Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001215314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
9/07/2026
Date registered
Help: Date registered
1/10/2026
Date last updated
Help: Date last updated
1/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
1/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Psychedelic Experiential Therapist Training: An Open-Label, Randomised, Two-Period Crossover Trial to Assess Changes to Therapist Competencies
Scientific title
Psychedelic Experiential Therapist Training: An Open-Label, Randomised, Two-Period Crossover Trial to Assess Changes to Therapist Competencies
Additional trial identifiers [1] 317330 0
Nil
Universal Trial Number (UTN)
Trial acronym
PETT-2
Related trial records

Health condition
Health condition(s) studied:
Psychedelic experiential learning for treatment of mental health conditions, for example PTSD 342070 0
Psychedelic experiential learning for treatment of mental health conditions, for example depression 343760 0
Condition category
Condition code
Mental Health 338181 338181 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is an open-label, randomised, two-period crossover trial. Participants are randomly assigned to one of two arms, which involves two modules.

Each participant completes both modules. Modules span 5 weeks, with a 2-4 week interval between modules.

Each module consists of pre-module learning (0.5-1 hour), an online preparation session (1.5-1.8 hours), followed by an in-person preparation session (1.5-1.8 hours), an in-person dosing session (8 hours), and an in-person integration session followed by an online integration session (1.5-1.8 hours).

Preparation sessions involve preparing for the dosing session, including expectations, themes, and practicalities of the experience with a co-therapy team. The dosing session is a full day during which the participant receives a single dose of psilocybin and is supported throughout by a co-therapy team. Integration sessions allow participants to discuss their experience and explore insights, themes and emotions with the co-therapy team.

Arm 1: Module 1 followed by Module 2.

Module 1 (Experiencer): Participant receives one supervised 30mg oral capsule psilocybin dosing session administered under direct supervision of a Psychedelic Assisted Therapy (PAT) mentor and study participant enrolled in Module 2 in a controlled clinical setting and four non-drug psychological support sessions (i.e. two preparation and two integration sessions).

Module 2 (Apprentice): Participant co-delivers four psychological support sessions (i.e. two preparation and two integration sessions) and psilocybin dosing sessions for another study participant (receiving 30 mg oral capsule psilocybin) alongside an experienced PAT Mentor.

Module 2 also involves an online Mentor Introduction (1 hour), two Mentor debriefs (30 mins) and Mentor Supervision (1 hour) with the PAT mentor. These sessions are designed for the participant to meet and develop rapport with their experienced PAT mentor and receive feedback as a co-therapist throughout.


Intervention code [1] 334206 0
Behaviour
Description of the comparator or control
Modules span 5 weeks, with a 2-4 week interval between modules.

Each module consists of pre-module learning (0.5-1 hour), an online preparation session (1.5-1.8 hours), followed by an in-person preparation session (1.5-1.8 hours), an in-person dosing session (8 hours), and an in-person integration session followed by an online integration session (1.5-1.8 hours).

Preparation sessions involve preparing for the dosing session, including expectations, themes, and practicalities of the experience with a co-therapy team. The dosing session is a full day during which the participant receives a single dose of psilocybin and is supported throughout by a co-therapy team. Integration sessions allow participants to discuss their experience and explore insights, themes and emotions with the co-therapy team.

Arm 2: Module 2 followed by Module 1.

Module 1 (Experiencer): Participant receives one supervised 30mg oral capsule psilocybin dosing session administered under direct supervision of a Psychedelic Assisted Therapy (PAT) mentor and study participant enrolled in Module 2 in a controlled clinical setting and four non-drug psychological support sessions (i.e. two preparation and two integration sessions).

Module 2 (Apprentice): Participant co-delivers four psychological support sessions (i.e. two preparation and two integration sessions) and psilocybin dosing sessions for another study participant (receiving 30 mg oral capsule psilocybin) alongside an experienced PAT Mentor.

Module 2 also involves an online Mentor Introduction (1 hour), two Mentor debriefs (30 mins) and Mentor Supervision (1 hour) with the PAT mentor. These sessions are designed for the participant to meet and develop rapport with their experienced PAT mentor and receive feedback as a co-therapist throughout.

Strategies for adherence include attendance to online and in-person sessions.
Control group
Active

Outcomes
Primary outcome [1] 345559 0
Psilocybin Assisted Therapist Competencies
Timepoint [1] 345559 0
Module 2 Week 6 for both Arms
Primary outcome [2] 345560 0
Psilocybin Assisted Therapist Competencies
Timepoint [2] 345560 0
Baseline, module 2 week 6, module 2 week 13, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention
Secondary outcome [1] 462160 0
Psilocybin pre-state
Timepoint [1] 462160 0
Module 1 week 4 both arms
Secondary outcome [2] 462161 0
Subjective emotional experiences during psychedelics
Timepoint [2] 462161 0
Module 1 week 4 both arms
Secondary outcome [3] 462162 0
Mystical Experiences
Timepoint [3] 462162 0
Module 1 week 4 both arms
Secondary outcome [4] 462163 0
Consciousness
Timepoint [4] 462163 0
Module 1 week 4 both arms
Secondary outcome [5] 462164 0
Acute drug experiences
Timepoint [5] 462164 0
Module 1 week 4 & week 6 for both arms
Secondary outcome [6] 462165 0
Psychological Insight
Timepoint [6] 462165 0
Module 1 week 6, week 13 for both arms
Secondary outcome [7] 462166 0
Psilocybin-occasioned challenging experiences
Timepoint [7] 462166 0
Module 1 week 4 for both arms
Secondary outcome [8] 462167 0
Challenging/meaningful experiences after psilocybin
Timepoint [8] 462167 0
Module 1 week 6 for both arms
Secondary outcome [9] 462168 0
Wellbeing
Timepoint [9] 462168 0
Baseline, week 13, 3 months after randomisation
Secondary outcome [10] 462169 0
Therapeutic alliance
Timepoint [10] 462169 0
Module 2 week 4 & week 6 for both arms
Secondary outcome [11] 463792 0
Acute drug experiences
Timepoint [11] 463792 0
Module 1 week 4 for both arms
Secondary outcome [12] 463793 0
Acute drug experiences
Timepoint [12] 463793 0
Module 1 week 6 both Arms
Secondary outcome [13] 463794 0
Therapeutic alliance
Timepoint [13] 463794 0
Module 2 week 4 & 6 for both arms
Secondary outcome [14] 466644 0
Feasability
Timepoint [14] 466644 0
Module 1 week 6, Module 2 week 6 & week 13 for both arms
Secondary outcome [15] 466650 0
Acceptibility
Timepoint [15] 466650 0
Module 1 week 6, Module 2 week 6 & week 13 for both arms

Eligibility
Key inclusion criteria
-Be aged 18 to 75 years.

-Be able to swallow capsules.

-Be a qualified mental health professional, with at least Master’s level training, and hold current, full and unrestricted registration with their respective recognised professional body.

-Be medically healthy or medically stable/well managed as determined by the study PI.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
- Have a current or lifetime history or first-degree relative of meeting DSM-5 criteria for Schizophrenia, other Psychotic Disorder, Dissociative Identity Disorder, or Bipolar I or II Disorder or other mood disorder with psychotic features.

- Have a current or past year history of meeting criteria for any DSM-5 disorder or other subclinical psychiatric symptoms, unless determined by the PI or Study Physician to be compatible with inclusion in a healthy sample.

- Have current serious suicide risk, as determined through psychiatric interview, responses to Columbia Suicide Severity Rating Scale (C-SSRS), and clinical judgment of the AP or treating team.

- Require ongoing concomitant therapy with an excluded medication.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by an independent randomisation monitor (research staff not otherwise involved in the trial)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software, stratified by age, sex assigned at birth
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321896 0
University
Name [1] 321896 0
Monash University
Country [1] 321896 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 324759 0
None
Name [1] 324759 0
Address [1] 324759 0
Country [1] 324759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320437 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 320437 0
Ethics committee country [1] 320437 0
Australia
Date submitted for ethics approval [1] 320437 0
26/11/2025
Approval date [1] 320437 0
16/02/2026
Ethics approval number [1] 320437 0
49955

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 150478 0
Dr Paul Liknaitzky
Address 150478 0
Clinical Psychedelic Lab, Monash University, Level 1, Building 2 270 Ferntree Gully Rd Notting Hill, VIC 3168
Country 150478 0
Australia
Phone 150478 0
+61 3 990 30855
Fax 150478 0
Email 150478 0
[email protected]
Contact person for public queries
Name 150479 0
Dr Paul Liknaitzky
Address 150479 0
Clinical Psychedelic Lab, Monash University, Level 1, Building 2 270 Ferntree Gully Rd Notting Hill, VIC 3168
Country 150479 0
Australia
Phone 150479 0
+61 3 990 30855
Fax 150479 0
Email 150479 0
[email protected]
Contact person for scientific queries
Name 150480 0
Dr Paul Liknaitzky
Address 150480 0
Clinical Psychedelic Lab, Monash University, Level 1, Building 2 270 Ferntree Gully Rd Notting Hill, VIC 3168
Country 150480 0
Australia
Phone 150480 0
+61 3 990 30855
Fax 150480 0
Email 150480 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.