My Research Study

Psychedelic Therapy Facilitation Approaches and Practices in Naturalistic Settings

Abstract: Psychedelic therapy is demonstrating safety and efficacy in treating mental illness at a time when novel treatments are desperately needed to address the nation’s mental health crisis, with one in five Americans struggling with mental illness annually. To date, scientific data informing psychedelic policies and approaches overwhelmingly comes from clinical trials that demand highly controlled environments and strict protocols. In fact, surprisingly little scientific data are available from non-clinical, real-world settings. While data collected from clinical trials are essential, clinical settings rarely resemble naturalistic settings where the vast majority of people take psychedelics. Without data from non-clinical and diverse settings, understanding of psychedelic therapy is incomplete and cannot account for real-world naturalistic applications.

Furthermore, the lack of diversity within psychedelic therapy research has been a significant concern, characterized by a predominant representation of individuals from white, male, and Western-educated backgrounds. This lack of diversity limits perspectives, experiences, and cultural understandings in shaping research and policy. Thus, as new practices and policies are developed in the field, it may prove beneficial to venture outside highly controlled settings and homogenous stakeholders to gather data from underrepresented and diverse underground psychedelic therapy facilitators about their approaches, practices, and perspectives.   

To address limitations and gaps in the emerging field of psychedelic therapy facilitation, I seek to conduct interviews and surveys with underground psychedelic facilitators. My study goals are to 1.) generate qualitative data that examines facilitators’ values, approaches, and practices; 2.) characterize emerging trends in psychedelic facilitation practices, potentially revealing safer and more effective ways to treat mental health; and 3.) include the voices of underrepresented facilitators in the scholarship, thus promoting more informed and equitable public policy and psychedelic therapy practice. The resulting data could help inform psychedelic theory, practice, future research, and the broader community as decisions are made about therapeutic practices and public policy.

Institutional Review Board: Contact the Institutional Review Board (IRB) if you have questions regarding your rights as a research participant. Also, contact the IRB if you have questions, complaints, or concerns which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at irb@hsc.utah.edu.  IRB Application #00165069 

Research Participant Advocate:  You may also contact the Research Participant Advocate (RPA) by phone at (801) 581-3803 or by email at participant.advocate@hsc.utah.edu. If you have any questions or complaints, or if you feel you have been harmed by this research, please contact Miriam Kaiyo, University of Utah, Family and Consumer Students Department, at (801) 599-3299 or u0166707@utah.edu. 

The Why Behind My Study

The United States is experiencing a mental health crisis, with one in five Americans struggling with mental illness annually (CDC About Mental Health, 2022). Rates of trauma-based disorders like addiction, depression, anxiety, and post-traumatic stress disorder (PTSD) are skyrocketing, especially for marginalized communities facing structural and significant barriers to treatment (2). Treatments include psychotherapy and pharmacological approaches which have been the conventional methods to address trauma-based symptoms for the past fifty years. While these approaches offer relief, they do not cure mental illness (3), and are criticized as being ineffective (4). Economically, the cost of mental illness is astronomical. One conservative study estimated a loss of earnings totaling almost $200 billion annually (5). As these growing concerns expose weaknesses in our current healthcare system, there is an urgent need for improved approaches and treatments that address the worsening mental health crisis in the United States. It is in this context that psychedelic substances have taken center stage as a possible solution and novel treatment in the search for improved mental health care.   

Clinical trials show that multiple psychedelic substances demonstrate safety and efficacy in treating many mental health conditions. For example, MDMA has consistently reduced symptoms associated with post-traumatic stress disorder (6), and psilocybin is showing efficacy in helping with treatment-resistant depression, end-of-life anxiety, and obsessive-compulsive disorder, among others (7). The clinical outcomes have been so promising that the U.S. Food and Drug Administration has designated both MDMA and psilocybin “Breakthrough Therapies,” meaning that these substances demonstrate substantial improvement for mental health outcomes over other therapies and clinical trials can be fast tracked (8). Other psychedelic substances are also being studied for their healing properties. For example, ibogaine—a strong psychedelic from an African root—has been studied as a treatment for substance abuse (9). LSD has been widely studied in the treatment of multiple mental illnesses including anxiety, depression, and alcoholism (10). N, N-dimethyltryptamine (DMT) has been studied as a way to help relieve depression and anxiety (11). Spravato or esketamine–the “S” form of ketamine received FDA approval for being used in the treatment of depression (12). With preliminary studies showing positive outcomes, perhaps psychedelic therapy may be the very tool needed to help treat the pervasive problems of anxiety and depression in western society.

While ingesting psychedelics alone may impact mental health outcomes, psychedelics used in combination with therapeutic practices facilitated by a therapist, guide, or “trip-sitter” is what mainly has the attention of governments, western medicine, and research. With this guided approach, a facilitator administers and oversees the psychedelic session. Before a psychedelic or dosing session, a facilitator will typically help a client with various types of preparatory work, increasing readiness and improving the potential for a beneficial psychedelic experience. Preparation might include one or more conventional therapy sessions addressing mental health issues, education about the substance and its effects, intention setting, establishing the therapeutic relationship, and developing skills like mindfulness or breathwork (13,14). During the dosing session, facilitators typically work to ensure the safety and comfort of an individual. Some may employ various therapeutic practices and approaches to support an individual in their process, including being an empathetic listener, reminding an individual that sometimes challenging experiences are essential for overall healing, and emphasizing the innate healing intelligence of client (15). After the dosing session, a facilitator or coach may support an individual with integration work that is believed to elongate or sustain any positive outcomes. Integration sessions encourage individuals to process their experiences, ideas, emotions, and insight gained during or after their dosing session (14). Some facilitators might support integration through encouraging the client to engage in art or movement, spending time in nature or journaling, incorporating new rituals and practices like prayer, meditation, or breathwork, and setting goals that incorporate insights gained from the psychedelic experience, etc. (14). These types of therapeutic facilitation practices are being studied to determine how they affect clinical outcomes, and which practices and protocols should be considered for psychedelic therapy.   

Limitations in Psychedelic Therapy Research & Applications

While there is much optimism regarding the research regarding psychedelic therapy, there are some important limitations. First, not everyone stands to benefit from psychedelic therapy on its current medicalized trajectory. Should the federal government legalize the medical use of psychedelics, treatments are expected to be prohibitively expensive. For example, MDMA-assisted therapy treatments could cost more than $12,000 (16), and according to KetamineClinicsDirectory.com, a single ketamine infusion averages between $400 to $2,000. The rationale behind these high costs makes sense: to ensure safety and efficacy, facilitators will need to be trained and licensed, two facilitators will be required for dosing sessions, intensive screening of clients will be required, on top of additional preparation and integration work before and after dosing sessions (17). The high costs of psychedelic treatment will most certainly exclude those from lower socio-economic status communities, mainly marginalized communities who already disproportionately struggle with significant health disparities.   

Another concern regarding psychedelic therapy research deals with generalizability, and specifically, its lack of racial inclusivity. Due to financial and logistical restraints, research on psychedelic therapy suffers from low sample sizes, potentially jeopardizing the generalizability of the results (18). Furthermore, despite the fact that many foundational aspects of psychedelic therapy can be attributed to Indigenous healing practices (19), there is a striking lack of racial inclusivity in the composition of psychedelic facilitators, researchers and those being researched. While efforts are being made to diversify the psychedelic renaissance, the most dominant accounts of psychedelic history are from western, white, college-educated, and male perspectives, excluding Indigenous and other diverse voices and contributions to the field (20). Also, an overwhelming majority of psychedelic research participants have been white—some samples consisting of 100% Caucasian participants (21), giving reason to question the generalizability of clinical outcomes (22). The lack of inclusivity and research generalizability weakens the potential for current psychedelic practices to address the nation’s mental health needs, especially for under-resourced and marginalized communities.

Also, in the western medical approach, psychedelic therapy practices, programs, and policies are highly informed by clinical trial outcomes (17). For the purposes of legalization and integrating psychedelic therapy into the western medical framework, scientific protocols are necessary to demonstrate the substances’ safety and efficacy. For example, studies must take place in highly controlled environments, utilizing strict practices (23). But laboratory settings rarely resemble naturalistic settings where the majority of people take psychedelics (18). For example, in laboratory settings, psychedelic therapy is usually administered by two trained professionals which isn’t common in naturalistic settings (24). The set and setting of psychedelic use is considered paramount in influencing an individual’s outcome. As such, the research coming out of laboratory settings—while valuable—is incomplete and cannot account for or predict real-world naturalistic use of psychedelics and outcomes. In this way, real-world representation and understanding of psychedelic therapy including Indigenous, spiritually-focused, and other underground practices among diverse populations are important in the shaping of public policy and psychedelic knowledge, especially considering that most Americans won’t be able to access psychedelic treatment from trained medical experts in highly controlled clinical settings. Even so, surprisingly little data is available regarding U.S. psychedelic therapeutic practices in non-medical, non-clinical, real-world settings. Without real-world representation and data to complement the clinical trial outcomes, the psychedelic renaissance risks excluding huge swabs of American society, especially marginalized communities who are in most need of novel healing modalities and approaches. 

Data on psychedelic facilitation in naturalistic settings would allow for a broader and more complete understanding of how people work with psychedelic substances. For example, it may be beneficial to know who is facilitating underground psychedelic therapy and what are their backgrounds. How were they trained? How are they conceptualizing safety, inclusion, and accessibility in their practice? What approaches, protocols, ethical standards, and values do they bring to their practice? What outcomes are they seeing in their clients? Is the work helping relieve mental health ailments? What wisdom or advice would they share with the broader community on how to work with psychedelic medicine? Intentionally seeking out and including the diverse voices of those facilitating underground therapeutic psychedelic sessions may reveal more effective, creative, and inclusive ways to facilitate psychedelic healing. This information could prove invaluable to individuals, future facilitators, under-resourced and marginalized communities, and the broader community as decisions are made about psychedelic use, safety protocols, therapeutic practices, and public policy.

To address this gap in the research, I seek to conduct confidential interviews and gather anonymous survey data from psychedelic facilitators. My goals are to gather the approaches, practices, and protocols of psychedelic facilitators who are providing therapeutic support to their communities, outside of a clinical setting and among diverse populations. With the data, I hope to congregate, organize, and characterize emerging trends in facilitation, along with client outcomes. Upon data analysis, I plan to disseminate the research findings to psychedelic stakeholders and the wider community, including mental health providers and public policymakers.

References

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2. Michaels TI, Purdon J, Collins A, Williams MT. Inclusion of people of color in psychedelic-assisted psychotherapy: a review of the literature. BMC Psychiatry. 2018 Dec;18(1):245. 

3. Sessa B. The 21st century psychedelic renaissance: heroic steps forward on the back of an elephant. Psychopharmacology (Berl). 2018 Feb;235(2):551–60. 

4. Bickman L. Improving Mental Health Services: A 50-Year Journey from Randomized Experiments to Artificial Intelligence and Precision Mental Health. Adm Policy Ment Health Ment Health Serv Res. 2020 Sep;47(5):795–843. 

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6. Amoroso T, Workman M. Treating posttraumatic stress disorder with MDMA-assisted psychotherapy: A preliminary meta-analysis and comparison to prolonged exposure therapy. J Psychopharmacol (Oxf). 2016 Jul;30(7):595–600. 

7. Kargbo RB. Psilocybin Therapeutic Research: The Present and Future Paradigm. ACS Med Chem Lett. 2020 Apr 9;11(4):399–402. 

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9. Corkery JM. Ibogaine as a treatment for substance misuse: Potential benefits and practical dangers. In: Progress in Brain Research [Internet]. Elsevier; 2018 [cited 2022 Nov 11]. p. 217–57. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0079612318300979

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11. Davis AK, So S, Lancelotta R, Barsuglia JP, Griffiths RR. 5-methoxy- N,N -dimethyltryptamine (5-MeO-DMT) used in a naturalistic group setting is associated with unintended improvements in depression and anxiety. Am J Drug Alcohol Abuse. 2019 Mar 4;45(2):161–9. 

12. Canady VA. FDA approves esketamine treatment for MDD, suicidal ideation. Ment Health Wkly. 2020 Aug 10;30(31):6–7. 

13. Brown E. How to Prepare for Psychedelic Therapy. MindBloom Blog [Internet]. 2021 Mar 21.

14. Pilecki B, Luoma JB, Bathje GJ, Rhea J, Narloch VF. Ethical and legal issues in psychedelic harm reduction and integration therapy. Harm Reduct J. 2021 Dec;18(1):40. 

15. Mithoefer MC. A Manual for MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder [Internet]. Multidisciplinary Association for Psychedelic Studies; 2016. 

16. Marseille E, Mitchell JM, Kahn JG. Updated cost-effectiveness of MDMA-assisted therapy for the treatment of posttraumatic stress disorder in the United States: Findings from a phase 3 trial. Yunusa I, editor. PLOS ONE. 2022 Feb 25;17(2):e0263252. 

17. Andrews T, Wright K. The frontiers of new psychedelic therapies: A survey of sociological themes and issues. Sociol Compass [Internet]. 2022 Feb [cited 2022 Nov 9];16(2). Available from: https://onlinelibrary.wiley.com/doi/10.1111/soc4.12959

18. Forstmann M, Yudkin DA, Prosser AMB, Heller SM, Crockett MJ. Transformative experience and social connectedness mediate the mood-enhancing effects of psychedelic use in naturalistic settings. Proc Natl Acad Sci. 2020 Feb 4;117(5):2338–46. 

19. George JR, Michaels TI, Sevelius J, Williams MT. The psychedelic renaissance and the limitations of a White-dominant medical framework: A call for indigenous and ethnic minority inclusion. J Psychedelic Stud. 2019 Jul 1;4(1):4–15. 

20. Ens A. Silencing indigenous pasts: critical Indigenous theory and the history of psychedelics. Int J Qual Stud Educ. 2021 Nov 26;34(10):904–14. 

21. Monson CM, Wagner AC, Mithoefer AT, Liebman RE, Feduccia AA, Jerome L, et al. MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial. Eur J Psychotraumatology. 2020 Dec 31;11(1):1840123. 

22. Thrul J, Garcia-Romeu A. Whitewashing psychedelics: racial equity in the emerging field of psychedelic-assisted mental health research and treatment. Drugs Educ Prev Policy. 2021 May 4;28(3):211–4. 

23. Tupper KW, Wood E, Yensen R, Johnson MW. Psychedelic medicine: a re-emerging therapeutic paradigm. CMAJ Can Med Assoc J. 2015 Oct 6;187(14):1054–9. 

24. Carhart-Harris RL, Roseman L, Haijen E, Erritzoe D, Watts R, Branchi I, et al. Psychedelics and the essential importance of context. J Psychopharmacol (Oxf). 2018 Jul;32(7):725–31.