process and integrate the acute experience. Integration is a core therapeutic task and may be used for training review if consented.

Preview competencies (3)

• Suicidality assessment and escalation

  Facilitators must identify warning signs of worsening mood or suicidality and initiate formal risk assessment promptly. They must know how to escalate concerns to the PI, psychiatrist, and emergency services when needed.

• Psychedelic-assisted therapy facilitation

  Facilitators must guide participants through preparation, psilocybin administration, and integration sessions in a structured group psychotherapy model. They are expected to maintain therapeutic presence, support meaning-making, and help participants process intense emotional and spiritual experiences.

• Emotional distress recognition and intervention

  Facilitators must detect and respond to emotional reactions such as fear, sadness, anxiety, paranoia, and ego dissolution during psilocybin sessions. They should intervene early with non-pharmacologic support and escalate when needed.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

• Manualized MDMA-assisted psychotherapy delivery

  Deliver psychotherapy according to the study manual with fidelity across preparatory, experimental, integrative, and follow-up phases. Therapists must adhere to standardized session structure while supporting the subject’s therapeutic process.

• Preparatory session facilitation

  Prepare subjects for MDMA-assisted psychotherapy by building rapport, setting expectations, and establishing safety and rules. Preparatory work is intended to support readiness, consent, and therapeutic alliance before drug sessions.

• Trauma processing and integration support

  Help the subject process traumatic material during and after MDMA sessions and integrate insights into daily life. Integration work focuses on emotional stabilization, meaning-making, and transfer of adaptive states beyond the session.

Preview competencies (3)

• Session monitoring and clinical observation

  Closely monitors physiological and psychological status throughout the experimental session and follow-up contacts. Adjusts the frequency of assessment based on clinical judgment and participant needs.

• Suicide risk assessment and management

  Assesses suicidality repeatedly and responds to changes in risk during all phases of the study. Ensures escalation and support when self-harm risk emerges.

• Crisis and emergency response

  Prepared to manage medical and psychiatric emergencies that may occur during the MDMA session or overnight stay. Coordinates on-site emergency resources and transfer to higher care when necessary.

Preview competencies (3)

• PTSD clinical assessment

  Understands the diagnostic and severity framework for PTSD and related symptom domains used in the protocol. Can support accurate identification of eligible participants and interpret symptom changes over time.

• Suicide risk assessment and response

  Can monitor suicide risk throughout the study and respond appropriately to escalating risk. This includes using C-SSRS, clinical judgment, escalation pathways, and emergency procedures.

• Medical complication monitoring during sessions

  Can monitor participants for acute medical complications related to MDMA, especially cardiovascular and neurologic concerns. Facilitators must recognize warning signs and escalate rapidly to medical staff.

Preview competencies (3)

• Continuous physiologic monitoring

  Clinical staff must monitor vital signs throughout the drug session and recognize abnormal trends that may require intervention or discontinuation. Monitoring is required every 30 minutes during drug visits.

• Emergency response and escalation

  Clinicians and coordinators must be prepared to implement protocol-specific emergency responses, call 911 when indicated, and initiate BLS/ACLS when needed. The framework includes explicit responses for myocardial infarction, desaturation, hypertension, arrhythmia, cardiac arrest, allergic reaction, nausea, and other emergencies.

• Informed consent facilitation

  Trained research staff must clearly explain the study, answer participant questions, and obtain written informed consent before enrollment. Consent includes explanation of randomization, study procedures, and optional saliva sampling with no effect on eligibility if declined.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

• Informed consent and capacity assessment

  Therapists/facilitators must ensure participants are cognitively able to understand the study and provide their own written informed consent. Consent must be obtained before any study-specific procedures and documented appropriately.

• Suicide risk monitoring

  Therapists/facilitators must monitor for suicidality throughout the study using validated tools and clinical observation. They must escalate concerns promptly and document findings accurately.

• Ethical conduct and respect for autonomy

  Facilitators must uphold ethical research principles, including participant autonomy, voluntariness, and the right to withdraw without penalty. They also must avoid coercive or noncompliant practices.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

• Informed consent facilitation

  The therapist/facilitator must ensure participants understand the study and voluntarily consent before any study procedures occur. Consent must be obtained in accordance with regulatory requirements and local IRB rules.

• Depression symptom monitoring

  The facilitator must monitor depressive symptoms closely across treatment and follow-up using standardized scales and clinical review. Response classification depends on these measurements.

• Suicide risk assessment and monitoring

  The facilitator must actively assess suicidality at each visit and respond to worsening risk immediately. Suicide-related events are specifically monitored as adverse events and serious adverse events.

Preview competencies (3)

• KAP psychotherapy delivery

  Deliver ketamine-assisted psychotherapy in a structured preparatory, dosing, and integration format. The therapist supports an initial non-directive experiential phase followed by directed processing and integration of session material.

• Suicide risk assessment and monitoring

  Identify and monitor suicidal ideation and other acute safety concerns before, during, and after treatment. The protocol requires structured C-SSRS use and immediate post-session safety checks.

• Informed consent process

  Ensure valid informed consent before any study procedures begin. The process requires clear explanation of risks, benefits, and study expectations, with signed documentation by the participant or legally authorized representative.

Preview competencies (3)

• Suicide risk screening and response

  Competence to identify participants at elevated suicide risk and respond with exclusion, urgent referral, or withdrawal from the study. Safety monitoring is emphasized before and throughout treatment.

• Physiologic monitoring during ketamine administration

  Skill in tracking vital signs and recognizing medically significant changes related to ketamine. The protocol requires monitoring blood pressure, pulse, respiration, temperature, and oxygenation before and after dosing.

• Informed consent interviewing

  Competence to obtain ethically valid informed consent by ensuring comprehension, voluntariness, and adequate opportunity for discussion. Only qualified study physicians or co-investigators may obtain consent in this protocol.

Preview competencies (3)

• Safety monitoring during ketamine dosing

  Facilitator must monitor participants for physiologic and psychological safety during and after ketamine administration. The protocol requires close observation and vital-sign monitoring.

• MORE delivery

  Facilitator can deliver Mindfulness-Oriented Recovery Enhancement (MORE) in an 8-week group format for patients with OUD. The intervention combines mindfulness training, cognitive reappraisal, and savoring techniques.

• Therapeutic support during acute distress

  Facilitator can offer supportive psychotherapeutic interventions during adverse psychological reactions. This includes responding to anxiety, dysphoria, paranoia, or agitation during treatment.

Preview competencies (3)

• Independent blinded rating

  Performs clinician-rated depression assessments in a blinded, independent manner to minimize bias. Maintains separation from other study assessments and treatment decisions for the same participant.

• Esketamine nasal administration

  Safely supervises self-administration of esketamine nasal spray according to dose, timing, and visit-order requirements. Ensures all procedural constraints are followed before, during, and after dosing.

• Quetiapine XR augmentation management

  Initiates, uptitrates, and monitors quetiapine XR augmentation in the comparator arm according to age-specific schedules and tolerability. Recognizes the therapeutic minimum and discontinuation triggers.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

Competency extraction pending.

Preview competencies (3)

• Qualified therapeutic presence during dosing

  Two trained study personnel must be present during dosing, and they must be able to support and monitor the patient throughout the acute experience. The lead monitor and assistant monitor require specific clinical qualifications and training relevant to psychedelic administration.

• Safety monitoring during dosing

  The facilitator must actively monitor physiological and psychiatric safety during dosing and after each dose. This includes frequent vital signs, oxygenation, sedation, dissociation, psychosis-like symptoms, and discharge readiness.

• Informed consent and patient preparation

  The therapist/facilitator must ensure informed consent is obtained before any protocol procedures and that the patient understands the dosing experience and trial expectations. Preparation includes explaining the procedure, expected psychoactive effects, and how to approach the experience without psychological resistance.