UK-based mental healthcare company Compass Pathways recently revealed details of their new FDA approved psilocybin therapist training program, developed for use in Compass clinical trials and studies conducted by academic partners. In a paper recently published in Frontiers in Psychiatry, psychedelic and mental health researchers laid out a newly developed, company-wide approach, which aims to bring structure and consistency to therapist training in an effort to reduce variability in the psychological support provided during clinical therapy sessions with Compass’ patented synthetic psilocybin, COMP360.
The training program was initially created to support Compass’ psilocybin therapy clinical trials for treatment-resistant depression, or TRD. Compass consulted several leading psychedelic-assisted therapy professionals to help develop the method, which in its current form, consists of four training components and an evaluation system. The program also outlines the therapeutic approach therapists should follow while providing psilocybin-assisted therapy, an integral part of the therapeutic process that ensures patient safety.
Ekaterina Malievskaia, chief innovation officer and co-founder of Compass Pathways, told Lucid News in an email, “We published this paper to make our training methodology and model of psychological support openly available. We are currently developing academic and clinical collaborations to further improve content and training methodology and will continue to share data and insights about the program as we gain them.”
In recent years, Compass Pathways has been in the spotlight for its transition from a charity to a for-profit business, and its controversial patent claims. As the largest publicly traded company in the psychedelic industry, Compass’s actions could heavily influence the future of psychedelic therapies. For this reason, influential observers in the psychedelic space have openly debated who should be able to patent and profit from psychedelics.
In response to questions about Compass’s aggressive stance on patents and their new training program, Malievskaia said, “The training program we have developed and shared, is part of our clinical trial for our COMP360 psilocybin. We seek patents that protect our investment in our innovation, which includes our drug substances and how they are used. We are obviously not trying to patent soft furnishings, or listening to music, or hand holding, or any of the items pulled out of context from our patent applications in social media commentary. And we are not preventing others from developing their own programs with their own products.”
Malievskaia says that while therapists who complete the training with Compass will sign contracts at the research sites where they are providing therapy, Compass will not prevent them “from working with others in the field of psychedelic research specifically or mental health more broadly.”
Compass is one of the first psychedelic companies, following The Multidisciplinary Association for Psychedelic Studies, to develop company-wide clinical therapy training protocols. Other companies, such as MindMed, have recognized the need for more clinically trained therapists and invested in academic institutions to help develop those training programs. While clinical training programs share similar elements – including online or video learning, in-person practice, and role-play – they are often developed for use with a specific substance in studies that treat a single illness. Compass’ method was developed for use with its proprietary synthetic psilocybin and will not be available to those working outside the company’s therapeutic program.
Compass’s Clinical Trial for Treatment Resistant Depression
In 2018, Compass was granted FDA breakthrough therapy designation for its psilocybin therapy program that uses COMP360, a synthetic psilocybin formulated and patented by Compass, in its clinical trials studying TRD. The trials aim to determine the safety, efficacy, and optimal dosing of COMP360 for patients with TRD.
After a pandemic enforced pause in 2020, the phase IIb trials for TRD using COMP360 are now nearing completion. The compound and therapeutic methodology has been tested in 216 patients across 21 sites in Canada, the U.S. and Europe with results expected later this year.
Compass said in an announcement that the new training program helps to address the variability in the therapeutic process across research sites. According to Compass, a systematic approach to training therapists ensures better care and safety of patients, maximizes research impact, and helps to meet approval needs for continued research.
“Since psychological support is an integral part of the therapy, we need to show regulators a clear theoretical framework for this support which is consistent across all trial sites and therapists,” said Malievskaia. “We worked with a group of leading experts in the fields of psychological therapy and psychedelic research to create a manual and to deliver the training, so that we had a group of specially trained therapists who could provide consistent, high quality care to patients on the trial.”
Role of the Therapist and Therapeutic Model In Compass Clinical Research
Regulators, such as the FDA or Research Ethics Committee, mandate psychological support for safety purposes in psychedelic-assisted therapy. It is the role of the therapist to provide that support.
In addition to ensuring physical safety, therapists need to be able to provide psychological safety by helping participants engage with their psychedelic experiences, including any challenging parts of the journey, in a non-threatening and manageable way. Compass’ therapist training manual relies on two key principles to do this: self-directed inquiry and experiential processing.
“Self-directed inquiry refers to the development of the participant’s own skill in taking an attitude of open curiosity toward their subjective experience, and experiential processing refers to sustaining attention on that experience in order to develop insight out of it,” says paper co-author Dr. Elizabeth Nielson, co-founder of Fluence, a psychedelic therapy education company. “Using these principles, therapists assist participants in developing a way of relating to their own experience that carries through the treatment and can inform how they proceed afterward.”
Compass has integrated these two principles into the three-step therapeutic model commonly found in psychedelic therapy research: preparation, session, and integration. With the support of the psychedelic therapist, these steps help the participant build trust, move “in and through” their psychedelic experiences, and provide space for reflection. Compass utilizes this three-step approach in their therapeutic model and training program, selecting therapists who can competently navigate each step.
“We consider it a good standard of ethical practice that clinical psychedelic sessions should not be given without preparation, support during, and integration afterward,” says Nielson.
Selection of Therapists
To ensure research participants receive high quality psychological care during the phase IIb study, program developers devised a selection process for therapists based on specific qualities and qualifications.
First, therapists had to meet “country, state, and institution-specific requirements,” including being a licensed mental healthcare practitioner in good standing with clinical experience in areas related to psychotherapy. For study sites in the U.S., all therapists were required to have at least a master’s degree to meet FDA standards.
Second, therapists had to undergo an interview process with the Compass training team to discern their level of clinical experience, motivations for joining the study, and knowledge of Good Clinical Practice-compliant research. Because the candidate’s backgrounds were in a variety of mental healthcare disciplines – nursing, psychiatry, psychology, PhD mental health specialties – each one was screened for qualities that demonstrated an ability to remain calm and reassuring, such as patience, openness, and an “ability to care for people experiencing severe psychological distress.”
The Training Program
During the development of the new training program, Compass says it trained over 65 qualified therapists at their 21 phase IIb research sites. According to the authors of the paper, therapists worked closely with program developers to provide feedback and successfully progress through the four component program, which includes an online learning platform, in-person training, clinical training, and ongoing individual mentoring and continuing education.
Proceeding in a stepwise fashion, therapists are not able to independently lead psilocybin therapy sessions in a COMP360 clinical study until they complete the first three steps of the training. This involves first becoming acquainted with psilocybin therapy research by watching video modules and reading training materials on an online learning platform. Once therapists-in-training complete the online, self-paced portion, they take part in a small group, in-person training with Compass trainers.
Over the course of five days, trainers and trainees role-play clinical scenarios that have been adapted from previous or current psilocybin research studies and provide feedback on each others’ performance. This portion of the training is an opportunity to build community and observe the strengths of each therapist to determine if they are a good fit for the study. While some advocate for personal psychedelic use as part of a training program, Compass says it does not include opportunities for this type of experience, “yet respects and allows for discussion of therapists’ experiences during the training.”
If a trainee exhibits competency in the interactive training, they move onto clinical training. According to the paper, the FDA requires all therapists to “gain clinical experience in at least four different psilocybin research sessions before leading psilocybin sessions independently.” However, this requirement can be fully or partially waived if a therapist has already provided support to participants in other psychedelic therapy trials. All therapists-in-training in the Compass program eventually assist lead therapists at phase IIb trials to obtain feedback and gain a deeper understanding of the clinical setting. As the authors of the paper note, this portion was the most challenging but rewarding part of the program for therapists-in-training.
“The clinical training component is where therapists begin to apply the skills they have acquired to the true work with study participants. They come to this clinical training with substantial preparation, but are meeting a new challenge when working with participants who, as part of our patient population, are struggling with depression and taking psilocybin as part of the study,” says Nielson.
Nielson estimates that therapists could complete portions one through three of training in as little as five months, but this phase could take longer depending on the demands on a therapist’s schedule. However, once therapists-in-training are eligible to lead psilocybin sessions on their own, they are expected to “engage in mentoring sessions at least once a month and to engage in continuous professional development.” Trainers continue to observe therapists’ behaviors and performance throughout the mentoring and professional development portion of the training, which mainly involves clinical supervision and webinars.
Therapists were also rated for fidelity using procedures that were designed to ensure consistency and replicability of the training program. “Demonstrated fidelity to the approach is a regulatory requirement for research,” write the authors of the paper. All therapists in the training program also used a fidelity scale to self-rate their clinical performance.
The authors of the Frontiers in Psychiatry paper note that as interest in psychedelic-assisted therapies continues to grow, there is an “increased need for specially trained therapists.” With these requirements in mind, scalability became an important factor in the development of the program.
Currently, the Compass training, which is provided free of charge, is only available to therapists who want to work with the Compass-sponsored TRD trials or in investigator-initiated studies (IISs) that use COMP360. As Compass’ research and that of their academic partners continues to grow, however, the authors of the paper foresee the training program growing.
“There are quite a few investigator initiated studies underway (or soon to start) for other indications including anorexia nervosa and body dysmorphic disorder,” said Nielson. “But it’s important to remember that this training program is for research purposes only at this time, and if the approach is approved for use with COMP360, that would not indicate it is necessarily safe and effective to use with other compounds.”
Nielson notes, however, that the Compass training approach is already undergoing refinement with the anticipation of expansion, especially as the TRD study moves from phase IIb to phase III. Program developers are also considering crafting specific programming for trainers of this approach, and expanding online training content. They are also looking into the possible benefits of machine learning to improve fidelity measures and training methods.
Considering the future of the program, Nielson observes that it “brings high-quality education to therapists working on clinical trials such that the practice is made accessible within mainstream medical and mental healthcare practices.”
“This trajectory of professionalization is important in reducing stigma and growing the acceptability of the idea of psychedelic-assisted therapy,” says Nielson. “I hope the training program will continue to play a vital role in this way as the education of therapists and those who will deliver care is a critical piece of the dissemination of empirically-supported treatment.”