Blossom for sponsors
The Therapy Fidelity Annex
A structured, citation-complete competency manifest for the psychotherapy component of a psychedelic trial. You choose the protocol family. We assemble the roles, the care stages, and the trial-anchored competencies that sit under them, each one tied back to the source document it came from.
When the FDA reviewed Lykos Therapeutics' MDMA application in 2024, two of the sharpest criticisms were about the therapy, not the molecule: therapy protocols that varied across sites, and thin documentation of how therapists were trained and supervised. A sponsor (the company or research group running a trial) now has to show that the psychotherapy was specified, consistent, and overseen, in the same evidentiary register as the drug itself.
That is a documentation problem, and it is the one this annex is built to help with.
What the annex is
One manifest per protocol family. You tell us which roles (for example lead therapist, co-therapist, supervisor) and which care stages (screening, preparation, dosing, integration) you need covered. We return the competencies that anchor to each, with an evidence anchor, a citation, and the underlying source document for every row. It arrives as a PDF and DOCX for your regulatory file, plus a JSON version so the same content can drive your own systems.
What a row looks like
A short excerpt from the MDMA family, for illustration. The full annex runs to every competency that anchors to the roles and care stages you select.
| Competency | Category | Care stage | Evidence anchor | Citation |
|---|---|---|---|---|
| Therapeutic boundaries, professional conduct, and consent for touch | Ethics and safety | Preparation | sop-guidebook | Yehuda et al., 2026 |
| Recognising and responding to acute distress during dosing | Crisis management | Dosing session | trial-manual | Mitchell et al., 2023 (MAPP2) |
| Holding a non-directive, inner-directed therapeutic stance | Therapeutic stance | Dosing session | treatment-manual | Mithoefer et al., 2017 |
| Screening for cardiovascular risk before MDMA administration | Medical screening | Preparation | protocol | Mitchell et al., 2021 (MAPP1) |
| Structuring integration to consolidate session material | Integration | Integration | sop-guidebook | Yehuda et al., 2026 |
Illustrative rows. Citations shown are examples of the anchoring style, not a published standard.
Where the content comes from
Every row is drawn from Blossom's living clinical guideline library: more than 130 trial-anchored documents (manuals, protocols, and guidebooks tied to real trials), refreshed weekly as new material lands. You can browse the same library the annex reads from.
Browse the guideline libraryWhat it is not
- Not regulatory advice. It is source material for your regulatory and clinical teams, not a submission written for you.
- Not an expert-reviewed standard. It is a structured reading of the public trial record. No panel has ratified it as the correct set of competencies.
- Provenance is documented per item. Every competency names its source document and anchor type, so you can check our work rather than take it on trust.
Request an annex
Each annex is prepared per engagement. Scope depends on the protocol family and how many roles and care stages you need covered, so there is no fixed price. Tell us what you are working on and we will come back with a proposal.