A team of clinicians and researchers at COMPASS Pathways has developed a specific training program for delivering psilocybin therapy. Findings on the development and evaluation of their program, which was put into place for their clinical trials and which utilizes the investigational COMP360 (a crystalline formulation of psilocybin), were published in Frontiers in Psychiatry in February 2021. The therapy is focused on helping patients with treatment-resistant depression (TRD), which impacts 100 million people worldwide.

FDA granted COMP360 breakthrough status for TRD in 2018 and Phase IIb trials are ongoing across Europe and North America, with three doses being investigated. The Usona Institute has also received breakthrough status for studying psilocybin – their program is focused on the substance’s effect on major depressive disorder (MDD).

Interest in psilocybin (an active ingredient in magic mushrooms) has skyrocketed over the past several years, with an extra push hitting the US in fall 2020 when Oregon and Washington, DC, decriminalized the Schedule 1 drug. The cities of Denver, Oakland, Santa Cruz, and Ann Arbor had previously decriminalized psilocybin as well as other psychedelic substances (eg, MDMA) throughout 2019 and 2020, and additional cities and states are now pursuing similar legal changes. Several research centers have opened across the country in the past year, including the Johns Hopkins Center for Psychedelic and Consciousness Research, Mount Sinai Health System’s Center for Psychedelic Research, and Mass General’s Center for the Neuroscience of Psychedelics. They join more established centers running trials, such as those at UC San Francisco and the Multidisciplinary Association for Psychedelic Studies (MAPS).

Novel research and specialized training are needed because of the way psychedelic-assisted therapy is delivered. The treatment is unlike traditional psychotherapy or psychopharmacology. As described briefly by COMPASS, the approach designed for their trials involves three general stages:

  • Preparation – in which the therapist and patient get to know one another and build trust
  • Administration & Monitoring – the patient, lying down and wearing an eye mask, is given a dose of psilocybin (capsule), listens to a specially designed playlist, and is supported by the therapist during the session – which can last 6 to 8 hours
  • Integration – the patient and therapist discuss the experience and how to integrate any insights into behavioral change

FDA’s approval of COMP360 is tied to the combined approach of medication management and psychotherapy.

Psycom Pro spoke to co-author Elizabeth M. Nielson, PhD, a clinician at Depression Evaluation Services at the New York State Psychiatric Institute and Assistant Professor of Clinical Medical Psychology (in Psychiatry) at Columbia University Irving Medical Center, and Ekaterina Malievskaia, MD, the Chief Innovation Officer and Co-Founder of COMPASS Pathways.

Ekaterina Malievskaia MD

Ekaterina Malievskaia, MD

Elizabeth M. Nielson, PhD

Elizabeth M. Nielson, PhD

Psilocybin Therapy Requires a Combination of Psychotherapy and Medication Management

Psycom Pro: From your perspective, why is a combined approach to psilocybin therapy so important to the patient experience and outcome?

Dr. Nielson: The subjective experience of drug effects depends on psychological factors including expectations and what we learn to pay attention to. The use of a psychedelic in a therapeutic context requires attention to the psychological factors that contribute to the subjective experience of the acute effects of the drug. With psychedelics as therapeutic agents, we not only want to construct psychological spaces that are safe and reduce the likelihood of distress but that are actually geared toward healing. This is where the psychological support comes in, working synergistically with the psilocybin effects to create an experience that leads to healing.

These psychological aspects and subjective experience are not normally attended to in traditional pharmacological treatments, and psychological aspects of drug effects are largely excluded from psychotherapists’ training. Therapists who work with psychedelic-assisted treatments must bridge this gap.

Training to Deliver Psychedelic-Assisted Therapy: Key Considerations for Clinicians

Psycom Pro: As part of your Phase IIB study, you trained 65 HCPs across the US, Canada, and Europe and solicited their feedback. Considering that psychedelic-assisted therapy is not yet legal at the federal level, why did you feel this training was necessary and important?

Dr. Malievskaia: The training was essential so that we could have well-trained therapists on our psilocybin therapy trial, supporting patients in the way Dr. Nielsen describes. Psychological support is an integral element of psilocybin therapy and must be delivered by trained therapists in a consistent way, with as little variation as possible. This is critical for patient safety as well as for the controlled rigorous nature of a large-scale clinical trial.

Psycom Pro: Your training program consists of an interactive learning platform (20 hours), in-person training (5 days, small groups), clinical training, and follow-up individual mentoring and webinars. In-person training involves role-playing of clinical scenarios that are adapted from previous or current studies. In your study, what did the trainees find most difficult about this training? Did they report any major takeaways?

Dr. Nielson: Trainee therapists tend to be very motivated, compassionate, and enthusiastic – and they bring a great deal of skill and experience to the training. It really is necessary to have clinical experience and an existing psychotherapy practice when starting this work, in fact the COMPASS program requires at least 3 years of clinical experience, and many trainees have much more.

Psychedelic-assisted therapies ask therapists to let go of their own ideas about the patient’s situation and follow the patient’s process of introspection, insight, and self-discovery. I see that trainees sometimes have the urge to engage in their habitual ways of conceptualizing patient distress and the corresponding problem-solving or therapeutic intervention. One of the takeaways from training is that therapists recognize and learn to respond appropriately to this urge.

Psycom Pro: Clinical training, as agreed to with FDA as part of your study, must include four different psilocybin research sessions before a therapist is considered able to provide therapy independently. With psychedelic-assisted therapy just entering the field – but doing so quickly – where to do see therapists getting this training? Will COMPASS be offering training to clinicians? Are you working with any continuing education or medical education programs?

Dr. Malievskaia: At the moment, we have only trained therapists on our clinical trial. We wrote the paper on the training program because we wanted to share our learnings and experience, and to collaborate further with others on evolving the approach. If psilocybin therapy is approved, as we hope it will be in a few years, we will need therapist training on a large scale so that we can bring this to as many patients who might benefit as possible.

Psycom Pro: As psychedelics move further into clinical trials, and eventually clinical practice, do you anticipate that providers will need a waiver (as they do for buprenorphine as part of MAT) or specialized training to administer their use?

Dr. Nielson: The regulatory aspects of authorization to engage in psychedelic therapy work have not been determined yet, but lots of people are asking what this will look like. For patient safety, specialized training is required; there is much potential for harm if psychedelic therapy is provided by untrained therapists.

I hope that there will be a way for independent training providers to get credentialed to offer that training through a national-level system so that therapists have a choice of where to get their training, but we may be looking at a very complex patchwork of regulations and legislation such as we have with buprenorphine or medical cannabis. This patchwork creates confusion, stigma, and opportunity for harm caused by different laws between jurisdictions. As in those fields, psychedelic therapy patients deserve better, and I think a nationwide credentialing system is in order.

Patient Preparation Before Psychedelic Therapy

Psycom Pro: Because of the unique mechanisms of psychedelics, such as psilocybin, clinicians must put patients into a specific mental state to conduct this type of therapy. Can you share what preparation may be required leading up to a psychedelic-assisted therapy session – such as how a therapist must counsel the patient beforehand on what to expect? 

Dr. Nielson: Therapists work with participants to create a mindset of psychological safety and calm prior to psychedelic sessions. To do this we must employ our best relational skills, as well as provide safety information and review all procedures for the session. It is just as important to cover “what to expect,” as to cover what kinds of things are off limits and how any emergencies would be handed.

For instance, specifically stating what will happen in the event of a fire alarm is important because it alleviates worry about that kind of incident, even if the patient wasn’t aware of such a worry in the first place. We are trained to anticipate and preemptively assuage anxieties.

At the same time, we encourage an attitude of openness and curiosity toward whatever subjective experience the participant may have, without setting up specific expectations ahead of time that can lead to struggle with comparison and disappointment.

Psychedelic Treatment and Future Targets

Psycom Pro: Your program focused on using psilocybin therapy for treatment-resistant depression. What’s the latest on COMP360 and is COMPASS pursuing psilocybin or other psychedelic substances for the treatment of other disorders?

Dr. Malievskaia: Data from our current Phase IIB trial is expected in late 2021. COMP360 is also being used in a number of investigator-initiated studies (IISs) in institutions including Imperial College London, Aquilino Cancer Center, Kings College London, Columbia University, Sheppard Pratt, UC San Diego, University of Copenhagen, and the University of Zurich. These IISs are independent, signal-generating exploratory studies looking at indications in areas of unmet need, such as anorexia, autism, bipolar disorder II, body dysmorphic disorder, chronic cluster headache, and depression in cancer.

We are also looking at new compounds through preclinical research, including work at our Discovery Center, a collaboration with world-leading scientists at the University of the Sciences in Philadelphia, UC San Diego, and the Medical College of Wisconsin, Milwaukee.

 

More on Psychedelic-Assisted Therapy

Psycom Pro continues to cover the emergence of psilocybin, MDMA, and psychedelics in mental health care

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Last Updated: Apr 15, 2021