McGill University Lady Davis Institute for Medical Research — Jewish General Hospital The ReSPCT Guidelines Reporting of Setting in Psychedelic Clinical Trials

The guidelines

The Reporting Setting in Psychedelic Clinical Trials Guidelines

The ReSPCT guidelines consist of 30 items divided into four sections. Each item should be reported in the main text or supplement of psychedelic clinical trial publications. A printable checklist and complementary explanatory document are also provided.

Printable checklist Explanatory document
  • Physical Environment
  • Dosing Session Procedure
  • Therapeutic Framework and Protocol
  • Subjective Experiences
Item Item Number Item Details
Physical Environment
Location 1 Location of the trial, and whether indoors/outdoors and urban/rural/suburban.
Ambiance 2 Room ambiance curated by the study team.
Access to nature 3 Sources of nature or natural elements accessible to participants.
Objects and decorations 4 Objects and decorations in the room.
Lighting 5 Room lighting and adjustability.
Sensory reduction 6 Sensory reduction used, such as headphones and eyeshades.
Bathroom facilities 7 Level of bathroom accessibility, privacy, and safety.
Dosing Session Procedure
Number and roles of people present 8 Number and roles of people present, including participants, study staff, and informal support.
Positioning 9 Relative position of people in the room, and what participants were positioned on.
Focus and main activities 10 Focus (internal or external) and main activities of the dosing session.
Music or soundscapes 11 Music or soundscapes that accompanied the dosing experience.
Interpersonal interventions 12 Verbal or physical interpersonal interventions used throughout the session.
Participant autonomy, control, and agency 13 Level of participant control and agency over activities and environment of the dosing session.
Dosing regimen 14 Dosing regimen, including drug dose(s), frequency, and length of the session.
Medical and experimental procedures or assessments 15 Medical and experimental procedures performed during the session.
Pre- and post-dosing protocol 16 Activities before and after dosing, including participant arrival and release conditions.
Potential disturbances or interruptions 17 Disturbances that may have impacted the dosing session.
Therapeutic Framework and Protocol
Therapeutic or guiding approach 18 Therapeutic or guiding approach used throughout the study, if any, with the accompanying manual or protocol.
Narrative framing 19 Framing of the trial intervention by the study team, including the short- and long-term drug effects.
Number of sessions 20 Number and length of preparation, dosing, and integration sessions.
Preparation protocol 21 Activities performed during the preparation sessions.
Integration protocol 22 Activities performed during the integration sessions.
Additional support or follow-up 23 Formal or informal support or follow-up offered to participants after the end of the trial, including in the case of adverse events.
Study personnel qualifications 24 The credentials, training, and expertise of personnel providing the study intervention or care.
Cultural competence and safety 25 Study team's level of cultural competence and efforts towards cultural safety.
Subjective Experiences
Therapeutic alliance 26 Therapeutic alliance between participants and facilitators throughout the intervention.
Trust 27 Participant's level of trust throughout the intervention.
Physical comfort 28 Participant's level of physical comfort during the dosing session.
Physical safety 29 Participant's sense of physical safety during the dosing session.
Psychological and cultural safety 30 Participant's sense of psychological and cultural safety with the people present during the dosing session.

Reference: Pronovost-Morgan C, Greenway KT, Roseman L & The ReSPCT Experts. An international Delphi consensus for reporting of setting in psychedelic clinical trials. Nature Medicine. 2025. https://www.nature.com/articles/s41591-025-03685-9 (doi:10.1038/s41591-025-03685-9)