Raters & Therapists: Protecting the validity of your study’s data in a psychedelic trial

Psychedelic Clinical Trials, Clinical Trials

Psychiatry has long embraced treatment options other than pharmaceuticals. So, it should come as no surprise that as the field explores the use of psychedelics as treatment options for mental illnesses, they are studying the use of psychological therapy alongside them. This is called “psychedelic-assisted psychotherapy” (PAP). But in a clinical trial setting, what role does a therapist play and how do they affect the clinical trial data?

Worldwide Clinical Trial’s Rolana Avrumson, MS, Vice President, Clinical Projects, Clinical Assessment Technologies has supported the psychedelic trials Worldwide has conducted, working with therapists and raters to understand and deliver their roles in accordance with the protocol. We connected with her to answer a few questions about how these roles function:

When should a psychedelic trial utilize a therapist?

Rolana: In a psychedelic clinical trial, therapists should be utilized if the dose is high enough to produce a hallucinogenic effect in the patient. This effect can last for several hours, so patients must stay onsite under close monitoring for their safety and the safety of those around them. A therapist will remain in the room with the patient, providing psychological support throughout the experience.

Under the influence of a psychedelic, a patient may have troubling feelings or difficult memories arise. The therapist will help them work through it and process the inner turmoil they are facing. As with any successful therapy session, a patient should feel trusting towards and comfortable with the therapist supporting them. Establishing a bond ahead of the session is a key part of the experience.

Does administering therapy while under the influence of the drug pose a risk to the validity of the study data?

Rolana: Traditional therapy like cognitive behavioral or psychodynamic therapy is centered around the patient, responding to their subjective experience and helping them rethink and reframe their patterns of thought and behaviors. In contrast, PAP is more standardized, responding to the patient’s experience, but delivering therapy within a standard framework. Therapists receive extensive training to deliver this type of therapy in the context of a trial. Standardization protects the reliability of the data collected from each patient.

Of course, the therapist can still have some impact on the patient’s experience with the psychedelic. Therapy will be different depending on who the therapist is and how the patient feels about them. That’s why it’s important to have trained therapists delivering a very manualized therapy.

Since the therapist’s objective is to provide psychological support for the patient, they do not collect the endpoint data. The rater collects outcome measures from the patient. The therapist and rater need to be two different people, and they must not interact.

What risks does the rater face in collecting accurate data?

Rolana: Raters are collecting clinician-reported outcomes (ClinROs) after or on a separate day from the psychedelic session. If not managed properly, the blind can easily be broken because the patient and therapist can tell if the patient is in an altered state. People under the influence of hallucinogens can also have a visible difference in appearance. For these reasons, the rater must be separated from the patient and therapist during dosing to maintain the blind and remain objective in their rating of the primary endpoint.

It’s also possible that during a rating session, a patient brings up their psychedelic experience. The assessments are interview-based, and they are asking very personal questions. Patients should be aware ahead of time that the rating session has a different purpose than the therapy session. They should not expect therapy in the rating sessions and discussing their psychedelic experience is not appropriate, as it could impact the rater’s assessment and unblind them. Interactions with the rater need to remain straightforward and neutral.

What responsibility does the patient have to protect the validity of the study data?

Rolana: Sites need to ensure that patients understand the difference between the therapist and the rater, and how to interact with them. Patients should understand that the therapist helps them through the experience, but everyone else they interact with on-site is there to remain objective to truly understand the impact of the drug. We’ve seen patients struggle with this difference, feeling they have a warm and comfortable connection with their therapist and a perceived coldness from the rest of the people at the site. Although maintaining appropriate research rapport does not necessarily equal a “cold” interaction, neutrality is encouraged, and they must understand the boundaries and roles the people they interact with are upholding.

You can find more details on raters and therapists, as well as other operational considerations for psychedelic trials in the recent webinar our experts hosted: “Demystifying Complex Operations in Psychedelic Research.” 

Worldwide Clinical Trials is a prominent CRO in the psychedelic clinical trial space. Learn more about how we can help you execute your psychedelic trial and find additional resources to help you execute your psychedelic trial successfully.  

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