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.
| 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. |
The ReSPCT Guidelines 