This paper (2022) introduced the EMBARK model for the provision of supportive psychotherapy in psychedelic-assisted psychotherapy (PAP) clinical trials. EMBARK was designed to overcome challenges that prior models have had in conceptualizing therapeutic change in psychedelic treatment. The model incorporates elements of non-psychedelic evidence-based therapies, therapists’ prior skills and clinical orientations, among other things, to determine specific factors that contribute to treatment outcomes.
Abstract
“The current standard of care in most uses of psychedelic medicines for the treatment of psychiatric indications includes the provision of a supportive therapeutic context before, during, and after drug administration. A diversity of psychedelic-assisted psychotherapy (PAP) models has been created to meet this need. The current article briefly reviews the strengths and limitations of these models, which are divided into basic support models and EBT-inclusive therapy models. It then discusses several shortcomings both types of models share, including a lack of adequate attention to embodied and relational elements of treatment, and insufficient attention to ethical concerns. The article then introduces the EMBARK model, a transdiagnostic, trans-drug framework for the provision of supportive psychotherapy in PAP clinical trials and the training of study therapists. EMBARK was designed to overcome challenges that prior models have had in conceptualizing therapeutic change in psychedelic treatment, incorporating elements of non-psychedelic evidence-based therapies, incorporating therapists’ prior skills and clinical orientations, delimiting therapist interventions for research standardization, and determining specific factors that contribute to treatment outcomes. The article explains EMBARK’s six clinical domains, which represent parallel conceptualizations of how therapists may support therapeutic benefit in PAP treatment, and its four care cornerstones, which reflect therapists’ broad ethical responsibility to participants. The article describes how these elements of the model come together to structure and inform therapeutic interventions during preparation, medicine, and integration sessions. Additionally, the article will discuss how EMBARK therapist training is organized and conducted. Finally, it will demonstrate the broad applicability of EMBARK by describing several current and upcoming PAP clinical trials that have adopted it as the therapeutic frame.”
Authors: William Brennan & Alexander B. Besler
Summary
INTRODUCTION
Psychedelic medicines are a distinctive class of pharmacotherapeutic interventions that are thought to reduce psychiatric symptoms by fostering acute and subacute shifts in a participant’s subjective experience. MDMA is expected to become the first FDA-approved drug that requires a psychotherapeutic frame. Although some actors are seeking to develop drugs that replicate the putatively therapeutic neuropharmacology of classic psychedelics while eliminating their subjective effects, the potential efficacy of this approach remains speculative.
A diversity of adjunctive psychotherapy models have arisen to support the use of psychedelic medicines in the treatment of a range of indications. These models differ in how much non-drug therapy time they offer, the extent to which they incorporate extrinsic, non-psychedelic psychotherapeutic knowledge and best practices, and their view of therapy per se.
It will focus on clinical trials treating specific indications that have examined the efficacy of long-acting classic psychedelics or MDMA, and will omit ketamine and short-acting psychedelics.
The current article introduces the EMBARK model of PAP, which was developed to provide an optimized therapeutic frame for training therapists to support therapeutic benefit in PAP clinical trials.
To create EMBARK, the authors surveyed a range of therapeutic approaches that have shown efficacy in conjunction with psychedelic treatment. They divided these approaches into basic support and EBT-inclusive models.
The EMBARK approach to medication-assisted treatment (PAP) is a model of PAP that includes preparation sessions, medicine sessions, and integration sessions. It is designed to address some of the strengths, limitations, and underdeveloped qualities of prior PAP models.
All clinical PAP trials take an inner-directed approach during the medicine session, and the differences in therapeutic approach between basic support and EBT-inclusive therapy models are found almost exclusively in the preparation and integration phases.
Strengths and Limitations of Basic Support Models
Several PAP approaches can be grouped under the label of basic support models, which focus on providing basic, non-psychotherapeutic support to a participant undergoing a course of PAP treatment. These approaches do not encourage clinicians to adopt an indication-specific set of interventions or predetermined theory of change.
Basic support models allow each participant to make meaning of their own medicine session, and thereby reduce the possibility of clinicians making poor-fitting interpretations that may disrupt positive treatment outcomes.
These models are likely to be appealing for cost-saving reasons, as they require less credentialed labor and require less time in the non-drug preparation and integration phases.
Basic support approaches have several clinical limitations, including a lack of skillful incorporation of evidence-based interventions and a lack of research rigor in that they do not operationalize much of what occurs between the clinicians and the participant during treatment.
Staff provided with minimalist, low-therapy training may be underprepared for challenging clinical situations, and the lack of an explicitly proposed, empirically grounded mechanism of therapeutic change may open the door for the inappropriate introduction of therapists’ personal beliefs about how psychedelics heal.
Strengths and Limitations of Evidence-Based Therapies-Inclusive Models
PAP models that incorporate elements of non-psychedelic EBTs into their clinical approach can be characterized as EBT-inclusive. These models may include preparation sessions that introduce concepts and tools from an EBT, and integration sessions that sift the elements of a participant’s medicine session experience that best fit desired treatment outcomes.
EBT-inclusive models have several strengths over basic support approaches, including the integration of therapeutic interventions and knowledge from extrinsic, non-psychedelic EBTs, a more developed framework for training therapists, and reduced risk of iatrogenic harm caused by improper clinician responses to challenging clinical events.
The limitations of EBT-inclusive approaches in PAP treatment stem from their introduction of potentially deleterious constraints into how therapeutic benefit is conceptualized. This may lead to missed opportunities for therapeutic benefit or encourage therapists to pressure participants into fitting its interpretive framework.
PAP therapists may degrade the therapeutic alliance and invalidate a participant’s personal understanding of a deeply meaningful experience if they shift the focus of integration sessions away from the relational or affective dimensions of this experience.
A constrained understanding of psychedelic phenomena may increase the risk of iatrogenic harm, and an EBT-inclusive model may burden study therapists with the challenge of becoming proficient in a potentially novel way of working, while disregarding much of the existing knowledge, skills, and awareness they would otherwise bring to their work.
Lack of Attention to Embodied Phenomena
Most PAP models to date have paid little attention to the role of embodied events in therapeutic outcomes, and have instead focused on cognitive and neural phenomena. This is less clear when applied to the more body-inclusive experiences elicited by psychedelic medicines.
Several qualitative studies of PAP participant experiences include accounts of unprompted somatic phenomena, such as vomiting or spitting, that diminished the perceived personal impact of undesirable psychic content or physical illness. The participants’ experiences of discharging unwanted material resonate with indigenous frameworks for the use of psychedelic medicines and with somatic psychotherapy approaches that suggest that harmful memory traces can be discharged through somatic events like sobbing, involuntary shaking, or trembling.
To date, PAP clinical trials have considered the mind to be the locus of therapeutic outcomes, but we suggest that a considered incorporation of practices for supporting and responding to somatic events may enhance treatment outcomes.
Lack of Attention to Relational Elements of Treatment
PAP models to date have framed treatment benefit from within a “one-person psychology” and have primarily invited participants to “go inward” to have an inner-directed experience with limited intervention from clinicians. However, some participants have still opted to engage interpersonally with the clinicians.
Prior approaches to working with classic psychedelics have provided little guidance on how to engage with altered relational dynamics. However, MDMA-assisted treatment may provide unique opportunities for relational repatterning work between participants and clinicians. It has been suggested that the strength of the therapeutic relationship in the preparation phase of a course of psilocybin-assisted treatment for depression predicts greater emotional-breakthrough and mystical-type experience in the medicine session, which in turn leads to greater reductions in depressive symptoms.
Insufficient Focus on Ethics
PAP treatment may present novel relational ethical challenges to clinicians, including increased suggestibility, disruption of interpersonal boundaries, heightened transference, and attempts to reenact traumatic early life dynamics. Failure to navigate these challenges may lead to harm to participants.
There is an unmet need for a more commensurate response to the added risk of harm in psychedelic-assisted psychotherapy (PAP). This response should include the development of psychedelic-specific codes of ethics for practitioners, attentiveness to personal risk factors in trial therapist supervision, and reminders placed in therapist training manuals to maintain healthy boundaries.
Conceptualizing Therapeutic Change
The EMBARK approach to psychotherapy is made up of six domains that facilitate working with events therapeutically. Each participant’s treatment experience will likely only occur within one or a few of these domains, and therapists are trained to flexibly employ the relevant domains.
Incorporating Extrinsic Evidence-Based Therapies
EMBARK was designed to be able to incorporate elements from several non-psychedelic EBTs and other therapeutic approaches without wedding itself to one. This allows it to reap the benefits of extrinsic EBTs without sacrificing the model’s conceptual multiplicity.
Delimiting Interventions
EMBARK provides therapists with a set of treatment tasks for each phase of treatment that can be completed by way of a wide range of interventions. These tasks are guided by a set of general guidelines that allow therapists to draw on their existing skill sets.
Determining Contributing Factors in Treatment Outcomes
A clinical trial that uses an EBT-inclusive model runs the risk of improperly characterizing the factors that contribute to efficacy. The EMBARK model provides a pluralistic approach to mechanisms of change that supports less biased, more exploratory inquiries into what treatment events support benefit.
EMBARK’S STRUCTURE
EMBARK’s foundational structure includes six clinical domains, four care cornerstones, and three phases of treatment. The phases explain how the other elements of the structure come together into a unified treatment approach.
EMBARK’s Six Clinical Domains
The EMBARK approach to treatment includes a set of related treatment events, specific therapist tasks and guidelines for interventions, and indication-specific treatment goals that follow meaningfully from phenomena in the domain.
Existential-Spiritual
Psychedelic medicines are well known to catalyze profound encounters with mystical or spiritual content, as well as existential concerns, such as mortality, alienation, or questions of life meaning. PAP participants often report profound experiences of an existential or spiritual nature, and these experiences have been found to correlate with a range of treatment benefits, including reductions in symptoms of depression and treatment-resistant depression, increased motivation to stop problematic cocaine use, and greater success in nicotine cessation.
Current research suggests that having a mystical experience during a medicine session may facilitate antidepressive outcomes, but providing support for a participant’s post-medicine spiritual self-development may contribute additional benefit. EMBARK therapists help participants with MDD to use mystical or spiritual phenomena as an impetus for spiritual growth. They prepare the physical treatment space in a way that demonstrates respect for the subjective sense of sacredness that may arise for the participant.
Logotherapy is derived from MI, despite not being an EBT itself, and teaches therapists to attend to their own biases and beliefs.
Mindfulness
EMBARK participants have experienced increased capacity for self-compassion and self-regulation after treatment, as well as a sense of “mental freedom” or “sovereignty” in how they relate to the workings of their own mind.
In the treatment of MDD, mindfulness has been found helpful in disrupting ruminative thought patterns, enabling more cognitive flexibility, and fostering a more compassionate stance toward oneself. EMBARK therapists teach basic mindfulness skills to participants and help them integrate whatever aspect of mindfulness arose for them.
Body Aware
PAP participants report that embodied phenomena are a notable part of their experience of a medicine session. EMBARK therapists are prepared to respond to embodied treatment events using the most widely accepted elements of novel somatic approaches.
EMBARK therapists train participants in basic somatic awareness before a medicine session and guide them back to optimal arousal using self-soothing interventions or therapist-participant touch-based interventions.
EMBARK therapists prioritize non-touch interventions and limit their touch-based interventions to basic supportive touch that minimizes points of contact between parties, and give participants a chance to reject any form of touch during preparation, immediately before the provision of touch in the medicine session, and at any time during the touch.
The Body aware domain shares some practical overlap with the Mindfulness domain, but the primary distinction is found in participants’ subjective experiences of how benefits arise and the integration goals that best support these benefits.
In the treatment of MDD, somatic phenomena may contribute to therapeutic outcomes in two ways: by disrupting one’s lived experience of their body and by forming a relationship with one’s body that opposes the recurrence of depressive symptoms.
Treating MDD will likely involve working with trauma, and classic psychedelics may have facility in treating trauma by way of similar disinhibitory mechanisms. When trauma symptoms appear, a skillful therapeutic response may facilitate lasting resolution.
Affective-Cognitive
During a medicine session, some PAP participants experience dramatic shifts in their emotions and cognition, and may confront maladaptive self-beliefs with a directness they would normally avoid. This domain serves as a space within EMBARK for incorporating approach-oriented practices for working with emotions and self-beliefs.
The EMBARK approach to MDD begins with the notion that many depressed individuals have developed a habitual response to challenging feelings that entails dimming their awareness of them and experiencing a characteristic depressive experience of feeling numb and withdrawn. Participants in PAP medicine sessions have often experienced a greater facility in reconnecting with this avoided material.
Relational
EMBARK therapists are trained to work ethically and efficaciously in the domain of practitioner-participant interactions through didactic and experiential processes discussed later under the Ethically rigorous care cornerstone.
In the treatment of MDD, relational events are framed as potential moments of relational repatterning that may reduce depressive symptoms. These shifts in social cognition may occur in a PAP medicine session and can be skillfully worked with in the integration phase.
Keeping Momentum
A course of PAP treatment is brief, and its most enduring benefits may continue to unfold well beyond the final session. The EMBARK approach recognizes this unique opportunity to support participants in making pro-therapeutic changes to their behavior or life context.
MDD or any other indication under study, posttreatment changes are expected to look very different for each participant. EMBARK therapists are trained to apply a broad lens to what helpful posttreatment change might look like.
EMBARK’s Four Care Cornerstones
The EMBARK approach rests upon four pillars of ethical care, which are woven into all levels of any EMBARK approach to a specific indication.
Trauma-Informed Care
This cornerstone reflects a recognition of the prevalence of trauma in PAP clinical trial participants and the need for therapists to be trained in how to identify and respond to trauma.
Marcela Ot’alora G., MA, LPC, contributed her approach to trauma-informed care to the EMBARK training program. Her training materials emphasize the SAMHSA six key principles of trauma-informed care, along with the additional principles of choice and autonomy.
Culturally Competent Care
The field of mental health has reached consensus that therapists must be able to provide care to those who differ from their therapist in terms of race, culture, gender, sexual orientation, or class. However, training therapists to consider these factors has often lagged behind this realization.
NiCole T. Buchanan, Ph.D., has led the training module on cultural competence in clinical work and has addressed topics such as the influence of the War on Drugs on People of Color seeking psychedelic treatment, and responding competently to intergenerational and collective content.
Ethically Rigorous Care
EMBARK incorporates ethical considerations into many aspects of its approach, including the guidelines it offers for therapist interventions, and supports therapists in their own ethical self-reflection and growth through ongoing supervision, participation in peer consultation groups, and other practices.
Kylea Taylor, MS, LMFT, taught this module in the EMBARK training. She discussed touch, multiple relationship, power differentials, suggestibility, and other psychedelic-relevant topics, and suggested practices for continued ethical development.
Collective Care
PAP participants’ struggles and symptoms are often influenced by the structural conditions of society. EMBARK therapists are trained to attend to structural factors in their work and are offered recommendations on how they can broaden their sense of their role and become more holistic advocates for the participants they have committed to serve.
Florie St. Aime led the EMBARK training in this cornerstone, which focuses on the implications of psychotherapy and PAP’s situatedness within deeply engrained systems of domination, anthropocentrism, and historical inequities for how suffering is treated in PAP clinical trials.
EMBARK’s Three Phases of Treatment
The EMBARK model is a three-phase treatment design that consists of non-drug preparation sessions, medicine sessions, and non-drug integration sessions.
EMBARK uses a six-domain approach for each phase of treatment, with therapists given general tasks and domain-specific tasks for each of the six domains. Therapists and participants collaboratively choose which integration goals they will pursue based on what arose in the participant’s medicine session.
Preparation Sessions
All EMBARK protocols have included three preparation sessions leading up to each medicine session. These sessions include building rapport and trust, explaining basic elements of PAP treatment, and answering participant questions.
Therapists prepare participants for potential benefit across all six domains by assessing their lived experience of their symptoms and their functional significance. This information is taken into consideration later during the integration phase when deciding what integration goals would be most supportive.
The preparation phase is more standardized than the later phases, and therapists are invited to bring in interventions from their preferred clinical orientation(s), as long as they conform to the guidelines that ensure that the intended utility of each task is conferred to the participant.
Medicine Sessions
The therapists maintain an agnosticism about which benefits and which domains will ultimately become most salient for a participant, and the pre-dosing therapist tasks serve a similar purpose to the tasks in the preparation phase.
Once a psychedelic medicine is administered, the therapists’ role becomes more responsive to the specific situation and less about a domain-agnostic approach to preparation. The EMBARK training program and indication-specific manuals provide support in identifying and responding to insession events.
The value of organizing preparation work by domains becomes clear during this phase, as many responsive interventions will draw upon work that was conducted with the participant during the preparation phase in that same domain.
Integration Sessions
During the first debrief session, the therapists and participant collaboratively determine what treatment goals might be best to work toward in integration. This involves debriefing and supporting the participant’s sense of what transpired in the medicine session.
EMBARK provides suggested integration goals along with guidelines and suggestions for working toward each of these goals. The selection process is guided by what transpired in the medicine session, as well as the participant’s previously stated intentions for treatment and the functional meanings of their symptoms.
All integration goals are framed in terms of three possible spheres of change: individual behavior, personal context, and broader context. Participants may benefit from taking collective action that addresses broader conditions in a way that feels congruent with their revised values or sense of self.
EMBARK is a model for psychosocial assessment and intervention that supports short-term PAP interventions in clinical trial settings. It is suggested that therapists and participants use their judgment to determine the number of integration sessions that would be supportive of the participant’s wellbeing.
CUSHION PRESENCE
A therapist’s presence during medicine sessions should be calm, unhurried, supportive, human, impeccably boundaried, openhearted, and non-judgmental. Therapists are encouraged to engage in self-directed practices of their choice to cultivate these attributes in themselves.
GROWTH AREAS FOR EMBARK
The authors of EMBARK have intended its development to be an ongoing, iterative process. In response to concerns that EMBARK may seem overwhelming, they have created integrative agendas and therapist checklists to help therapists develop a sense of where to direct their attention during treatment.
EMBARK’s inherently eclectic design may leave it prone to some of the same shortcomings attributed earlier to basic support models, particularly in the operationalization of interventions used in a clinical trial.
EMBARK also shares a limitation with EBT-inclusive approaches in that it is unclear if the efficacy of the EBTs is preserved by the way in which they are brought in.
EMBARK is a model for the use of psychedelic medicines that is situated within a Western medical framework. Its authors hope that others will find value in putting other legitimate models in dialogue with EMBARK.
EMBARK TRAINING
The EMBARK training approach is intended to train PAP clinical trial facilitators to basic competency in supporting participant benefit in a clinical trial. It consists of training in four areas: specific training modules in the EMBARK clinical domains and care cornerstones, training in specific skills required for working in a clinical trial, and experiential training.
Training in Domains and Cornerstones
EMBARK therapists undergo specific training in the knowledge, skills, and awareness required to support benefit in the six clinical domains. They also receive specific training in each care cornerstone to ensure that they can provide care in line with the full breadth of their ethical commitment.
EMBARK organizes its training around six domains and four care cornerstones, and recruits 10 different faculty members who are experts in each of these areas. This allows trainees to receive a variety of perspectives on how to conduct PAP treatment.
Indication-Specific Training
EMBARK is being adapted for different indications, including MDD, alcohol use disorder, anxiety disorders, etc. Each clinical trial that employs EMBARK invites clinical supervisors with expertise pertinent to the indication under study.
Clinical Trial Training
When the EMBARK approach is used in a research setting, study therapists must undergo training in skills relevant to conducting PAP in the context of a clinical trial.
Experiential Training
It has been suggested that personal experiences with altered states of consciousness may improve therapists’ ability to support participants and minimize relational harm by giving them a firsthand sense of the vulnerability and suggestibility engendered by psychedelic medicines. A clinical research approach called EMBARK includes an experiential training component, which may include an opportunity to take a psychedelic drug or an alternative practice. This component may introduce a source of bias into research.
EMBARK IN ACTION
The EMBARK approach is a method for conducting psychedelic medicine clinical trials that has been trademarked by Cybin Inc. The approach is also flexible enough to serve as the basis for therapist training.
Cybin’s proprietary CYB003 and CYB004 formulations will be used in upcoming clinical trials to target MDD, alcohol use disorder (AUD), and anxiety disorders. The EMBARK approach, with its flexible, open architecture, is applicable to all studies described here.
EMBARK is intended to continually evolve through collaborative input from research groups outside of Cybin that adapt the model for their own purposes. Some of the innovations made by Dr. Back’s study facilitators have become standard in other EMBARK manuals.
CONCLUSION
The field of PAP research is entering its own critical period of social learning, and it should carefully consider how it interfaces with existing psychological knowledge, lest it lose something essential.
We offer the EMBARK model as a staging ground for the creation of a syncretic treatment approach that synthesizes current knowledge in the field.
AUTHOR CONTRIBUTIONS
WB and AB developed the EMBARK model and collaborated on the organization of the manuscript. Both authors approved the submitted version.
FUNDING
Both authors received financial compensation from Cybin, Inc., during the time the EMBARK model was developed and this article was written.
Study details
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Neuroscience
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Theory Building
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Humans