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Mind Medicine Australia 2021 Mental Health Super Summit Nigel Denning
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Mind Medicine Australia

Dec 11, 2021

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Page 1: Mind Medicine Australia

Mind Medicine Australia

2021 Mental Health Super SummitNigel Denning

Page 2: Mind Medicine Australia

www.mindmedicineaustralia.orgwww.cpat.mindmedicineaustralia.org

Acknowledgement of Country

We recognize the continuous and deep connection to Country, of Aboriginal and Torres Straight Islander peoples, as the first people of this nation.

In this way, we respectfully acknowledge the traditional custodians of the land, the sea, waters and sky.

We invite you to tune into a body of water, mountain or land space that is scared to you and feel deeply into your connection to this Country. Honoring with gratitude and humility the privilege of being on this Country.

It is an honor to be teaching on Country and we hope our work supports the sacred connection to this place.

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Disclaimer

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Mind Medicine Australia does not encourage or facilitate illegal use of psychedelics or plant medicines. Our focus is wholly clinical.

Mind Medicine Australia reserves the right to record and publish webinars on various social media platforms.

You agree that you will not discuss any names, locations or specific details of illegal use of psychedelics both verbally or via any written forms of communication via Mind Medicine Australia social media platforms (for

example Facebook, Instagram and zoom private and public chat forms during the webinar).

We thank you for your support and cooperation on these matters.

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Who is Mind Medicine ?

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Purpose of Mind Medicine Australia

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• Mind Medicine Australia (MMA) is a charity that helps to alleviate the suffering caused by mental illness in Australia through expanding the treatment options available to medical practitioners and their patients. We are establishing safe and effective psychedelic-assisted treatments to cure a range of mental illnesses. Founded by Tania de Jong AM and Peter Hunt AM.

• Primary current focus on medicinal psilocybin (for Depression) and medicinal MDMA (for PTSD) Psychotherapies. Also interested in other psychedelic medicines including ketamine, ibogaine and DMT.

• Indications of success:• These therapies become an integral part of our Mental Health System;• Achieving high remission rates leading to a substantial improvement in our Mental Health

Statistics;• And accessible and affordable to all Australians in need.

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Why is PAT needed?

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• The most common mental illnesses are: Post-Traumatic Stress Disorder (PTSD), Other Anxiety Disorders, Depression and Substance use Disorders*Impact before recent bushfires and current COVID-19 pandemicAustralian Bureau of Statistics 2018, National Health Survey First Results, cat. no. 4364.0.55.001, ABS, CanberraPsychWatch Australia, April 2019 with information from Department of Human Services, CanberraAustralian Bureau of Statistics 2009, National Survey of Mental Health and Wellbeing: Summary of Results, 4326.0, 2007. ABS: Canberra.

1 in 5 Australian adults (4.8 million people) have a chronic mental illness

Over 45% of Australians will experience mental illness in their lifetime

1 in 8 Australians are now on anti-depressants including 1 in 4 older Australians(18% increase in last 5 years95% increase in last 15 years)1 in 30 children on antidepressants as young as 4 years of age

Mental Illness Now at Alarming Levels and Getting Worse*

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Treatment Outcomes Remain Inadequate

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• There has been no improvement in treatment outcomes over the past 50 years.

• Depression: Only 35% of sufferers experience remission from pharmacotherapy (primarily anti-depressants) or psychotherapy.• 40 - 60% show some response but most experience continuing symptoms - and between

50 - 80% relapse after treatment stops.• Common side-effects of anti-depressants include insomnia, psychosis, blurred vision,

dry mouth, fatigue, GI distress, weight gain, nausea and sexual dysfunction.

• PTSD: Only 20 - 30% of sufferers show some response to pharmacotherapy and only about 50% respond to any treatments. Remission rates as low as 5%.

Holmes et al (2018) and Cuijpers (2017)De Maat et al (2006) Relative efficacy of psychotherapy and pharmacotherapy in the treatment of depression: A meta analysis 16(5): 566-578

Judd, L. L. (1997). The clinical course of unipolar major depressive disorders. Archives of General Psychiatry, 54(11), 989.

A “more of the same approach” is not going to solve the problem.

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Expanding the Medical Treatment Options

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• Primary focus on two broad types of medicine-assisted psychotherapies based on strong clinical evidence:

1. Medicinal psilocybin for depression and possibly OCD and addiction.2. Medicinal MDMA for PTSD and possibly the treatment of addiction.

• Only 2-3 dosed sessions in contrast to conventional treatments (involving daily medications and/or weekly psychotherapy).

• Medicine are ‘curative’ not palliative.

• Very safe in a medically controlled environment and non-addictive.

• With both being granted “Breakthrough Therapy Designation” by the Food and Drug Administration (FDA) in the United States to fast-track the approval process.

Johnson, M et al. (following 2014). 5-HT2AR agonist psilocybin in the treatment of tobacco addiction. Journal of Psychopharmacology, 28-11:983-992.Ross et al. (2016). Rapid and sustained symptom reduction psilocybin treatment for anxiety and depression…. Journal of Psychopharmacology, 30-12:1165-1180.

Carhart-Harris et al. (2016). Psilocybin with psychological support for treatment-resistant depression. The Lancet, 3-7:619-627.

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Treating the Cause: Medicinal Psilocybin Assisted-Psychotherapy for Depression

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Psilocybin Placebo

Increased communication between brain networks (based on fMRI scans)

Alters communication between brain networks, such as the Default Mode Network (DMN), which are associated with many mental illnesses.

Enabling patients to ‘break out’ of repetitive and rigid styles of thinking, feeling and behaving.

Promotes a form of “active coping”, restoring patient agency.

Schenberg, E. E. S. (2018). Psychedelic-assisted psychotherapy… Frontiers in pharmacology, 9, 733.Petri, G., et al(2014). Homological scaffolds of brain functional networks. Journal of The Royal Society Interface, 11(101), 20140873.

Source: Beckley Foundation, United Kingdom Based on clinical trials at Imperial College, London

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MAPS Phase 3 Trial Results (2021)The Nature Medicine Journal (May 2021) highlights the ground-breaking MAPS’ Phase 3 trial results.• The highly statistically significant results and excellent safety record suggest MDMA-assisted therapy

will be an effective treatment for severe, chronic PTSD. • 67% of participants who received three MDMA-assisted therapy sessions no longer qualified for a

PTSD diagnosis and 88% experienced a clinically meaningful reduction in symptoms.• The pivotal Phase 3 trial treated 90 patients with severe, chronic PTSD from any cause with an average

duration of 14 years and replicated the results of Phase 2 trials.• Study participants included patients with PTSD caused by combat-related events; accidents; abuse; and

sexual harm; 84% have a history of developmental trauma. (Mitchell, J.M., Bogenschutz, M., Lilienstein, A. et al. 2021).

Imperial College Trial Results (2021)Results published in one of the world’s top medical journals (The New England Journal of Medicine) demonstrate that two sessions of psilocybin-assisted psychotherapy were as effective in treating moderate to severe depression over the course of six weeks as daily intake of SSRI antidepressants combined with psychotherapy.• Additionally, remission rates were twice as high in the psilocybin group as in the antidepressant group.• Psilocybin had quicker effects and was of greater magnitude in reducing depressive symptoms.• Additionally, those who received psilocybin reported far fewer side effects and feelings of anxiety and

suicidal ideation were also reduced significantly. (Carhart-Harris et al., 2021).

Results that are Building Momentum

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Delivering Outstanding Trial Results

12Griffiths, R. R. et al. (2016). Psilocybin produces substantial and sustained decreases in depression and anxiety … Journal of psychopharmacology, 30(12), 1181-1197.

# At least 50% reduction in symptoms

# Remission rates with psilocybin-assisted psychotherapy improve over time.

A graph showing the percentage of participants who improved on measures of depression and anxiety, at five weeks and six months, in a Johns Hopkins study.

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Treating the Cause: Medicinal MDMA Psychotherapy for PTSD

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MDMA is not ecstasy. Substances sold illegally often have adulterants and are often taken in risky settings with higher doses.

Decreases fear and defensiveness while increasing empathy, trust and safety.

Not therapy by itself but a catalyst for the therapeutic process.

Decreases the activity of the amygdala -associated with traumatic memory.

In a MAPS Phase 2 trial there were 105 participants, all with treatment resistant PTSD (who on average had PTSD for 18 years), led to remission in 52% of cases immediately and in 68% at the 12 month follow up.

Phase 3 trial taking place at 15 research sites in the U.S., Canada, and Israel. Interim analysis of the data revealed 90% or greater probability that there will be statistically significant results when all participants have been treated. MDMA is likely to be prescribable in 18 months in USA.

Mithoefer, M. C., Feduccia, A. A., Jerome, L., Mithoefer, A., Wagner, M., Walsh, Z., ... & Doblin, R. (2019). MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology, 1-11.

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www.mindmedicineaustralia.orgwww.cpat.mindmedicineaustralia.org

What Are Psychedelics?

Psychedelic

Hallucinogen

Entheogen

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www.mindmedicineaustralia.orgwww.cpat.mindmedicineaustralia.org

From a pharmacological perspective, psychedelics may be categorized firstly by their function:

The 'Classical' Psychedelic Hallucinogens:• LSD• Psilocybin• Dimethlytryptamine• Mescaline

Categories

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www.mindmedicineaustralia.orgwww.cpat.mindmedicineaustralia.org

The Entactogen or Empathogen • MDMA• MDA 2-CB 2C-I 2C-T-7

The NMDA-antagonist Dissociative • Ketamine • PCP • DXM

Categories

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www.mindmedicineaustralia.orgwww.cpat.mindmedicineaustralia.org

The Kappa-Opioid Agonist Dissociative

Categories

• Ibogaine

• Salvia Divinorum

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www.mindmedicineaustralia.orgwww.cpat.mindmedicineaustralia.org

Risk

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Trial Protocols

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Protocols

There are three types of trial protocols currently either underway or having been published in recent years:

1. Neurological based protocols.

2. Protocols that utilise supportive therapy.

3. Protocols that employ psychological therapy.

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o The Imperial College London has been very active in developing treatment protocols utilising psilocybin for treatment resistant depression.

o The protocol is quite specific in introducing a minimal amount of supportive counselling with psychoeducational introduction and preparation for session and two supportive counselling sessions following the treatment after each of two psilocybin sessions during treatment.

o The protocol is constructed around two preparation sessions, two psychedelic session sand three integration sessions.

o The strength of this protocol is that it really tries to focus attention on the effect of psilocybin on depression.

Protocols

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Protocols

o The protocol follows a detailed map of neurobiology and by limiting the influence of potentially confounding variables such as a

psychotherapeutic input.

o Extremely large effect sizes of d = 2.2 and 2.3 were found at weeks 1 and 5 post treatment. Effect sizes remained large at 3- and 6-

month post treatment but had waned somewhat (d = 1.5 and d = 1.4 respectively) (Carhart-Harris et al., 2016).

The treatment model for their trial is represented above, psychotherapeutic support is kept to a minimum.

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The Maps protocol for MDMA treatment of PTSD is an up to 20-session model which focusses on the need for supportive

counselling prior during and after medicine sessions.

The study comprises of the following:

o Two preparatory sessions,

o Two treatment sessions,

o Four integration sessions,

o Two research sessions, B

o Between 6-8 psychotherapy sessions,

and 2 follow up sessions.

Note: As MDMA is an empathogen rather than a psychedelic, its mechanisms of

action are somewhat different to psychedelics as is the treatment effect.

o MDMA is far less likely to elicit significant hallucinatory effects and is it

common for there to be more interaction between the patient and therapist

during these sessions.

o The MAPS protocol follows humanistic theory to support the idea of

supportive therapy.

Protocols

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The foundation for this therapeutic approach was laid by

Stan and Christina Grof, Leo Zeff, George Greer, Requa

Tolbert, Ralph Metzner, and many others [8, 14-17].

o The basic premise of this treatment approach is that

the therapeutic effect is not due simply to the

physiological effects of the medicine.

o Rather, it is the result of an interaction between the

effects of the medicine, the therapeutic setting and the

mindsets of the participant and the therapists (MAPS,

2015, p.5).

Protocols

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Figure 1. The ACT hexagon on which the Yale trials are based is outlined above.

The Yale model for PAT for depression utilises

Acceptance and Commitment Therapy (ACT) as

its treatment modality.

o In the preamble to their protocol manual,

they mention that several theoretical models

were considered before settling on ACT as

the preferred option.

o They then settled on the adoption of ACT as

the treatment modality for their trials of

psylocibin with treatment resistant

depression.

The Yale Model for Psychedelic Assisted-Therapy

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The ACT model provides a pre-session assessment followed by treatment then psychoeducation, debriefing and follow up.

o All up they allow for 20-30 hours of treatment which includes two psychedelic sessions.

o Their treatment approach is somewhat critical of the non-directive model favoured by MAPS and drawn from earlier work in psychedelic therapy.

o They suggest that the notion of an inner healing potential is insufficiently clear to base a model on, thus they privilege the use of ACT.

The Acceptance Therapy Model in the Context of PAT

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Mind Medicine Treatment Model

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Mind Medicine Australia Summary of Treatment Model

Referral (30 minutes)

Intake (60-90 minutes)

Assessment (2-3 x 90 Minutes)

Therapeutic preparation sessions (up to 3 x 60 minutes)

Psychedelic session (allow 8 hours)

Follow up therapeutic integration sessions (2-4 by 60 minutes)

Repeat Psychedelic session (allow 8 hours)

Repeat therapeutic integration sessions (2-4 by 60 minutes)

Concluding session (60-90 minutes)

Follow up (6-months, 12-months, 2-years, x 60 minutes)

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Patients being referred for PAT are likely to have been unsuccessfully treated with

other methods prior to contacting the clinic such as PTSD (Mithoeffer, xxx) or

depression (Carhart-Harris).

o They may also be facing existential crises that are typically not managed under

other treatment protocols, such as end-of-life process (Grob, 2007).

o Referral documentation from medical, psychiatric, or psychological referrers

should be assessed ahead of time wherever possible and suitable case

consultation pursued by the intake worker prior to an intake assessment where

possible or feasible.

Referral (30 minutes)

Understanding the Referral Process

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Intake (60-90 minutes)

Stage 2: Intake

The literature demonstrates considerable variation in terms of how patients coming into Psychedelic Assisted Therapy

treatment are assessed. Part of this is due to the small size of highly specific clinical studies seeking to assess very specific

issues that comprise the body of extant literature. This manual has in focus a more general clinical structure for this work

where treatment is provided in clinics rather than as research trials. Whether trial or clinic, there are very clear details that

should be derived from intake:

o Identifying information

o Reason for referral

o Chief complaint

o Medications

o Allergies

o Experience with or understanding of medicine work and PAT

The focus at this juncture is upon establishing the groundwork for an understanding of the life narrative of the patient. This will build through the whole intake and assessment process.

The Process of Intake

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There are clear exclusion criteria that should be outlined. Although

intake should screen some unsuitable candidates, a more formal

interview will render more detailed information from which to make a

clinical assessment.

o Clear exclusion will include significant psychiatric disorders such as

schizophrenia or bi-polar disorder, pregnancy, heart disease,

glaucoma, epilepsy and other significant medical treatments.

o Consideration should also be given to patients reporting significant

psychotropic medication use.

o If no reasons for exclusion arise and the patient is seen as fit for PAT,

then the process should then move to formal assessment.

Intake (60-90 minutes)

The Process of Intake

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Intake (60-90 minutes)

A simple screening instrument should be applied at the assessment stage of

any Psychedelic Assisted Therapy. Assessment tools and psychometric

instruments will be introduced and explained at this point. For example:Patient History Questionnaire Yes No

1. Do you have a history of, or currently suffer from any of the following?

a. Cardiovascular disease, including heart attacks

b. High blood pressure

c. Severe mental illness

d. Recent surgery

e. Past or recent physical injuries, including fractures or dislocations

f. Recent or current infectious or communicable diseases

g. Glaucoma

h. Retinal detachment

i. Epilepsy

j. Osteoporosis

2. Asthma (if “Yes,” please bring your inhaler to the workshop)

3. Are you currently pregnant? 4. Have you ever been hospitalized for medical reasons?

5. Have you ever been psychiatrically hospitalized? 6 . Are you currently in therapy or involved in any type of support group? 7. Are you currently taking any type of medication? 8. Were there any complications at your birth? e.g., Caesarean section/Anaesthesia

9. Is there anything else about your physical or emotional status of which we should be aware?

Conditions such as heart disease, cerebral vascular disease,

psychotic illness, and use of certain medications will be an

absolute contraindication to use of, or access to, Psychedelic

Assisted Therapy.

o Conditions such as asthma, and other low-risk medications

may be a relative contraindication.

o The ability to discern the impact of clinical syndromes on the

safety of Psychedelic Assisted Therapy must rest with a

medically trained physician able to ensure a full and complete

history, examinations and investigations related to patient care.

critical incidence and emergency in Psychedelic-Assisted

Therapy are obvious concerns and assessment should be

focused on mediating the likelihood of such events.

o Little data exists regarding critical incidence in PAT to date

probably due to the small number of highly controlled studies.

The Process of Intake

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Stage 3: Assessment

The assessment process involves pre-interview psychometric evaluation followed by a 90-minute clinical interview

with potentially subsequent psychometric evaluation based on the first interview, the interview should develop key

factors emerging from intake data, whilst also developing rapport. It is important that Psychedelic Assisted Therapy

include biological Psychological and socio-cultural factors in the assessment.

➢ First Assessment Session

o At a minimum, a 90-minute interview is recommended with

psychometric instruments provided prior to session, and

further instruments issued post-session depending according

to clinical need.o Standard preliminary assessment tools should include

assessment of mood and affect, substance use, trauma.

The Assessment Phase

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Psychometric measures for Depression tools

• DASS21

• Beck Depression and Anxiety Inventories

• Young Schema Questionnaire and a substance abuse scale

• AUDIT

• PCL V for trauma (civilian version unless otherwise specified), should render sufficient general information.

• C-SSRS is a standard measure of suicidality and should be utilised

Standard preliminary assessment tools should include assessment of mood and affect, substance use, trauma.

o Standard forms such include the following:

The Assessment Phase

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Replacement measures should be implemented with due consideration to their utility. After the preliminary assessment session more focused

psychometric tools may be administered as are most relevant to the patient’s particular presentation. Below is a list of some potential tests

currently employed in trials:Psychometric measures tools for Psychedelic Assisted Therapy

For a detailed assessment of PTSD the CAPS V is the gold standard and should be used in most instances. It can be somewhat time consuming with

administration taking between 45 and 60 minutes.

The LEC-5 is a measure that should be utilised with the CAPS V particularly for complex trauma as it allows the clinician to identify various life events.

DDIS, the Dissociative Disorders Interview Schedule allows for a more detailed assessment of trauma based dissociative conditions.

The AUDIT and DUDIT are drug and alcohol disorders check lists and should be considered as a routine aspect of intake.

The MINI or Mini International Neuropsychiatric Interview is a clinical screening tool that can help quickly generate observations of psychiatric functioning.

The MEQ or Mystical Experiences Questionnaire is a measure of transcendent experience, which is often hypothesised as the active principle in therapeutic

change.

The Assessment Phase

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This first assessment session is important as it derives both quantitative and qualitative data about the patient and their

suitability for, and likely success with, Psychedelic-Assisted Therapy. It is critical to develop good clinical data early to

help conceptualise and develop a clinical rationale for Psychedelic Assisted Therapy.

➢ However, clinicians should not lose sight of the importance of maintaining a strong collaborative relationship with the

patient as this constitutes the beginning of a therapeutic relationship and that the principles of collaboration and support

shall be, in this and the following sessions.

A more detailed case history will also be required at this point:

• History of present illness

• Past psychiatric history/substance abuse history

• Past medical history Family history

• Developmental/social history

The Assessment Phase

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The Second Assessment Session

The second assessment session, if necessary, is oriented towards further information gathering:

o It provides an opportunity to provide feedback to client and to discuss suitability for PAT. This will be

done skillfully and sensitively.

o If for some reason the patient is deemed unsuitable, then they should be offered other referral options for

support. They should also be very clearly advised as to why they are deemed unsuitable for treatment.

A second assessment session may not always be necessary and there should be some clinical judgment

applied here. The purpose of this session is to garner further detailed information and allow follow up to any

issues arising from the assessment process.

The Assessment Phase

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Stage 4: Therapeutic Preparation SessionsPsychedelic Assisted treatment will often be time-limited; however, it is essential that there has been sufficient time to meet with

the patient and develop rapport before proceeding to medicine use.

The therapeutic preparation session will involve:

o developing rapport,

o targeting therapeutic outcome goals,

o and developing a strong collaborative relationship.

Note: This may take between 1-5 sessions depending on clinical and pragmatic considerations.

Preparing for Therapy

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Preparatory sessions are essential in preparing for psychedelic sessions for the following:

1. They build the therapeutic relationship.

2. They help exclude unsuitable participants who may have got through the initial screening process.

3. The allow the therapist to prepare the patient for the range of phenomena that could arise in session.

4. Discuss processes that might be employed during a session and gauge client’s attitudes as part of the ongoing assessment.

➢ Working with the patient in preparatory sessions allows the therapist and the patient to get to know each other and develop a

sense of trust.

o Developing trust with the patient can help clinicians in screening hyper arousal, which can lead to considerable discomfort

if a patient begins to struggle against the effect of the psychedelic.

o Therefore, trusting relationship can facilitate a deepening of this experience.

Stage 4: Therapeutic Preparatory Sessions

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During introductory sessions it is important that the patient be assessed for suitability and ensure that any past experiences such

as drug psychosis or other psychotic phenomena, violence, addiction, or other considerations are explored. Non-disclosure of

psychological or medical history can have serious consequences for sessions and can put the patient and the program itself at

risk.

o There are an almost infinite range of experiences that can emerge during a psychedelic session.

o If one is unfamiliar with the content it can cause significant reactivity such as flight, fight, or freeze responses (Canon,

1915).

o The more prepared the patient is and the more trusting of both the process and the therapists, the more likely this will

resolve in situ.

The details of in session content will be discussed in

the next section.

Stage 4: Therapeutic Preparatory Sessions

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Treatment

Prior to the first substance session, a 60-90 min psycho-educational session

is required that addresses all practical matters: including time, place,

suitable clothing, food, hydration etcetera. The patient should be presented

with a form that outlines all the practical aspects of their session. This

might include:

• Substance information

• Dosage as per protocols

• Related risks

• Set and setting information.

• Consent forms (to be signed and returned)

Stage 5: Preparation Session for Psychedelic

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The Importance of Pre-substance Sessions

As previously stated, pre-substance sessions are of critical importance for several reasons, these include:

1. The therapist’s developing an understanding of the unique subjectivity of the patient.

2. The therapist’s developing an understanding the unique nature of the patient’s presenting problem.

3. The creation of a collaborative relationship between therapist and patient, concerning the presenting problem and its

aetiology.

4. The establishment of trust and safety between patient and therapists, as a way of maximising the benefits derivable from the

therapeutic sessions.

5. Understanding the role of touch in PAT which is always negotiated beforehand and touch is offered as a possibility not a

necessity and always in service to the patient.

6. The beginning of training in mentalising practice

Stage 5: Preparation Session for Psychedelic

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Stage 6: The Psychedelic Session Itself

Experimental Session Initial Dose Supplemental Dose* Min-Max Cumulative Dose

1 80 mg 40 mg 80 mg to 120 mg2 80 or 120* mg 40 or 60 mg 80 mg to 180 mg3 80 or 120* mg 40 or 60 mg 80 mg to 180 mgTotal Cumulative Dose 240 mg to 480 mg* Unless contraindicated

Psilocybin (see Beckley and Compass Pathways)Experimental Session Initial Dose Supplemental Dose Min-Max Cumulative Dose

1 10 mg - 10 mg2 25 mg - 25 mgTotal Cumulative Dose 35 mg

Lets Talk About Dosage

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o A full day should be allowed for the psychedelic-assisted treatment session itself. This will vary as per medication, dosage,

and treatment presentation, however, sufficient time should always be allowed for the session, given its results will be highly

subject to the patient responses.

o Standard recommendations for dosages of psylocibin and MDMA are presented in the section headed dosage, however, PAT

utilising ketamine or similar anaesthetics require careful understanding of dosage; risks should be considered when using this

type of PAT.

As discussed earlier, it is recommended that there should always be two therapists present for the duration of a psychedelic-

assisted therapy session.

o One of these therapists should have prescription rights. Ideally it would be a male/female dyad though we understand that

this is not always pragmatic. There may be some instances too, where it is inappropriate, for instance if the patient has a

strong gender-based trauma history and cannot down regulate adequately.

Stage 6: The Psychedelic Session Itself

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Allowing time is critical in the structuring of the psychedelic assisted session.

o The varieties of substances used in PAT have highly variant periods of action.

o The clinician needs to plan sessions with half-life of substance in mind but a with a full awareness that individuals can react

in a variety of ways to the psychedelic experience as a whole.

o LSD has a longer action time than psylocibin by several hours, for instance.

o The substance use should never be medically administered by the therapist but should rather be provided to the patient for

self-administration, with attention to mind set at the time of ingestion.

o This allows for the patient to maintain a sense of control through the setting which enhances the experience of a supportive

and collaborative environment.

o Activation generally takes 40-60 minutes. This constitutes an entry period. During this time, it is important that the

therapeutic dyad be focussed on the support and comfort of the patient entering the state change process.

Stage 6: The Psychedelic Session Itself

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The use of eye-masks is recommended; however, this depends upon the psychedelic substance which is being used. When using

MDMA for instance, there may be a desire for more relational engagement through the process.

Several important related topics to be considered in the psychedelic session include:

• Music

• Non-intervention, therapists focus.

• Altered state process.

• Keeping the patient comfortable.

• Always support if they need to go to the bathroom.

Stage 6: The Psychedelic Session Itself

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There is a plethora of complex phenomenal events that can emerge in Psychedelic Assisted Therapy that lie

outside the realm of everyday presentations. These may take the form of as by way of example:

• Blocks

• Regressions

• Disruptions in motility (somatic manifestations)

• Alternations to experiences of spatiality, temporality

• Imagery

• Sound distortions

Stage 6: The Psychedelic Session Itself

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Intervention and interrogation of the experience, should be avoided unless indicated by the patient.

o Intervention in the persons experience in any form needs to be clearly appraised. verbal or physical (by very light touch)

intervention into experience should be done at an absolute minimum.

o As the patient exits the experience of safety is the central priority.

o A clear assessment of their cognitive, affective and sensate experience should be made.

o Gentle exploration of aspects of unresolved tension throughout the body should be explored with the permission of the

patient, based on preparatory agreements.

Stage 6: The Psychedelic Session Itself

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The patient should be checked on by a member of the treatment team with whom they are familiar the next morning for any

residual effects of the medication.

Upon exiting the altered state Phase 1 integration should be employed:

o Phase one integration can involve artwork, diarising or some other free and creative method of marking experience.

o Artwork can provide a non-invasive way to begin the integration process upon exiting the altered state.

o The therapist may, for instance, provide an A3 white sheet of quality artist’s paper with a circle drawn through its centre to

allow the patient to create “mandala” symbolic form of representation of their experience as Mandala.

Stage 6: The Psychedelic Session Itself and Patient care

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Assessing Safety Post-Session

It is important to ensure that the patient is feeling fully grounded and clear, with no physiological or emotional material lingering

from the session.

o It is best to have a lounge or some comfortable area where they can sit and become present even if they have spent some time

on artwork and have spoken to the therapist about their session.

o They should be checked fully for any residual symptoms such as accelerated heart rate, dissociated phenomena, dizziness etc.

o Driving is contra-indicated after a session so they should have a way to get home safely that has been pre-arranged.Taxi, Uber,

friend, relative.

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Stage 7: Repeat of stages 5, 6, 7

This constitutes the second medicine session and follows the general pattern of the lead-up, administration and integration of

the first session. Any issues that arose in session 1 should be discussed and resolved.

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While psychedelic integration has become a buzzword in psychedelic communities, it remains somewhat

vaguely conceived, undertheorized, and, in general, longs for an operational relationship to the problem

being treated. It often centres a non-specific mixture of supportive listening and encouragement to engage

in introspective practices, such as journaling, meditation, and spending time in nature. (Yale manual 1.10)

Stages of Integration

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1. First stage: Re-constitution

The pre-narrative stage in which the patient is slowly reorganising and reordering their self-concept and perceptions. Useful

interventions in this stage are artwork such as the formal mandala activity in which a session is represented within a circle

drawn the size of a dinner plate in the centre of an A3 sheet. This structure provides some containment and some direction

but allows also free flow of representation.

It should be clearly stated that there is no expectation of skill in art on display, that it is purely representative of their

personal experience and is intended to be a symbolic representation of this experience.

o Another stage one integration method is free form journaling. This should not take any structured form at this stage so no

detailed instructions about what to write should be provided. The patient should be free to simply jot down whatever

comes to mind regarding their experience.

Stages of Integration

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A third option is simply to verbalise to their therapist in a non-formal manner.

o At this point the therapist should not engage in any discourse around the experience but should rather be a supportive

listener allowing the patient to reorganise at their own pace.

2. Second stage: Stabilise the view.

This involves a more structured balance between narrativization and stabilisation of view through meta-cognitive attention to

relevant post-formal perception and awareness. This is critical in the first 4 to 7 days post dose.

3. Third stage: Total narrative integration

This occurs after the first week and moves into a narrating stance, where there is attention to paid to meaning making and

integration of the experience and the view attained. In this stage mentalising practice becomes a function of the therapeutic

relationship and the therapist is encouraged to help the patient construct meaning of their experience at the level of thought,

affect, sensation, memory and relationship.

Stages of Integration

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This is perhaps the single most significant aspect of PAT work, particularly in the integration phases but

should be established in the preparation and maintained throughout the treatment. We will discuss

mentalisation and its product, metacognition, in detail shortly.

o The ability for a patient to exit the work having integrated experience when successful, means that they

will have an approved ability to perceive patterns of self-functioning, or what are described as schemata

though with slightly varying uses (Young, DiMaggio, Piaget).

o Patients may be able to understand the genesis of emotions, sensations, symptoms or diagnoses.

o They may be able to read their body responses more successfully or their bodily responses to other based

on their new understanding deeply set patterns (Sui & Humphreys, 2015).

Mentalisation Skills in Post-Psychedelic Integration

Sessions

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Stage 9: Concluding Sessions

A third phase integration session would involve a consideration of the patient’s global experience of PAT and a narrativisation of

the self in relation to that experience. We will detail this in the sections under mentalisation and metacognition. Any follow up

referral should be made in this session.

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Stage 10: Follow up

Psychometric tools should be administered if that has previously been agreed upon and is part of the treatment design. Patient

welfare and progress should be checked at intervals following cessation.

➢ Ideally at 6, 12 and 26 weeks. Research follow up should continue annually for 24 months to assess longer term change.

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