Models of Psychedelic-Assisted Psychotherapy: A Contemporary Assessment and an Introduction to EMBARK, a Transdiagnostic, Trans-Drug Model

Psychedelic medicines are increasingly administered within psychotherapeutic frameworks because much of their putative efficacy appears to arise from acute alterations in subjective experience that, when properly supported, can translate into clinical benefit. Reiff and colleagues note that almost all clinical trials of classic serotonergic psychedelics and MDMA embed drug administration within a therapeutic context; nonetheless, a plurality of adjunctive psychotherapy models has arisen, differing in how much non-drug therapy time they provide, whether they explicitly incorporate non-psychedelic evidence-based therapies (EBTs), and how prescriptive they are about therapist interventions. The field lacks robust empirical evidence to guide which of these features most influence clinical outcomes. This article aims to (1) review contemporary PAP models, grouped into “basic support” and “EBT-inclusive” approaches, highlighting their strengths and limitations; and (2) introduce EMBARK, a transdiagnostic, trans-drug model designed to address perceived shortcomings of prior approaches. EMBARK was developed as an adaptable therapeutic frame for training study therapists and structuring psychotherapy in PAP clinical trials, with the intention that it can be tailored to particular drugs and indications and used both within Cybin-sponsored studies and by external groups wishing to adopt or adapt it.

Rather than reporting a clinical trial, the paper describes a conceptual development process in which the authors reviewed the extant PAP literature and models used in trials of long-acting classic psychedelics and MDMA. From that assessment they distilled common strengths and weaknesses of two broad model types: basic support models, which provide non-directive assistance and avoid adding extrinsic psychotherapeutic interventions, and EBT-inclusive models, which deliberately integrate elements from established non-psychedelic therapies. The authors identified underattended areas across models—embodied phenomena, altered relational dynamics, and heightened ethical risk—and used these as key design targets for EMBARK. EMBARK was constructed as a structured but pluralistic framework comprising three main architectural elements: six clinical domains (Existential-spiritual; Mindfulness; Body-aware; Affective-cognitive; Relational; Keeping momentum), four care cornerstones that foreground ethics and social context (Trauma-informed care; Culturally competent care; Ethically rigorous care; Collective care), and the standard three phases of PAP treatment (preparation, medicine, integration). For each domain the authors specified proposed mechanisms of change, therapist tasks and guidelines, and indication-specific integration goals. Manuals were written to operationalise these elements for specific indications (examples given include major depressive disorder and alcohol use disorder), and the approach was designed to allow therapists to draw from their existing modalities within stated guidelines. The paper also details EMBARK training as an element of methods for implementation: a 60-hour programme combining prerecorded material and live sessions (a ‘‘flip-class’’ design), ten core modules corresponding to the six domains and four cornerstones plus introductory and integrative modules, indication-specific modules, clinical-trial competence training (research ethics, documentation, safety screening tools), supervision and peer consultation, and an optional experiential component. The manuals and training were iteratively refined through collaborations with external investigators and facilitators, and the EMBARK materials have been prepared for use in multiple clinical trials and treatment settings.

The extracted text does not report empirical outcome data from clinical trials; no quantitative or inferential results are presented. Instead, the paper reports the tangible outputs of the model-development process and initial implementation steps. The core deliverables described are: (1) the EMBARK conceptual architecture—six clinical domains and four care cornerstones—each accompanied by domain-specific therapist tasks, intervention guidelines, and indication-tailored integration goals; (2) detailed, indication-specific manuals (examples: manuals for major depressive disorder and alcohol use disorder) that translate the domains into preparatory agendas, pre-dosing tasks, in-session responsive interventions, and integration goals; (3) an articulated training curriculum of approximately 60 hours using a flip-class format, including supervision and peer-consultation expectations; and (4) implementation plans and early adoption examples. EMBARK has been trademarked by Cybin but made available for external adaptation, and the approach is planned for use in Cybin trials of proprietary compounds (CYB003 and CYB004) targeting MDD, AUD and anxiety disorders. The model is also slated for use in a low-cost/no-cost clinic and has already been adapted for an academic trial treating COVID‑related burnout with psilocybin through collaboration with external investigators. Collaborations produced concrete refinements to the manuals and training, such as integration checklists, ‘‘cheat sheets’’ summarising therapist tasks, and reorganised guidance for managing challenging medicine-session events. The authors additionally report several self-identified implementation challenges uncovered during development: the breadth of competencies EMBARK requires from therapists, potential difficulties in operationalising and deriving adherence criteria given the model’s permitted intervention diversity, uncertainty about whether incorporated EBT elements retain their efficacy in this hybridised format, and the model’s deliberate positioning within Western medical and EBT traditions which limits direct incorporation of indigenous practices.

Reiff and colleagues interpret EMBARK as an attempt to avoid two extremes they identify in prior PAP approaches: the agnosticism of basic support models, which may miss opportunities to add therapeutic value and to standardise interventions for research purposes, and the rigid single-theory focus of some EBT-inclusive models, which may constrain recognition of therapeutically relevant phenomena and risk pressuring participants to conform to a narrow therapeutic frame. EMBARK’s six-domain, pluralistic architecture is presented as a middle path that preserves openness to diverse psychedelic-induced experiences while providing sufficient structure for therapist training, session tasks, and research operationalisation. The authors position EMBARK relative to earlier research by highlighting its deliberate attention to three underdeveloped areas: embodied phenomena (somatic events and ‘‘purging’’), altered relational dynamics between therapist and participant, and the distinct ethical challenges posed by heightened suggestibility and boundary vulnerability in PAP. They argue that embedding trauma-informed, culturally competent, ethically rigorous, and collective-care cornerstones into training and manuals mitigates risk and expands the model’s scope beyond purely intrapsychic mechanisms. Key limitations and uncertainties are acknowledged. The model demands a wide range of therapist competencies, which may be daunting and could complicate fidelity assessment; the allowance for therapists to use diverse interventions raises challenges for creating adherence criteria in research; it remains unknown whether the therapeutic potency of extrinsic EBT elements is preserved when they are selectively incorporated into EMBARK; and the model’s grounding in Western medical and EBT traditions limits its ability to incorporate indigenous knowledge directly. The authors also discuss the contested issue of experiential therapist training (therapists personally undergoing altered states), noting legal, ethical and bias-related concerns and leaving its inclusion to trial organisers' discretion. For future work, the authors recommend empirical evaluation of EMBARK’s contributions—ideally comparative trials that test EMBARK versus more prescriptive EBT-inclusive approaches—and continued iterative refinement informed by external collaborators. They stress the need for organisations adopting EMBARK to provide robust aftercare and to address structural factors affecting participants, recognising that meaningful post-treatment change may require interventions at individual, personal-context, and broader structural levels. Lastly, the authors invite outside groups to adapt and critique EMBARK so it can evolve through collaborative peer review.

The paper concludes that PAP is at a formative moment in which it must integrate useful elements of established psychotherapies without erasing its distinctive phenomenology and therapeutic possibilities. EMBARK is presented as a flexible, ‘‘plug-and-play’’ model intended to synthesise contemporary knowledge about PAP into a usable frame for therapist training and trial implementation, while remaining open to ongoing development through external adaptation and empirical testing. The authors offer EMBARK as a staging ground for judicious syncretism that preserves the plural ways psychedelic medicines may yield beneficial outcomes.