trial protocol paperEvidence score: 90
Psilocybin-Assisted Massed Cognitive Processing Therapy for Chronic Posttraumatic Stress Disorder: Protocol for an Open-Label Pilot Feasibility Trial
Attribution: Meshkat et al., 2025
Source guideline: Open link
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Psilocybin session facilitation
Facilitate the 6- to 8-hour psilocybin dosing session in a controlled, supportive environment. Provide continuous availability and remain with the participant until acute effects have subsided.
Non-directive psychedelic support
Use a supportive, minimally interpretive approach during the acute psychedelic state. Be directive only when necessary to maintain safety and avoid active coaching or imposing interpretations.
Psychological and physical safety monitoring
Monitor participants before, during, and after psilocybin administration for physiological effects, psychological distress, medical events, adverse reactions, and suicidality. Escalate concerns to the study physician or emergency services as required.
14 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Protocol: Psilocybin-Assisted Group Therapy for Demoralization in Long-Term AIDS Survivors
Attribution: Anderson et al., 2020
Source guideline: Open link
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Licensed clinical practice
Facilitators should be licensed clinicians or appropriately supervised trainees with sufficient clinical exposure. They must be approved by the study's clinical oversight panel and authorized by the institutional review process.
Supportive-Expressive Group Therapy fidelity
Group therapists must competently deliver the modified, manualized Brief Supportive-Expressive Group Therapy model while adapting it appropriately to psilocybin-assisted treatment and the needs of people living with HIV.
Group leadership and co-facilitation
Facilitators must be able to lead structured psychotherapy groups collaboratively and manage the interpersonal processes that support cohesion and therapeutic change.
15 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Development of a Psychotherapeutic Model for Psilocybin-Assisted Treatment of Alcoholism
Attribution: Bogenschutz and Forcehimes, 2017
Source guideline: Open link
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Acute safety and physiological monitoring
Monitor psychological and physiological status throughout medication sessions and recognize when medical or psychiatric intervention is required.
Post-session discharge and continuity safety
Verify safety before discharge and arrange appropriate supervision and follow-up after medication administration.
Psychedelic experience debriefing
Use open-ended inquiry to help participants describe and reflect on the medication session, including its emotional, personal, relational, spiritual, and behavioral significance.
14 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Psilocybin-Assisted Therapy for Treatment-Resistant Depression: PsiDeR Trial Protocol
Attribution: Rosenblat et al., 2021
Source guideline: Open link
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Competency extraction pending.
trial protocol paperEvidence score: 90
Comparative acute effects of mescaline, lysergic acid diethylamide, and psilocybin: trial protocol and supervised-session methods
Attribution: Ley et al., 2023
Source guideline: Open link
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Competency extraction pending.
trial protocol paperEvidence score: 90
Comparative Acute Effects of LSD, Psilocybin and Mescaline: LPM Study Protocol and Registry Record
Attribution: Ley et al., 2023
Source guideline: Open link
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Competency extraction pending.
trial protocol paperEvidence score: 90
Psilocybin-Assisted Therapy for Reducing Alcohol Intake in Patients with Alcohol Use Disorder: QUANTUM Trip Trial Protocol
Attribution: Henderson et al., 2022
Source guideline: Open link
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Competency extraction pending.
trial protocol paperEvidence score: 90
Protocol: Psilocybin-Assisted Therapy for Treatment-Resistant Obsessive–Compulsive Disorder
Attribution: Zai et al., 2023
Source guideline: Open link
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Professional qualification and supervised practice
Lead therapists must hold appropriate licensure and regulatory registration to provide psychotherapy, and have prior PAP experience. Unlicensed or inexperienced therapists may participate only under direct supervision.
Psilocybin-assisted psychotherapy delivery
Therapists must be able to deliver preparatory, dosing-session support, and integration components of psilocybin-assisted psychotherapy within the study protocol. This includes creating a therapeutic alliance, orienting participants to the psychedelic experience, and supporting meaning-making afterward.
Continuous observation during dosing
A core facilitator safety function is ongoing monitoring during the acute psilocybin session. Therapists must observe participants continuously for adverse events and changes in emotional or physical status.
16 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Protocol: A Phase 1/2 Study of a Group Model of Psilocybin-Assisted Therapy for Cancer-Related Anxiety in Patients with Metastatic Cancer
Attribution: Back et al., 2024
Source guideline: Open link
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Suicide and serious psychiatric risk assessment
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.
General psychedelic-assisted practice skills
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.
15 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Study Protocol and Statistical Analysis Plan: A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence
Attribution: O'Donnell et al., 2022
Source guideline: Open link
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General psychedelic-assisted practice skills
Monitors vital signs and physical status throughout dosing sessions and follow-up visits. Detects emerging medical problems early and escalates care when needed.
Acute psychiatric and behavioral 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.
23 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Study Protocol and Statistical Analysis Plan: Effects of Psilocybin in Major Depressive Disorder
Attribution: Davis et al., 2020
Source guideline: Open link
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Build rapport and psychological safety
Develop a trusting therapeutic relationship before dosing to reduce fear and anxiety and support safe participation.
Monitor acute psychological effects
Systematically observe and document behavioral, emotional, and subjective effects during and after psilocybin administration.
Monitor physiological safety
Follow protocol-defined physiological monitoring procedures and recognize when medical support is required.
15 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Protocol for a Double-Blind, Randomized, Placebo-Controlled Phase II Trial of Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder
Attribution: Vanderijst et al., 2024
Source guideline: Open link
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Clinical qualifications and experience
Therapists should have appropriate graduate-level training and clinical experience with psychiatric patients. The lead therapist requires a related master's degree and at least three years of clinical experience; the co-therapist requires equivalent graduate training or advanced study.
Protocol and manual fidelity
Therapists must understand and consistently implement the study manual and standardized psychotherapeutic intervention. They are required to read the full manual, complete study-specific training, and participate in supervision.
Acceptance and commitment therapy
Therapists apply key ACT principles as the psychotherapeutic framework for psilocybin-assisted therapy. The aim is to increase psychological flexibility and support values-based behavioral change.
21 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Protocol for Psilocybin versus Escitalopram for Depression
Attribution: Carhart-Harris et al., 2021
Source guideline: Open link
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Competency extraction pending.
trial protocol paperEvidence score: 90
Study Number COMP 001 – Psilocybin for Treatment-Resistant Depression: Clinical Trial Protocol
Attribution: COMPASS Pathfinder, 2018
Source guideline: Open link
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Suicide risk assessment and escalation
Therapists/facilitators must be able to recognize, assess, and escalate suicidal ideation and behavior throughout the study. Positive responses on the C-SSRS require investigator review and may trigger referral, AE/SAE reporting, or study ineligibility.
Good Clinical Practice and protocol adherence
Therapists/facilitators working in the study must conduct care and research activities in accordance with the approved protocol, GCP, applicable regulations, and ethical principles for human research. They are expected to understand protocol requirements and ensure supervised staff are informed.
Preparatory psychoeducation
Therapists/facilitators must be able to provide structured preparatory sessions before dosing. Preparation focuses on expectations, review of psychoeducational materials, and orienting the participant to the psilocybin session.
18 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Interpersonal Therapy Plus Psilocybin Manual for Treatment-Resistant Depression
Attribution: Lacey et al., 2022
Source guideline: Open link
trial protocol paperEvidence score: 90
Study Protocol: Persisting Effects of Psilocybin
Attribution: Johns Hopkins University, 2019
Source guideline: Open link
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General psychedelic-assisted practice skills
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.
Screening, eligibility, and readiness assessment
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.
16 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Clinical Research Protocol: Group Psilocybin-Assisted Therapy
Attribution: Back et al., 2022
Source guideline: Open link
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Acute psychological response and emergency management during dosing
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.
Psychedelic-assisted psychotherapy preparation and integration
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.
15 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Clinical Research Protocol: Psilocybin-Assisted Psychotherapy for Depression
Attribution: Yale University, 2024
Source guideline: Open link
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Psilocybin-assisted psychotherapy facilitation
Facilitates preparation, dosing-day support, and integration therapy for participants receiving psilocybin, using a manualized PAP approach. This includes helping establish therapeutic alliance, set intentions, and support meaning-making after the dosing session.
Professional licensure and supervision
Therapists must meet licensure requirements and work within supervision structures appropriate to their training and role. Unlicensed or PAP-inexperienced staff require direct supervision.
Challenging experience support and grounding
Supports participants through acute psychological and sensory changes during the psilocybin experience while maintaining a psychologically safe environment. Therapists are expected to normalize, contain, and help participants navigate difficult states.
19 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Clinical Research Protocol: Psilocybin for Treatment-Resistant Depression Without Psychedelic Effects
Attribution: Raison et al., 2023
Source guideline: Open link
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Manualized psilocybin-assisted therapy delivery
Deliver protocol-based psychotherapy across preparatory, dosing-day, and integration sessions using the study’s manualized framework. The therapist must be able to provide structured support consistent with psilocybin-assisted therapy for depression.
Supportive presence during altered states
Maintain a calm, non-directive, supportive presence during the dosing session. Therapists are expected to witness the participant’s process and provide reassurance without steering the experience.
Monitoring for suicidality
Continuously assess suicide risk and respond rapidly to any indication of suicidal ideation. Therapists and the study team must use the trial’s suicide risk management procedures when needed.
15 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Study Details | NCT05710237 | Does Psilocybin Require Psychedelic Effects to Treat Depression?
Attribution: Does Psilocybin Require Psychedelic Effects to Treat Depression?
Source guideline: Open link
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Information extraction from sparse source material
Skill in identifying the absence of therapist/facilitator competency information when the source provides only general website text. This is important for accurate documentation and avoids unsupported assumptions.
Clinical trial record interpretation
Ability to interpret a ClinicalTrials.gov study record and extract relevant role-related information from registry text. This includes understanding the limited structured content available in the source and identifying what is and is not specified.
Data element definition awareness
Knowledge of registry data element definitions and how they affect interpretation of submitted study information. This supports accurate understanding of what information is expected in a trial record.
trial protocol paperEvidence score: 90
Psilocybin Therapy for Clinicians With Symptoms of Depression From Frontline Care During the COVID-19 Pandemic: A Randomized Clinical Trial
Attribution: JAMA Network Open, 2024
Source guideline: Open link
trial protocol paperEvidence score: 90
Clinical Research Protocol with psilocybin-assisted psychotherapy and Yale Manual reference
Attribution: Clinical Research Protocol
Source guideline: Open link
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Suicidality risk assessment and monitoring
Therapists and study staff must monitor suicidality throughout the study and respond promptly to any increase in risk. This is a central safety duty in a depressed population receiving an activating intervention.
Adverse event observation and escalation
Therapists are responsible for constant adverse event observation during dosing and for timely escalation of concerns. They must recognize psychological, psychiatric, and physical adverse events and involve medical staff as needed.
Informed consent facilitation
Personnel involved in consent must ensure consent is informed, voluntary, and documented properly. Consent is a process that continues throughout participation, not a one-time event.
18 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
RCT of Psilocybin-assisted CBT for Depression
Attribution: Psilocybin-Assisted Cognitive Behavioral Therapy for Depression
Source guideline: Open link
Preview competencies (1)
Study record management familiarity
The facilitator/therapist should understand how clinical study records are organized and submitted. This includes awareness of the ClinicalTrials.gov glossary and data element definitions used for registration and results reporting.
trial protocol paperEvidence score: 90
Development and Evaluation of a Therapist Training Program for Psilocybin Therapy for Treatment-Resistant Depression in Clinical Research
Attribution: Tai et al., 2021
Source guideline: Open link
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Establish therapeutic alliance
Build a trusting, collaborative relationship that supports a safe and meaningful psilocybin session. The therapist should be genuinely curious, present, and able to cultivate trust without being directive.
Use self-directed enquiry
Help participants direct attention to their own present-moment internal experience and explore it from multiple perspectives. This is practiced in preparation and used to support participants if challenging material emerges during dosing.
Support emotional tolerance during dosing
Monitor and regulate the therapeutic environment so emotional arousal remains within a tolerable range. Therapists help prevent transient anxiety from becoming overwhelming, prolonged, or counterproductive.
21 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Study Protocol and Statistical Analysis Plan for Psilocybin Cancer Anxiety Study
Attribution: ClinicalTrials.gov protocol file
Source guideline: Open link
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Psychedelic session preparation
Prepares participants for the dosing experience through psychoeducation, expectation-setting, and establishment of treatment goals. Uses preparatory sessions to reduce risk and support a structured therapeutic frame.
Participant selection and screening judgment
Screens participants for medical and psychiatric suitability and applies exclusion criteria to reduce risk. Requires judgment about whether the participant’s condition and history are compatible with psilocybin administration.
Set and setting management
Creates and maintains a safe, structured therapeutic environment conducive to psilocybin-assisted work. Uses environmental and interpersonal support to shape the experience.
19 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD
Attribution: Veterans PTSD psilocybin protocol (2023)
Source guideline: Open link
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Suicidality risk assessment and monitoring
Monitor suicidal ideation and suicidal behavior as a primary safety outcome. The protocol explicitly identifies these as key adverse safety concerns requiring ongoing attention.
Adverse event monitoring
Observe and document adverse events throughout treatment and follow-up. Safety monitoring is central to the study design and requires systematic recognition of negative effects.
Informed consent facilitation
Ensure participants provide written informed consent before participation. Facilitators involved in the trial must respect and support informed consent as a core ethical requirement.
7 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Psilocybin-Assisted Therapy as a Treatment for Depression
Attribution: ClinicalTrials.gov record
Source guideline: Open link
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Clinical trial record familiarity
The facilitator should understand how to interpret and use ClinicalTrials.gov study record information. This includes recognizing that the source is a registered study record with glossary and data element definitions referenced for accurate reporting.
trial protocol paperEvidence score: 90
Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial)
Attribution: Jensen et al., 2022
Source guideline: Open link
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In-session therapeutic support
Offer supportive psychological guidance during the dosing session. The facilitator must help the participant navigate the acute psilocybin experience safely and therapeutically.
Blinding-aware facilitation
Support participants in a double-blinded trial without revealing treatment assignment. The facilitator must provide care consistently across psilocybin and placebo conditions.
Post-dosing integration support
Provide psychological support after the dosing session to consolidate the experience and maintain engagement in treatment. This is part of the before-during-after support model described in the protocol.
8 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Induction Protocol for Psilocybin-Assisted Therapy in Treatment-Resistant Depression (TRD): A Pilot Study
Attribution: UNC trial record
Source guideline: Open link
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Study record management literacy
The facilitator should understand the ClinicalTrials.gov study record context and how study information is represented. This supports accurate interpretation of the trial source and any protocol-related responsibilities.
trial protocol paperEvidence score: 90
Comparative acute effects of mescaline, lysergic acid diethylamide, and psilocybin in a randomized, double-blind, placebo-controlled cross-over study in healthy participants
Attribution: Schmid et al., 2023
Source guideline: Open link
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Psychedelic dose-effect literacy
Understands the acute pharmacological and phenomenological effects of classic serotonergic psychedelics at moderate to high doses. Can anticipate that mescaline, LSD, and psilocybin may produce broadly comparable subjective alterations despite differing durations and pharmacokinetics.
Duration and timing management
Can plan and monitor sessions based on differing onset, peak, and offset times of psychedelics. Adjusts expectations and support needs according to the specific substance used.
Physiological monitoring
Monitors autonomic effects during the acute experience, including blood pressure and heart rate. Tracks for moderate cardiovascular changes and notes substance-specific differences.
7 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Psilocybin-assisted therapy of major depressive disorder using Acceptance and Commitment Therapy as a therapeutic frame
Attribution: Sloshower et al., 2020
Source guideline: Open link
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Competency extraction pending.
trial protocol paperEvidence score: 90
Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial
Attribution: Single-dose psilocybin-assisted therapy trial (2023)
Source guideline: Open link
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Monitor adverse events and acute safety
A core facilitator responsibility is active monitoring for adverse events during and after treatment. Although no serious adverse events were recorded in this study, safety surveillance remains an essential competency.
Assess and monitor depressive symptom severity
Clinicians need skill in evaluating depression severity using standardized outcome measures before and after treatment. The study used MADRS and BDI ratings to estimate symptom severity and treatment response.
Screen for medical suitability and stability
Safe facilitation requires screening participants for unstable somatic conditions and ensuring basic medical appropriateness for treatment. The trial included participants with major depressive disorder and excluded those with unstable somatic conditions.
5 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Psilocybin-assisted Cognitive Behavioral Therapy for Depression
Attribution: Psilocybin-assisted CBT trial protocol (2023)
Source guideline: Open link
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Psychedelic-assisted therapy training and supervised progression
Therapists/drug monitors must be specifically trained in psychedelic-assisted therapy methods and demonstrate competence through staged observation, co-leading, direct supervision, and ongoing consultation. Competence is not assumed from general clinical licensure alone.
Guiding participants through difficult psychedelic experiences
Monitors must competently support participants through fear, anxiety, panic, paranoia, or other distress during the acute psychedelic state using noncoercive psychological support before escalating to medical intervention. The protocol emphasizes verbal reassurance, encouraging acceptance, and helping participants tolerate transient altered states.
Suicide risk assessment and management
Therapists must monitor suicidality throughout the study and respond according to a structured suicide protocol, including lethality assessment, crisis counseling, escalation, and referral. Safety management extends beyond drug days to all treatment and assessment contacts.
19 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
Attribution: Raison et al., 2023
Source guideline: Open link
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Training and competence before participant contact
All facilitators completed study-specific training before working with participants. This implies that facilitators must be trained in both the protocol and the particular demands of psychedelic support.
Safety monitoring for psychiatric adverse events
Facilitators and site staff must monitor for psychiatric adverse events, including suicidal ideation and emergent distress. The trial used structured tools and clinical verification to detect risk.
Protocolized set-and-setting facilitation
Facilitators must deliver psilocybin sessions within a structured, manualized set-and-setting protocol. This includes preparing the participant, supporting the dosing session, and conducting postdose integration in a consistent way.
13 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial
Attribution: Davis et al., 2021
Source guideline: Open link
Preview competencies (1)
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The supplied source text contains only a browser/reCAPTCHA interstitial and does not include the guideline content needed to reliably extract therapist or facilitator competencies.
trial protocol paperEvidence score: 90
Does Psilocybin Require Psychedelic Effects to... [Clinical Research Protocol]
Attribution: ClinicalTrials.gov protocol, 2024
Source guideline: Open link
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Build therapeutic alliance and provide psychoeducation
Therapists are expected to establish a strong therapeutic relationship before dosing and prepare participants for the psychedelic session through psychoeducation and intention setting. This preparation is also a risk-mitigation strategy.
Facilitate safe in-session support during dosing
Therapists must provide continuous supportive presence throughout the 5-6 hour dosing session in a non-clinical environment while encouraging inward focus and responding to participant needs. At least one therapist must be present at all times.
Continuous observation for adverse events
During dosing, therapists are responsible for constant observation to detect psychological or physical adverse events promptly. Safety monitoring is prioritized throughout the protocol and especially during the acute administration period.
19 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Psilocybin Therapy for Clinicians With Symptoms of Depression From Frontline Care During the COVID-19 Pandemic
Attribution: Back, A. et al., 2024
Source guideline: Open link
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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.
Acute psychological response and emergency management during dosing
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.
16 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression
Attribution: Goodwin, G. M. et al., 2022
Source guideline: Open link
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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.
17 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
Attribution: Raison, C. L. et al., 2023
Source guideline: Open link
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Acute psychological response and emergency management during dosing
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, escalation, and disposition planning
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 and serious psychiatric risk assessment
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.
24 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Study Protocol
Attribution: von Rotz et al., 2021
Source guideline: Open link
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Acute psychological response and emergency management during dosing
Skill in providing non-directive psychological support during altered states of consciousness. The therapist must balance allowing spontaneous experience with active support when anxiety, avoidance, or distress emerges.
Acute psychological response and emergency management during dosing
Ability to monitor physiological and psychiatric safety throughout screening, dosing, and follow-up. This includes continuous observation during dosing and repeated checks at scheduled visits.
Suicide and serious psychiatric risk assessment
Ability to assess suicidality using structured tools and clinical judgment across the study. Suicide risk is a central safety focus and must be monitored repeatedly.
21 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Trial of Psilocybin versus Escitalopram for Depression
Attribution: Carhart-Harris, R. L. et al., 2021
Source guideline: Open link
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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.
20 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Trial of Psilocybin versus Escitalopram for Depression
Attribution: Carhart-Harris et al., 2021
Source guideline: Open link
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Safety monitoring for adverse events
Because adverse events were tracked and compared between groups, therapists/facilitators need to monitor, identify, and report adverse events during treatment.
Provide structured psychological support alongside treatment
All patients in the trial received psychological support in conjunction with medication administration, indicating that facilitators must be able to deliver structured supportive care as part of the treatment model.
Knowledge of major depressive disorder severity and symptom measurement
Therapists/facilitators need working knowledge of moderate-to-severe major depressive disorder and the interpretation of depressive symptom measures used to track outcomes.
5 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer
Attribution: Agin-Liebes et al., 2020
Source guideline: Open link
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Maintain scientific and ethical caution in representing benefits
Because the paper notes limited conclusions about efficacy due to the crossover design, clinicians have an ethical responsibility to avoid overstating treatment effects. Competence includes accurately presenting the evidence base, uncertainty, and limits of inference to patients and colleagues.
Assess and address cancer-related psychiatric and existential distress
Clinicians need skill in identifying and therapeutically addressing anxiety, depression, hopelessness, demoralization, death anxiety, and broader existential suffering in patients with life-threatening cancer. This includes monitoring change in these domains over time.
Long-term outcome monitoring and follow-up
Therapists/facilitators should monitor symptom outcomes over extended periods, as the study emphasizes sustained effects at 3.2 and 4.5 years. Competence includes maintaining follow-up contact and assessing durability of antidepressant and anxiolytic response.
6 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder
Attribution: Bogenschutz, M. P. et al., 2022
Source guideline: Open link
Preview competencies (3)
Preparation support
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 nondirective therapeutic stance
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.
23 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction
Attribution: Johnson et al., 2014
Source guideline: Open link
Preview competencies (3)
Monitoring smoking outcomes with biomarkers
Therapists/facilitators should be able to monitor smoking cessation outcomes using objective biomarkers alongside self-report. This supports accurate assessment of abstinence and treatment progress.
Structured smoking cessation treatment delivery
Facilitators must be able to deliver psilocybin only as an adjunct within a structured 15-week smoking cessation protocol rather than as a standalone intervention. This requires integrating psychedelic sessions with established tobacco cessation treatment methods.
Knowledge of psilocybin dosing and administration
Therapists/facilitators need working knowledge of the study’s psilocybin dosing approach and its role in treatment. This includes understanding moderate and high dose administration in a controlled clinical context.
5 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Psilocybin for alcohol use disorder: Rationale and design considerations for a randomized controlled trial
Attribution: O'Donnell et al., 2022
Source guideline: Open link
Preview competencies (3)
Safety eligibility assessment and ongoing monitoring
A core responsibility is to monitor safety throughout screening, dosing, and follow-up, and to ensure that participants continue to meet protocol-defined safety criteria.
Deliver manualized alcohol-use psychotherapy within a psychedelic treatment platform
Therapists/facilitators must be able to provide a structured, evidence-based, manualized psychotherapy program for alcohol dependence while embedding it within psilocybin-assisted treatment.
Maintain trial blinding and protocol fidelity
In a randomized controlled trial context, facilitators must adhere to protocol requirements and avoid behaviors that compromise blinding or introduce bias.
8 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Psilocybin in alcohol use disorder and comorbid depressive symptoms: Results from a feasibility randomized clinical trial
Attribution: Luquiens, A. et al., 2025
Source guideline: Open link
Preview competencies (3)
General psychedelic-assisted practice skills
Create and maintain a secure, contained environment that supports psychological safety before and during the psychedelic session. This includes structuring the room, session parameters, and therapist presence to reduce uncertainty and distress.
General psychedelic-assisted practice skills
Recognize and respond to medical or psychiatric adverse events during the session, including hypertension, severe anxiety, psychotic symptoms, and physical side effects. Safety monitoring is ongoing and may require psychiatric or physician intervention.
General psychedelic-assisted practice skills
Adopt a calm, reassuring, and accepting presence that supports the patient without excessive verbal intervention. The therapist should normalize variability in experience and avoid judgment or interpretation.
15 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Psilocybin or Nicotine Patch for Smoking Cessation A Pilot Randomized Clinical Trial
Attribution: Johnson, M. W. et al., 2026
Source guideline: Open link
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.
General psychedelic-assisted practice skills
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.
22 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Psilocybin-assisted cognitive behavioral therapy for major depressive disorder: A pilot trial
Attribution: Weintraub et al., 2024
Source guideline: Open link
Preview competencies (3)
Deliver manualized CBT alongside psilocybin treatment
Therapists/facilitators should be able to provide a structured, evidence-based cognitive behavioral therapy protocol as the psychotherapeutic component adjoining psilocybin treatment for major depressive disorder. The source frames manualized CBT as important for acceptability, feasibility, effectiveness, and dissemination.
Coordinate psychotherapy with staged psilocybin dosing
Clinicians need the applied ability to align psychotherapy sessions with the timing and structure of two psilocybin administrations. The study protocol required two doses, 10 mg and 25 mg one month apart, interspersed with 12 psychotherapy sessions over four months.
Knowledge of psilocybin-assisted treatment protocol
Therapists/facilitators should understand the basic treatment structure used in psilocybin-assisted CBT, including dose schedule, duration, and target population. This knowledge is necessary to deliver psychotherapy that fits the pharmacologic intervention.
7 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Psilocybin-assisted group psychotherapy and mindfulness-based stress reduction for frontline healthcare provider COVID-19-related depression and burnout: A randomized controlled trial
Attribution: Davis et al., 2025
Source guideline: Open link
Preview competencies (3)
General psychedelic-assisted practice skills
Able to identify, document, and follow adverse events during and after psilocybin-assisted treatment. Safety monitoring must extend through follow-up, not only during dosing sessions.
Suicide and serious psychiatric risk assessment
Able to assess suicidality as part of ongoing psychiatric safety monitoring. This is especially important in trials treating depressive symptoms with psychedelic-assisted psychotherapy.
General psychedelic-assisted practice skills
Able to facilitate group psychotherapy sessions that incorporate psilocybin as an adjunct to mindfulness-based treatment. This includes supporting participants through preparation, dosing, and integration phases in a structured clinical trial context.
8 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence
Attribution: Bogenschutz et al., 2014
Source guideline: Open link
Preview competencies (1)
Study record management literacy
Therapist/facilitator personnel should understand the clinical trial record context and related terminology used in study documentation. This supports accurate interpretation of study materials and reporting requirements.
trial protocol paperEvidence score: 90
Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression: The EPISODE Randomized Clinical Trial
Attribution: Mertens, L. J. et al., 2026
Source guideline: Open link
Preview competencies (3)
Supportive nondirective therapeutic stance
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.
Acute psychological response and emergency management during dosing
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.
Preparation and integration support
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.
20 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder — Protocol
Attribution: ClinicalTrials.gov NCT05065294
Source guideline: Open link
Preview competencies (3)
Psilocybin session facilitation
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.
Preparation and integration support
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.
Acute psychological response and emergency management during dosing
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.
22 additional competency entries are available in the full framework.
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trial protocol paperEvidence score: 90
Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression
Attribution: Goodwin et al., 2022
Source guideline: Open link
Preview competencies (0)
Competency extraction pending.
trial lab manualEvidence score: 80
The therapeutic alliance between study participants and intervention facilitators is associated with acute effects and clinical outcomes in a psilocybin-assisted therapy trial for major depressive disorder
Attribution: Janssen et al., 2024
Source guideline: Open link
Preview competencies (3)
Therapeutic alliance building
Establish and maintain a strong collaborative relationship with participants across preparation, dosing, and integration phases. The alliance is framed as central to both acute psychedelic experience and downstream clinical outcomes.
Preparatory psychotherapy
Deliver structured preparation sessions before psilocybin administration. The article describes approximately 8 hours of preparatory therapy as a core part of the intervention.
Integrative psychotherapy
Provide post-session integration to help participants process and apply psychedelic experiences. Integration occurs the day after and one week after dosing, as well as in later follow-ups.
23 additional competency entries are available in the full framework.
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trial lab manualEvidence score: 80
A PILOT MECHANISTIC STUDY OF Psilocybin-Assisted Therapy as a Treatment for Depression
Attribution: Protocol document
Source guideline: Open link
Preview competencies (3)
Psychedelic-assisted therapy facilitation
Provide structured psychological support before, during, and after psilocybin administration using a prepared, minimally directive therapeutic stance. Facilitation is intended to optimize set and setting, support the participant’s inner experience, and help integrate the dosing experience into daily life.
Continuous behavioral and mental status monitoring
Monitor the participant’s physical and psychological status throughout the dosing day and identify emerging distress or adverse reactions. Facilitators are expected to observe continuously and respond promptly to changes.
Release readiness assessment
Determine whether a participant is safe to leave the research facility after dosing. Release is based on mental status, physical stability, and resolution of peak drug effects.
21 additional competency entries are available in the full framework.
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trial lab manualEvidence score: 80
The Yale Manual for Psilocybin-Assisted Therapy of Depression
Attribution: Guss, Krause and Sloshower, 2020
Source guideline: Open link
Preview competencies (3)
Safety monitoring during dosing sessions
Continuously monitor physical and psychological safety during psilocybin sessions and ensure the participant can remain in a safe setting. Safety monitoring is central and includes vitals, behavior, and readiness for discharge.
Boundary management and consent for touch
Maintain clear, explicit boundaries around physical contact and protect participant autonomy. Sexual or erotic touch is prohibited, and all touch must be guided by prior consent and ongoing permission.
Psychoeducation about psilocybin-assisted therapy
Provide clear, accurate education about the treatment model, psilocybin effects, session structure, and the participant's role. Psychoeducation is used to prepare the participant for the experience and reduce confusion or unrealistic expectations.
22 additional competency entries are available in the full framework.
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trial lab manualEvidence score: 80
Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial
Attribution: Sloshower, J. A. et al., 2023
Source guideline: Open link
Preview competencies (3)
ACT-based case formulation
Therapists must understand participant distress through an Acceptance and Commitment Therapy lens and use that formulation throughout preparation, dosing, and integration. They identify psychological inflexibility processes and track movement toward or away from psychological flexibility.
ACT-informed psychoeducation and skills teaching
Therapists teach ACT concepts in a way that helps participants recognize depression-related patterns and build psychological flexibility. The manual expects direct instruction plus experiential learning.
Values clarification and committed action coaching
Therapists must help participants identify, recover, and translate values into concrete behavior change. The manual treats values work as central to depression recovery and integration.
24 additional competency entries are available in the full framework.
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trial sop guidebookEvidence score: 70
Evolving Guidelines for the Use of Touch During a Clinical Trial of Group Psilocybin-Assisted Therapy
Attribution: Back et al., 2024
Source guideline: Open link
Preview competencies (3)
Ethical use of touch
Use touch intentionally, supportively, and cautiously, recognizing its power as a nonverbal form of communication and its potential to cause harm or boundary violations.
Touch-related informed consent
Obtain and confirm touch consent privately before psilocybin administration while the participant is in an ordinary state of consciousness. Consent must include the possibility of considered touch, and it must not be renegotiated during the psilocybin session.
Reading verbal and nonverbal consent
Assess both verbal and nonverbal responses to touch, while recognizing that nonverbal communication may be ambiguous and prone to misinterpretation.
17 additional competency entries are available in the full framework.
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