| 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. |
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