Clinical Research Directory

Participants wear the EmbracePlus wrist-worn biosensor (Empatica Inc.) continuously throughout all study phases: a 3-7 day pre-session baseline period, the full duration of the KAT session, and 3-5 day monitoring windows at 1, 2, and 4 weeks post-session. The device records the interbeat interval stream, electrodermal activity (phasic and tonic components), skin temperature, and accelerometry. Both the HRV and EDA channels are required for valid arc-detection output. Data is streamed via Bluetooth to a secured local device and transferred to the study data layer within 24 hours of each monitoring session. Sessions with confirmed EDA channel loss exceeding 15% of the intra-sessional recording window are flagged and excluded from primary analysis.

Participants independently arrange their own ketamine-assisted therapy sessions with a licensed physician or nurse practitioner in British Columbia or Alberta prior to enrolment. Ketamine is administered solely by the licensed treating provider under existing clinical frameworks. The researcher does not administer, possess, or dispense ketamine in connection with this study and has no clinical role during the session. All clinical decisions and participant safety oversight remain entirely with the treating provider. This exposure is observed, not researcher-administered.

A structured pre-session interview (30-45 minutes) is conducted within 48 hours before the KAT session, audio-recorded with participant consent, focusing on self-narrative and subjective state rather than trauma content. A structured post-session interview (30-45 minutes) is conducted within 4 hours of session end, mapping subjective experience to the session timeline and administering the Post-Session Subjective Integration Scale. Trauma-informed communication is used throughout. Interviews are conducted by the PI or Co-Investigator only; the right to pause or end the interview at any time is explicitly communicated to participants.