Registering a participant for the Registry can be done following the process below.

Registering a participant for the Registry can be done following the process below.

  1. The treating clinician approaches the Registry to notify of their plan to treat someone with ketamine or PAP. This can be done via email to papregistry@anu.edu.au or via the website link here. You must obtain the patient’s consent. The referral should include the following:
  2. Patient’s full name and email address
  3. Referring doctors full name and email address
  4. Patient’s age
  5. Proposed treatment (psilocybin, MDMA, or ketamine) and indication
  6. Whether your patient has consented to be contacted by the Registry
  7. Individuals undergoing psychedelic therapy will only be providing consent to participate in the Registry; consent in regard to the delivery of ketamine or PAP will be the responsibility of the treating clinicians. Engagement in ketamine treatment or PAP will not be dependent on consenting to participate in the Registry.
  8. The referral information of the person undergoing treatment is entered into the Registry, triggering an automated email with a link to the Participant Information and Consent Form (PICF).
  9. If the participant consents, the treating clinician is emailed a link to commence the collection of the participant’s medical history, planned date/s for chosen therapy, and the short clinical global impression questionnaire (the participant will also receive a link to commence the collection of Registry data).
  10. Both the treating clinician and the participant will be sent a series of questionnaires before, during, and after their proposed treatment, with follow-up periods of 24 months for ketamine treatment and 12 months for PAP. Questionnaires for the treating clinician are very brief and collected less frequently than the participant’s questionnaires.

If you have any questions about this, you can contact the Registry at papregistry@anu.edu.au.

Communication of Results

If your patient consents, you will be sent a link via email, which will grant you access to the results of the clinical questionnaires. This can be accessed through the patient’s treatment. If you lose the link, you can contact the Registry at papregistry@anu.edu.au and we will send a new one.

Psychedelic-Assisted Psychotherapy

Participants will be asked to complete online questionnaires at multiple timepoints. For those receiving psychedelic-assisted psychotherapy with psilocybin or MDMA, the schedule of data collection is as follows:

  1. Baseline
  2. Pre-psychedelic (before 1st dosing session)
  3. Between dosing 1 and 2
  4. Between dosing 2 and 3
  5. Post-psychedelic treatment (after final dosing session)
  6. Post-final integration (after final integration session)
  7. 3-month follow up (from final integration date)
  8. 6-month follow-up (from final integration date)
  9. 9-month follow-up (from final integration date)
  10. 12-month follow-up (from final integration date)

The clinical data collected from the participant depends on the treatment they are receiving. Not all questionnaires are completed at every timepoint due to the time burden; however, they are all completed before treatment (baseline), after treatment, and at the 3-month follow up, which is congruent with the RANZCP Clinical Memorandum on the Therapeutic use of MDMA for PTSD and psilocybin for treatment-resistant depression.

MDMA (PTSD)Psilocybin (Depression)
  • Impact of Event Scale (IES-R)
  • Patient Health Questionnaire 9 (PHQ-9)
  • Generalised Anxiety Disorder Assessment 7 (GAD-7)
  • Depression, Anxiety and Stress Scale 21 (DASS-21)
  • Assessment of Quality of Life 8D (AQoL-8D)
  • Patient Health Questionnaire 9 (PHQ-9)
  • Generalised Anxiety Disorder Assessment 7 (GAD-7)
  • Depression, Anxiety and Stress Scale 21 (DASS-21)
  • Assessment of Quality of Life 8D (AQoL-8D)

Additionally, the Registry will collect other research related information, which will be useful in answering specific research questions, for example, how treatment expectations influence outcomes.

Ketamine Treatment and Ketamine-Assisted Psychotherapy

For those receiving ketamine treatment or ketamine-assisted psychotherapy, the schedule of data collection is as follows:

  1. Baseline
  2. Week 2 follow up
  3. Week 4 follow up
  4. Week 6 follow up
  5. Week 8 follow up
  6. 3-month follow up
  7. 6-month follow up
  8. 9 month follow up
  9. 12-month follow up
  10. 18 month follow up
  11. 24 month follow up

Note: all follow ups are based on the date of the first treatment.

Not all questionnaires are completed at every timepoint due to the time burden. The questionnaires used are listed below:

Ketamine (Any Indication)
  • Patient Health Questionnaire 9 (PHQ-9)
  • Generalised Anxiety Disorder Assessment 7 (GAD-7)
  • Depression, Anxiety and Stress Scale 21 (DASS-21)
  • Assessment of Quality of Life 8D (AQoL-8D)