Australia authorised-psychiatrist prescribing (MDMA, psilocybin)

1. Introduction

Version followed: the regulatory frame is the TGA Checklist for prescribing psychiatrists (May 2026 revision, published June 2026) plus the RANZCP Psychedelics Training Framework v2.0 (June 2025) and Victorian Department of Health guidance (updated 24 Nov 2025). The session-level psychotherapy follows the MAPS MDMA-assisted psychotherapy manual. Sources include the 23 Oct 2010 revised teaching draft (Ruse, Mithoefer, Jerome, Doblin, Gibson) and the MAPP2 Phase 3 protocol (NCT04077437). The current manual, v8.1 of 22 Aug 2017, is not drawn on here [uncertain: wording may differ from v8.1]. For psilocybin, the RANZCP names the Yale ACT-based manual (Sloshower, Guss, Krause, 2020), but its text is not drawn on here [uncertain].

What it is. This is a regulated access pathway, not a single therapy. Since 1 July 2023, MDMA (for PTSD) and psilocybine (for treatment-resistant depression, TRD) have been Schedule 8 in the Poisons Standard for those two uses only, and only when prescribed by a specialist psychiatrist who holds TGA Authorised Prescriber (AP) approval. All other uses remain Schedule 9 and are limited to ethics-approved research. No MDMA or psilocybine product is on the ARTG, so both remain "unapproved" goods whose quality, safety and efficacy the TGA has not assessed. Each AP runs their own clinical treatment protocol, approved by an NHMRC-registered Human Research Ethics Committee (HREC). The psychotherapy model therefore varies between programmes, but the TGA expects it to be evidence-informed and aligned with published trials. [source: TGA MDMA and psilocybin pages; TGA checklist 2026; Victorian DoH; Astris Law 2026]

How change is thought to happen (MAPS model). MAPS holds that the medicine is a catalyst for psychotherapy, not the treatment itself. On this account, MDMA lowers fear and defensiveness and strengthens trust and rapport, which widens the person's window of tolerance. Trauma memories can then be revisited with emotional engagement, without overwhelm or numbing (the MAPP2 protocol calls this an "optimal arousal zone"). Healing is credited to the participant's own "inner healing intelligence", which therapists follow rather than direct. [source: MAPS manual 2010; MAPP2 protocol] For the psilocybin/TRD arm, the Yale manual uses Acceptance and Commitment Therapy (ACT) as the therapeutic frame [source: contextualscience.org listing]. Its detailed change model is not drawn on here [uncertain].

Status as of 2026. The pathway is operating. The TGA checklist was tightened in mid-2026: the psychiatrist must be physically present when the medicine is administered, and dosing sessions need a two-person team that includes a registered therapist. A law-firm summary (31 July 2026) reports, as of September 2025, about 87 patients treated with MDMA-assisted therapy and 47 with psilocybin-assisted therapy, and more than 600 therapists through recognised training. It also reports average programme charges of around A$30,000, and that DVA funding for eligible veterans with PTSD has been available since 3 Nov 2025. These are secondary figures that I have not checked against TGA data [uncertain]. This entry covers Australia only. For other jurisdictions, see the sibling tabs [uncertain: not researched here].

Your role as a psychotherapist. You may be (a) the referring or ongoing treating clinician outside the programme, or (b) a member of an AP's HREC-approved therapy team. A therapist can join the team only if they hold general registration with a relevant National Board (psychology with clinical endorsement, medicine, nursing and midwifery, or occupational therapy), have psychedelic-assisted psychotherapy within their scope of practice, and have training the psychiatrist judges adequate. Under Victorian law, psychologists, counsellors and other therapists may not administer these substances. [source: TGA checklist 2026; Victorian DoH]

2. Framework

[source: TGA checklist 2026 sections 2G–J, 5; MAPP2 protocol sections 4–5; MAPS manual 2010; Victorian DoH; TGA consumer page]

The number and spacing of medicine sessions are set by each protocol and are deliberately not described here.

Structural rules for the therapy team [source: TGA checklist 2026 section 2J]

• Ideally the same therapists attend every session.
• The whole team must be HREC-approved, and supporting therapists must be trained in evidence-informed psychedelic-assisted psychotherapy protocols.
• The psychiatrist sets the qualifications of any additional practitioners and manages the patient's overall psychotherapy.

Training and competence (AP psychiatrist) [source: TGA checklist 2026 section 2A; RANZCP Framework 2025]

• Competence is shown through prior work in a psychedelic clinical trial, or through structured supervision by an experienced AP.
• RANZCP lists 14 competencies across knowledge, safety and ethics, and hands-on training. Hands-on training includes supervised treatment of a real patient and working as part of the treating dyad.
• A "significant experiential part" of training must be delivered in person.
• CPD should include a peer-review group focused on psychedelic-assisted therapy.
• RANZCP "does not endorse any individual training program".

Site [source: TGA checklist 2026 section 2B]

• Equipment and trained staff for monitoring, resuscitation, and behavioural and medical emergencies.
• Immediate access to rescue medicines.
• Secure Schedule 8 storage and records.
• Within 15 minutes of an accredited facility with an emergency department.

State layer (Victoria example) [source: Victorian DoH 2025]

• The prescriber notifies the Department at least 7 days before prescribing or administering, and notifies again whenever details change.
• Pharmacists may not dispense to patients.
• Only authorised medical practitioners, nurses or nurse practitioners may administer.
• A drug register is required.
• Other states have their own permit rules [uncertain: not covered for NSW, QLD, WA, SA, TAS, ACT or NT; check the relevant health department].

3. Guiding principles

MAPS principles are attributed to MAPS. Regulatory principles are attributed to the TGA and RANZCP. [source: MAPS manual 2010; MAPP2 protocol section 5.1; TGA checklist 2026; RANZCP Framework 2025]

• Inner healing intelligence (MAPS). Trust the participant's own process to surface what needs attention. In practice, do not set an agenda for which memory gets worked on.
• Non-directive by default. Invite inquiry and offer suggestions as options, never as expectations. Use guidance sparingly.
• Follow, then support. Track where the person's experience is going and help them stay with it. Do not steer towards a predetermined outcome.
• Empathic presence. Stay attentive, including to nonverbal cues, during long silent stretches.
• "Don't get ahead of the medicine" (MAPS 2010). If the person is intellectualising or planning ahead, gently invite them back to direct experience.
• Accept and follow resistance. Respect it the first time. If it recurs, explore it gently and together, as information.
• Weight towards self-direction. Balance the participant's lead against therapist direction, tilted towards the participant.
• Optimal arousal zone (MAPP2). Keep trauma processing between overwhelm and dissociation, and adjust your support to stay in that band.
• Non-pathologising of unusual experience. MAPS asks therapists to treat spiritual or transpersonal experiences as meaningful to the person, without pathologising them. This is MAPS's stance, not a claim about their nature. Assess for psychosis separately.
• Multiplicity is normal. MAPS holds that inner "parts" are normal and encourages familiarity with approaches such as Internal Family Systems. Respond to parts without labelling them as pathology.
• Safety above research or programme goals (MAPS). If a safety concern conflicts with completing the protocol, safety wins.
• Consent is continuous. The person can withdraw at any time, and the withdrawal process is written into the consent form (TGA). Re-check consent before any touch.
• Touch only by prior agreement; absolutely no sexual contact (MAPS). The person's "stop" is obeyed except where touch is needed for safety, such as preventing a fall or self-harm.
• Same team, two people (TGA). Two staff attend every medicine session, ideally the same dyad throughout. Avoid substitute therapists.
• Psychiatrist accountability (TGA). Screening, written consent and overall management of the psychotherapy stay with the AP. Escalate to them; do not decide eligibility yourself.
• No access outside supervision (TGA). Never handle, hold or arrange the substance outside the supervised session.
• Therapist self-knowledge and boundaries (MAPS). You need comfort with intense emotion and healthy boundaries. MAPS also recommends therapists have their own experience of non-ordinary states, for example through holotropic breathwork. That is MAPS's recommendation, not a TGA requirement.
• Cultural safety and privacy (RANZCP). Adapt the setting, language and support-person arrangements to the person's culture, and protect their records.
• Transparency about status (TGA). Tell patients plainly that the product is unapproved, what it costs, and what ARTG-registered alternatives exist.

4. Intervention inventory

Interventions are grouped by phase. Items marked [synthesis] are my guidance for an Australian psychotherapist and are not taken from a named manual. MAPS items come from the 2010 teaching draft [source: MAPS manual 2010]. All example language is illustrative unless quoted.

A. Outside-programme referral assessment (referring psychotherapist)

• Purpose: Decide whether to raise the AP pathway with a client who has PTSD or TRD, and prepare a useful referral. [synthesis, built on TGA eligibility rules]
• Steps:
  1. Confirm a documented diagnosis (PTSD or TRD) and list prior treatments, including medications tried and evidence-based psychotherapies, with their duration and response. The AP has to document that ARTG-registered options failed (the TGA checklist suggests at least two pharmacological ones).
  2. Screen in general terms for features protocols commonly exclude: psychotic or bipolar I disorders, dissociative identity disorder, eating disorder with purging, some personality disorders, significant substance-use disorder, current serious suicide or violence risk, cardiovascular disease, uncontrolled hypertension, liver disease, pregnancy or breastfeeding, and lack of social support or likely re-exposure to the trauma. Do not decide eligibility; flag these for the psychiatrist. [source: MAPP2 exclusion criteria; RANZCP Framework]
  3. Explain the realities: the medicine is unapproved, costs are high (reported around A$30,000; veterans may have DVA funding), places are limited, it is not available by telehealth or to take home, and other treatments remain available.
  4. Write to the GP or AP with a summary of diagnosis, treatment history, risk, current supports, and your willingness to continue care and share information (with consent).
• Example language (illustrative): "This pathway exists, but it's narrow. A psychiatrist approved by the TGA decides whether you're eligible, and it's costly. I can help you put together your treatment history so that conversation is useful."
• Watch for: Clients pinning all hope on the pathway, or planning to use outside the scheme if refused (see 4.Z). Also watch for clinics that advertise the medicine directly; Schedule 8 medicines may not be advertised to the public [source: Astris Law 2026].

B. Psychiatrist screening and baseline assessment (AP; team supports)

• Purpose: Establish eligibility and stratify risk. The TGA requires the psychiatrist to do all screening personally.
• Steps:
  1. The psychiatrist reviews psychiatric and medical history, contraindications, special populations (pregnancy, older people) and conditions such as psychosis, mania, substance use and physical illness [source: RANZCP Framework competencies 7, 11].
  2. Baseline outcome measures are taken. RANZCP's suggested scales are used, or the protocol justifies alternatives [source: TGA checklist 2E]. Name the instruments your protocol specifies.
  3. The psychiatrist reviews current medicines, which may need adjusting [source: RANZCP Framework competency 8]. This is a medical decision; the therapist only notes adherence or distress and relays it.
  4. Suicide risk is assessed with a structured instrument. MAPP2 used the Columbia Suicide Severity Rating Scale (C-SSRS) at baseline and around every session [source: MAPP2]. Items are not reproduced here.
  5. The person names a support contact who can be reached if they become suicidal or unreachable [source: MAPP2].
• Example language (illustrative): "Before anything else, Dr X will go through your physical and mental health in detail. Some conditions make this treatment unsafe, and we'd rather find that out now."
• Watch for: Pressure to minimise symptoms or medical history in order to qualify, and over-reliance on remote screening (non-face-to-face screening must be justified).

C. Informed consent process

• Purpose: Valid initial and ongoing consent, led by the psychiatrist [source: TGA checklist 2H].
• Steps:
  1. Cover the purpose of treatment and what taking part involves.
  2. Cover the risks of the medicine and the risks during sessions.
  3. Include a financial consent statement.
  4. Include a declaration that the product is unapproved, not on the ARTG, and not assessed by the TGA.
  5. Get explicit, documented consent to any video recording.
  6. Describe the withdrawal process.
  7. Discuss physical touch before treatment [source: RANZCP].
  8. Tell the person in advance about crisis options: daily meetings until stable or, as a last resort, hospital [source: MAPS 2010].
  9. Revisit consent at each phase.
• Example language (illustrative): "You can stop at any point, including partway through the programme, and your other care continues."
• Watch for: Signs the person doesn't understand (ask them to explain it back in their own words), and consent given under financial or hope-driven pressure.

D. Alliance-building and history (preparation)

• Purpose: MAPS treats a solid alliance as an absolute prerequisite before any medicine session.
• Steps:
  1. Both therapists meet the person. MAPS invites therapists to share something of their own background and why they do this work.
  2. Take a history of symptoms, trauma, prior treatments, medical and psychiatric history, and prior experience with psychedelics or other altered states.
  3. Use the same dyad from the start (TGA).
• Example language (illustrative): "We'll be the two people with you through every part of this, so it matters that you can tell us when something doesn't feel right with us."
• Watch for: Whether the person can disagree with you and ask for things. If they can't, keep preparing before going further.

E. Orientation and expectation-setting

• Purpose: Prepare the person for what a session involves, and for the likelihood that trauma material and PTSD symptoms will surface.
• Steps:
  1. Describe the room, the eyeshades and music, the alternation between going inward and talking, the presence of both therapists, and the aftercare arrangements.
  2. Explain that both pleasant experiences and early confrontation with traumatic memories are part of the process, and that affirming experiences may come later.
  3. Explain that effects continue to unfold for days afterwards.
  4. Hold intentions lightly [source: MAPS 2010].
• Example language (illustrative): "Some people meet the hardest memory early on; others feel calm and connected first. Neither one means it's going right or wrong."
• Watch for: Rigid expectations, such as "I'll be cured" or "I must relive X". Loosen them gently.

F. Naming and normalising fears

• Purpose: Reduce anticipatory fear. MAPS lists common fears: the unknown, changing identity, and flashbacks.
• Steps:
  1. Ask directly what the person is afraid of.
  2. Normalise the fear as expected.
  3. Link it to the safety agreements and the coping skills you will teach.
• Example language (illustrative): "What's the thing you're most worried might happen in there?"
• Watch for: Fear of losing control may be a marker of significant trauma. Leave more preparation time.

G. Diaphragmatic breathing, two uses

• Purpose: MAPS teaches abdominal breathing (1) for relaxation if anxiety comes up early, and (2) for "breathing into" difficult feelings so the person stays present instead of distancing.
• Steps:
  1. Teach slow abdominal breathing in preparation and practise it in session.
  2. Rehearse the second use: notice where a feeling sits in the body, and breathe towards it.
  3. Agree a short cue you will use during the session.
• Example language (illustrative): "Let the breath go down to where that tightness is, without trying to push it away."
• Watch for: Hyperventilation or effortful breathing. Slow the pace and keep it gentle.

H. Support network and disclosure planning

• Purpose: Arrange support for after the session and manage the risk of judgement from others.
• Steps:
  1. Map who the person can rely on.
  2. Decide together whom to tell, and what to say about the treatment.
  3. Encourage discretion [source: MAPS 2010].
  4. If a partner or support person is to be involved, the team first assesses whether they can be supportive without being directive.
• Example language (illustrative): "Who will be around in the week afterwards, and what do you want them to know?"
• Watch for: Isolation or unstable relationships. Lack of social support is a common protocol exclusion [source: MAPP2].

I. Safety and touch agreements

• Purpose: Explicit agreements made before any altered state.
• Steps:
  1. Agree what nurturing touch the person consents to, such as hand-holding.
  2. Agree whether focused bodywork may be offered.
  3. State the absolute commitment to no sexual contact.
  4. Agree the "stop" rule: the therapist complies unless touch is needed for safety.
  5. Ask how close the therapists should sit.
  6. The person agrees not to harm themselves or others or damage property, and to comply with requests to stop dangerous behaviour.
  7. Record all agreements, and re-confirm them on the day [source: MAPS 2010; RANZCP].
• Example language (illustrative): "If you say stop, we stop. The only exception is if you're about to fall or hurt yourself."
• Watch for: Ambivalent consent to touch. Default to no touch and revisit later. Trauma involving touch may call for a no-touch plan [synthesis].

J. Preparing the setting

• Purpose: A safe, non-clinical-feeling room [source: MAPS 2010; TGA checklist 2B].
• Steps:
  1. Furnish the room like a private living room: blankets, temperature control, art and flowers, a rest area, food and drink, and art supplies.
  2. Keep safety and monitoring equipment and the emergency plan available but unobtrusive. They are the medical team's domain.
  3. Prepare eyeshades, headphones and a pre-selected, mostly instrumental music programme. MAPS avoids lyrics to minimise suggestion.
  4. Tell the person they can ask for silence or take off the eyeshades or headphones at any time.
• Watch for: Room features that are cultural or trauma triggers (lighting, locked doors, gender of staff). Adjust in preparation [synthesis].

K. Opening the medicine session

• Purpose: Re-establish the frame.
• Steps:
  1. Review the approach, the agreements and any concerns.
  2. Reinforce the non-directive stance.
  3. Confirm the support plan for the end of the day.
  4. The AP psychiatrist must be physically present for administration, and all handling of the medicine stays with medical or nursing staff [source: TGA checklist 2J; Victorian DoH].
• Example language (illustrative): "Our job today is mostly to keep you company and keep you safe. You lead; we'll follow."
• Watch for: Last-minute ambivalence. The person may withdraw without penalty.

L. Alternating inner focus and dialogue

• Purpose: Let material emerge, then process it together [source: MAPS 2010].
• Steps:
  1. Encourage periods of inward focus with eyeshades and music. During these, therapists keep a quiet, empathic presence.
  2. When the person speaks or surfaces, listen actively and reflect.
  3. If the person has been silent for a long time, check in briefly.
  4. The balance between inner focus and talking varies, and is often roughly equal.
• Example language (illustrative): "You've been quiet a while. Anything you'd like to say, or would you rather keep going inside?"
• Watch for: Long silences masking distress or dissociation, and talking used as a way of avoiding inner experience.

M. Stepwise response to distress that blocks processing

• Purpose: MAPS describes a graded sequence. Move to the next step only if the previous one hasn't helped.
• Steps:
  1. Ask what the person notices in their body, and encourage breathing into it.
  2. Encourage them to stay present and go inside.
  3. If they are agitated, offer gentle physical reassurance they have consented to.
  4. Ask whether images, memories or thoughts are arising, and explore them if they are.
  5. Gently invite a return to inner experience.
  6. If physical tension or distress persists, consider focused bodywork (see O).
  • Throughout, reassure them that they are safe and this is part of healing, and welcome tears, sounds and other expression.
• Example language (illustrative): "Stay with it if you can. Where is it in your body right now?" / "You're safe here; this is what we prepared for."
• Watch for: Movement out of the optimal arousal zone, in either direction: into flooding (escalating panic) or into shutdown (flat, absent). Medical signs are flagged to the medical team at once.

N. Nurturing touch

• Purpose: Grounding and reassurance, only within the agreements made beforehand [source: MAPS 2010; RANZCP].
• Steps:
  1. Offer, don't impose.
  2. Use the agreed forms of touch only, such as a hand held or a hand on the shoulder.
  3. Re-check consent in the moment.
  4. Stop immediately on "stop".
  5. Document all touch [synthesis on documentation; recording if consented, TGA 2H].
• Example language (illustrative): "Would it help if I held your hand, like we talked about?"
• Watch for: Compliance rather than genuine wish. Altered states heighten suggestibility and attachment, so keep touch minimal and visible to both team members [synthesis]. Any sexualised behaviour by either party ends the touch; respond as in section 5.

O. Focused bodywork (MAPS)

• Purpose: MAPS describes focused bodywork as a last-resort catalyst for persistent physical tension, pain or distress. It requires prior consent and the "stop" rule applies.
• Steps: The detailed procedure is in a MAPS appendix not drawn on here [uncertain]. Do not improvise it. Use it only if your HREC protocol includes it and you have been trained in it.
• Watch for: Re-traumatisation through touch. Consider leaving it out for survivors of interpersonal violence unless it has been explicitly negotiated [synthesis].

P. Working with resistance and intellectualising

• Purpose: Respect defences while inviting deeper contact [source: MAPS 2010].
• Steps:
  1. The first time, accept and follow the resistance.
  2. If it recurs, offer choices rather than directions: to say more, or to try not distracting themselves.
  3. If the person is analysing, gently redirect them inward.
• Example language: "Don't get ahead of the medicine." (MAPS 2010, verbatim) / "Would you like to say more about that, or let it be for now?" (illustrative)
• Watch for: Pushing past a "no". That is a consent breach, not therapy.

Q. Working with dissociation and parts

• Purpose: MAPS treats derealisation and depersonalisation as layers of defence to be explored gently, and treats inner parts as normal (IFS-informed) [source: MAPS 2010].
• Steps:
  1. Invite the person to notice the experience rather than push through it.
  2. Ground them with breath, an orienting question or consented touch.
  3. If a "part" appears (a frightened part, a critical part), get curious about it and its role, without labelling it as pathology.
• Example language (illustrative): "Can you notice the part of you that's stepping back right now? What is it worried would happen if it didn't?"
• Watch for: Sustained, unresponsive dissociation. Bring in the medical team and use grounding, and do not deepen the work [synthesis]. The MAPS manual does not give a full IFS procedure; detailed IFS steps belong to IFS training [uncertain].

R. Accepting unusual or transpersonal experience

• Purpose: MAPS asks therapists to receive spiritual or transpersonal experiences as meaningful to the person, without pathologising them. This is MAPS's stance; it makes no claim about what such experiences are.
• Steps:
  1. Reflect the experience in the person's own words.
  2. Avoid interpreting it in any one framework.
  3. Bring it into integration.
• Example language (illustrative): "That sounds like it mattered a lot. Tell me what it was like."
• Watch for: Persistent psychotic features or manic symptoms after the session. These are clinical concerns for the psychiatrist, not material for spiritual framing.

S. Closing the session, aftercare and the overnight stay

• Purpose: Safe transition out of the altered state [source: MAPS 2010; MAPP2].
• Steps:
  1. Before discharge, the team reviews physiological stability, self-reported distress and mental state.
  2. Explain that effects continue to unfold for days.
  3. Encourage writing, art and recording dreams, and review relaxation and self-soothing skills.
  4. A support person may join at the end if this was assessed in advance.
  5. In MAPS trials, the person stayed overnight in a private room with a nurse attendant who listens quietly and attends to physical needs (attendants do not act as therapists). Therapists remained reachable by phone, and the person did not drive until after the next-morning session.
  6. The AP protocol defines local arrangements.
• Example language (illustrative): "Over the next few days, things may keep surfacing, in dreams or memories or emotions. Jot them down; we'll look at them together."
• Watch for: Anyone leaving unstable, and anyone without the planned support at home.

T. Next-morning integration session

• Purpose: Early processing and a safety check. MAPP2 held a session of about 90 minutes the morning after.
• Steps:
  1. Invite a narrative of the session.
  2. Note themes, body sensations and emotions.
  3. Validate both difficult and positive material.
  4. Re-check suicide risk with the protocol's instrument.
  5. Confirm the plan for check-ins.
  6. Content beyond this is not detailed in the sources [uncertain]; the rest of this item is [synthesis].
• Example language (illustrative): "What stands out this morning? Anything that surprised you, or is still sitting with you?"
• Watch for: Shame about what was said or done in session, or a sense of having been exposed. Normalise it, and revisit confidentiality.

U. Check-in calls

• Purpose: Monitor safety and keep contact in the days after. MAPP2 called every other day for 14 days; the 2010 manual describes daily contact for about a week.
• Steps:
  1. Keep calls brief.
  2. Ask about sleep, mood, intrusive material, suicidal thinking (with the structured instrument if the protocol requires it), and use of coping skills.
  3. Escalate to the AP as needed.
• Example language (illustrative): "How have you been sleeping, and has anything come up that's been hard to manage?"
• Watch for: A delayed dip in mood or a surge in symptoms, and missed calls. Use the named support contact if the person can't be reached [source: MAPP2].

V. Further integrative sessions

• Purpose: Consolidate meaning and translate insight into daily life. MAPP2 held further non-drug integrative sessions after each medicine session, including one shortly before any next medicine session. Their content is not described in the documents [uncertain].
• Steps [synthesis]:
  1. Review dreams, journals and art.
  2. Connect session material to current symptoms and relationships.
  3. Process trauma memories that came up, using your existing trauma-therapy skills within the window of tolerance.
  4. Identify changes the person wants to make.
  5. Plan how the next session's intention will be held lightly, and note new concerns for the psychiatrist.
• Example language (illustrative): "You said you felt, for the first time, it wasn't your fault. Where has that shown up, or not, this week?"
• Watch for: Insights that don't translate into change, and idealising the experience or the team.

W. Psilocybin for TRD: ACT-informed preparation and integration (Yale manual)

• Purpose: RANZCP lists the Yale manual (Sloshower, Guss, Krause, 2020), which uses ACT as the frame for psilocybin-assisted therapy of depression.
• Steps: the manual's session-by-session content is not drawn on here [uncertain]. If your AP protocol adopts it, follow that manual directly. As a general [synthesis] of standard ACT, outside the manual: in preparation, clarify values and practise present-moment awareness and willingness towards difficult inner experience. In integration, use defusion from depressive self-stories and link insights to values-based committed action. The overall session frame (team, setting, consent, monitoring) is the same TGA frame as above.
• Example language (illustrative): "What would you want to be moving towards, if depression weren't calling the shots?"
• Watch for: Rumination about the experience. Treat it as a thought to notice, not a puzzle to solve [synthesis].

X. Outcome monitoring, completion and long-term follow-up

• Purpose: Required by the TGA protocol [source: TGA checklist 2E; RANZCP competencies 8, 14].
• Steps:
  1. Administer the protocol's rating scales and quality-of-life measures at the times it specifies.
  2. Apply its definition of completion.
  3. Contribute data to the RANZCP framework for recording safety and quality, and to the long-term follow-up the protocol specifies (registry or outsourced service, with consent).
  4. Agree with the AP who provides ongoing psychotherapy after the programme ends.
• Watch for: Losing the person to follow-up after the programme. Arrange the handover to their usual clinician before discharge [synthesis].

Y. Recording, adherence review and peer review

• Purpose: Quality and safety.
• Steps:
  1. Record sessions only with explicit, documented consent [source: TGA 2H].
  2. MAPS trials used blinded adherence raters to score randomly selected preparatory, medicine and integration sessions against manual criteria [source: MAPP2 5.4].
  3. RANZCP recommends a psychedelic-assisted therapy peer-review group as part of CPD.
  4. Use recordings in supervision [synthesis].
• Watch for: Drift away from the protocol, and therapist fatigue during long sessions.

Z. Harm-reduction and integration support for clients using outside the scheme [synthesis]

• Purpose: Many clients will be ineligible, or will use outside the AP pathway (retreats overseas, underground use). Your role is assessment, safety planning, general risk education and integration. It is never facilitation.
• Steps:
  1. Ask non-judgementally about plans and past use.
  2. Assess psychiatric and medical risk factors (the same conditions protocols exclude).
  3. Tell the person in general terms that interactions with psychiatric and other medicines can be dangerous, that substances from illegal markets are of unknown content, and that a medical review is advisable. Do not advise on dosing, sourcing, combinations or tapering.
  4. Build a safety plan: a sober support person, crisis numbers (Lifeline 13 11 14; Suicide Call Back Service 1300 659 467), and an agreement to seek urgent care for medical or psychiatric emergencies.
  5. Offer integration sessions afterwards, and refer to the legal pathway or a psychiatrist where appropriate.
  6. Document your role carefully.
• Example language (illustrative): "I can't help you get or use it, but I can help you think through the risks and be here afterwards."
• Watch for: Being drawn into facilitation (being present during use, recommending a source or provider). Seek professional indemnity and legal advice if you are unsure.

5. Handling problems

Sourced items are tagged. Everything else is [synthesis].

• "Nothing happened", or the person is stuck on the surface. MAPS says affirming or deeper experiences may arrive later in a session or in later sessions, and that intentions should be held lightly [source: MAPS 2010]. In integration, look at small shifts (in the body, in relationships, in dreams) rather than the dramatic ones. Never suggest the medicine "failed" because the person resisted. [synthesis]
• Resistance and intellectualising. Accept and follow it at first. If it recurs, explore it together and offer choices [source: MAPS 2010]. Outside sessions, treat persistent guardedness as a sign the alliance or safety work is incomplete, and do more preparation [synthesis].
• Overwhelm, anxiety or panic in session. Use the graded sequence: breathing, then reassurance, then touch the person has consented to, then exploring what is arising (4.M). Medical assessment and any rescue medicine are the medical team's responsibility; MAPS describes rescue medicine as a rare last resort. After a severe panic reaction, MAPS suggests the team may consider continuing, if the person is willing, so they can work through its causes rather than learn to avoid them [source: MAPS 2010]. That decision belongs to the AP.
• Destabilisation after a session. MAPS options are daily meetings until the person is stable and, as a last resort, hospital admission. Both are disclosed at consent [source: MAPS 2010]. For a referring therapist: increase contact, tell the AP team immediately, and check sleep, safety and supports [synthesis].
• Suicidal thinking. Follow standard structured risk assessment and safety planning (MAPP2 used the C-SSRS at fixed points and named a support contact) [source: MAPP2]. Include lethal-means counselling about storage and removal, and escalate to the AP and crisis services the same day where risk is raised. Serious current risk excludes a person from medicine sessions; a past attempt alone did not in MAPP2.
• An exclusion criterion appears mid-programme (for example, manic symptoms, pregnancy, or new medical illness). Medicine sessions stop, but integration continues [source: MAPP2]. Present this as care, not punishment. [synthesis]
• Non-adherence.
  • Missed preparation or integration sessions: pause before the next medicine session and review readiness with the AP [synthesis].
  • Unreported medicine changes, or substance use outside the programme: tell the AP promptly, because interactions are a medical safety issue. Don't give interaction advice yourself [synthesis].
  • Breaking the no-driving or support-person plan: review it and, if it repeats, raise suitability with the AP [synthesis].
• Ruptures.
  • Touch-related (touch that felt unwanted, or a refusal that felt like rejection): name it, apologise for any misattunement, go back over the agreements, and default to less touch [synthesis].
  • Feeling abandoned when a therapist leaves the room: MAPS keeps at least one therapist present at all times [source: MAPS 2010].
  • Conflict within the dyad: debrief outside sessions and take it to supervision [synthesis].
• Boundary violations or sexual misconduct (not addressed in the RANZCP framework). Altered states increase suggestibility and dependence. Keep both team members present, keep touch visible, record sessions where consent allows, and never have contact outside the protocol. If a client discloses misconduct by any practitioner, support them, document their account, and check your notification obligations under the Health Practitioner Regulation National Law with Ahpra, and your HREC and AP reporting lines. [synthesis; uncertain: specific notification thresholds not checked here]
• Disappointment after a costly programme, or idealising the programme. Prepare the person beforehand by stating plainly that the product is unapproved, that results vary, and that ARTG-registered alternatives exist [source: TGA 2H]. Afterwards, grieve the expected cure with them, and keep other evidence-based treatments on the table [synthesis].
• Experiences framed as spiritual or as revelations. Respect the person's meaning (MAPS stance), while screening for psychosis, mania and functional decline. Only the clinical concerns go to the psychiatrist [synthesis].
• Litigation, or ongoing exposure to the trauma. MAPP2 excluded ongoing PTSD-related litigation and likely re-exposure [source: MAPP2]. Flag these before referral. If the person is in active danger, safety and stabilisation come first [synthesis].
• Ineligible client intending to use outside the scheme. Use the harm-reduction role in 4.Z. Do not facilitate, and stay available for integration [synthesis].
• The referring therapist is left out of the loop. Get consent at referral for two-way information sharing, and agree who provides psychotherapy after the programme (the AP manages the overall psychotherapy during it) [source: TGA 2J; synthesis].
• Adverse events. The AP is responsible for managing adverse events, and the protocol must describe how risks are managed [source: TGA 2F, 2I]. The checklist did not set out TGA adverse-event reporting timelines for APs [uncertain]. Team members report every adverse event to the AP straight away and document it [synthesis].
• Public advertising, or a clinic implying it can guarantee access. Schedule 8 medicines may not be advertised to the public [source: Astris Law 2026]. Report concerns to the TGA [synthesis].
• Regulations change. The TGA checklist has been revised several times (2023, Feb 2025, May–June 2026). Before acting, check the current TGA, RANZCP and state pages [synthesis].

Sources

Sources:

• MDMA and psilocybin (TGA)
• From 1 July 2023, specialist authorised psychiatrists can access MDMA and psilocybine (TGA consumer page)
• Prescribe MDMA or psilocybine: psychiatrists (TGA)
• Checklist for prescribing psychiatrists of psychedelics (TGA, May 2026, published June 2026)
• Psychedelics Training Framework v2.0 (RANZCP, June 2025)
• Schedule 8 MDMA and Schedule 8 psilocybine (Victorian Department of Health, updated 24 Nov 2025)
• MDMA-Assisted Psychotherapy Treatment Manual landing page (MAPS)
• MDMA-assisted psychotherapy treatment manual, revised draft 23 Oct 2010 (MAPS)
• MAPP2 Phase 3 protocol, NCT04077437 (ClinicalTrials.gov)
• Psilocybin-Assisted Therapy of Depression using ACT (Yale Manual) listing (ACBS)
• Becoming an Authorised Prescriber of MDMA or Psilocybin (Astris Law, 31 July 2026; secondary)

Further reading (not drawn on) [uncertain]:

• Mithoefer, M., Mithoefer, A., Jerome, L., Ruse, J., Doblin, R., Gibson, E., Ot'alora G., M., Sola, E. (2017). A Manual for MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder, v8.1. MAPS.
• Sloshower, J., Guss, J., Krause, R. (2020). The Yale Manual for Psilocybin-Assisted Therapy of Depression (using Acceptance and Commitment Therapy as a therapeutic frame). PsyArXiv preprint.
• Phelps, J. (2017). Developing guidelines and competencies for the training of psychedelic therapists. Journal of Humanistic Psychology.
• TGA guidance Access to MDMA and psilocybin for therapeutic purposes: information for psychiatrist prescribers.