The Common Outcome Protocol
One shared way to measure readiness, safety, and results — so that every clinic, study group, and university studying psychedelic-assisted care is finally speaking the same language, and the whole field can learn together instead of apart.
Fractured evidence is the enemy. A shared protocol is the cure.
Right now, a hundred good-faith teams are measuring different things, in different ways, at different times. The result is a mountain of data that can't be pooled, compared, or trusted — exactly when lawmakers, regulators, and the public are deciding the future of these medicines. If we all measure the same core the same way, every veteran's experience adds to one growing, credible body of evidence.
Neutral governance & an honest conflict-of-interest firewall
A standard is only worth adopting if it can't be accused of cooking the books. So the rules come first:
- Independent stewardship. The protocol and the registry are governed by the independent, nonprofit Standards & Registry Council (psychedelic-medicine physician, toxicologist, methodologist/biostatistician, ethics/IRB member, plus veteran, patient, and caregiver representatives) — not by any product company.
- COI firewall, stated plainly. Operation Whole Health sells wellness products and helped convene this standard. Those functions are walled apart: the standards/registry arm is separate, analyses are pre-registered, methods are open, and no result is ever contingent on anyone buying anything.
- Your data stays yours. Each clinic, study group, or participant owns their record. Contribution to the shared registry is voluntary, de-identified, and portable — you can leave and take your data with you.
- Ethics first. Collecting outcomes to learn what works is human-subjects research — it requires IRB oversight and informed consent, and (for any digital record of health data) a HIPAA-compliant system with a signed BAA. This document is the measurement standard; the compliant platform is built behind those rails, not before them.
A Common Core + a per-medicine annex
Everyone collects the same minimum dataset at the same milestones, using validated instruments. Each medicine adds its own short safety annex on top (cardiac for ibogaine, serotonergic for MDMA, and so on — mapped to the Readiness Standard, Protocol v1). Low burden, high comparability.
What everyone collects, and when
| Measure | What it captures | Type |
|---|---|---|
| Cardiac screen — ECG/QTc, blood pressure, heart rate | The risk that can end everything, especially for QT-prolonging medicines like ibogaine | Safety Core |
| Medication reconciliation & interaction check | Full med list; serotonergic drugs (SSRIs/MAOIs), CYP2D6 considerations | Safety Core |
| C-SSRS — Columbia Suicide Severity Rating Scale | Suicidal ideation & behavior — the field's gold-standard safety screen | Safety Validated |
| Medical & psychiatric history / contraindications | Personal & family cardiac history, psychosis/bipolar screen, pregnancy | Core |
| Readiness index (OWH) | Whether preparation steps and understanding are in place | Adjunct |
| Measure | What it captures | Type |
|---|---|---|
| Primary condition outcome — PCL-5 (PTSD), PHQ-9 (depression), or GAD-7 (anxiety) | The main symptom target, chosen to match the person's condition | Core Validated |
| Function & disability — WHODAS 2.0 or Sheehan Disability Scale | Whether life actually works better: work, relationships, daily function | Core Validated |
| Wellbeing — WEMWBS (Warwick-Edinburgh) | The positive side — not just fewer symptoms, but more life | Adjunct Validated |
| Therapeutic alliance (baseline) | Trust with the care team — a known driver of outcomes | Adjunct |
| Measure | What it captures | Type |
|---|---|---|
| Vital signs over time; adverse-event log | Blood pressure, heart rate, temperature; anything unexpected, graded | Safety Core |
| Medicine, dose, set & setting record | Exactly what was given and under what conditions — so results are comparable | Core |
| MEQ-30 (or brief MEQ-4) — mystical-type experience | Intensity/quality of the acute experience, which tracks with outcomes | Adjunct Validated |
| CEQ (or brief CEQ-7) — challenging experience | The hard parts — fear, grief, difficulty — measured honestly | Adjunct Validated |
| EBI — Emotional Breakthrough; CADSS — dissociation | Emotional release and dissociative states during the session | Adjunct Validated |
Short, repeatable, and shared — the running pulse that turns individual journeys into learnable data. Kept deliberately brief to protect trust and reduce burden.
| Measure | What it captures | Type |
|---|---|---|
| Brief mood / sleep / craving / side-effect check | How the days are actually going, in a 60-second check-in | Core |
| C-SSRS screener (since-last-visit) | Ongoing suicide-risk safety net, with an escalation trigger | Safety Validated |
| Integration engagement | Did the practices/plans actually happen this week? | Adjunct |
| Measure | What it captures | Type |
|---|---|---|
| Repeat primary outcome (PCL-5 / PHQ-9 / GAD-7) | Did symptoms change — and does the change last? | Core Validated |
| Repeat function & wellbeing (WHODAS/SDS, WEMWBS) | Durability of real-life improvement | Core Validated |
| Adverse events & new medications | Delayed or lasting harms, including HPPD-type effects | Safety Core |
| Loss-of-diagnosis (where applicable) | The outcome that matters most to a veteran — no longer meeting criteria | Adjunct |
Both sides check in — and the questions actually move the needle
The patient and the clinician each answer a short, purpose-built check-in. Same event, two viewpoints — which is exactly what makes the data honest and useful. Any safety flag (a positive C-SSRS screen, a serious side effect) triggers an immediate escalation to the care team, never a silent data point.
🧑 Patient check-in
- How are you feeling today? (mood, 0–10)
- How did you sleep?
- Any cravings or urges? How strong?
- Any side effects or physical symptoms?
- Since we last talked, any thoughts of harming yourself? (C-SSRS screener)
- Did you do your integration practice? What came up?
- One word for today.
🩺 Clinician check-in
- Observed function & engagement since last contact
- Any adverse events? (type, severity, action taken)
- Vitals / cardiac notes where indicated
- Medication changes or interaction concerns
- Suicide-risk assessment & safety plan status
- Integration support delivered
- Clinical impression of change (better / same / worse)
Who adopts this — and how
Clinics & programs
Adopt the Common Core, keep your own records, and contribute de-identified aggregates. Certify to the standard for the OWH-Prepared seal.
Study groups & universities
Align your outcome set to the Common Core so your findings pool with everyone else's — and count toward the collective evidence base.
Clinicians & facilitators
Use the shared check-ins with your patients; earn continuing-education credit through the provider track.
Patients & veterans
Your journey, measured with care and consent, becomes part of the proof that helps the next person — and shapes fair policy.
Researchers & methodologists
Help refine the instruments and pre-register the analyses. The methodology is open by design.
Policymakers
Reference a transparent, standardized evidence base — without any endorsement of a specific substance.
To adopt the protocol, join the Standards & Registry Council, or pilot it with your program, contact michael@operationwholehealth.org or see Get involved.
Instruments are validated, not invented
- Posner K, et al. The Columbia–Suicide Severity Rating Scale: Initial Validity and Internal Consistency Findings From Three Multisite Studies. Am J Psychiatry, 2011.
- Ashbaugh AR, et al. Psychometric Validation of the English and French Versions of the PTSD Checklist for DSM-5 (PCL-5). PLoS ONE, 2016.
- Barrett FS, et al. Validation of the revised Mystical Experience Questionnaire (MEQ30) in experimental sessions with psilocybin. J Psychopharmacol, 2015.
- Strickland JC, et al. The Mystical Experience Questionnaire 4-Item (MEQ-4) and Challenging Experience Questionnaire 7-Item (CEQ-7). Psychedelic Medicine, 2024.
PHQ-9, GAD-7, WHODAS 2.0, Sheehan Disability Scale, WEMWBS, EBI, and CADSS are widely published, validated instruments; their inclusion and final versions are subject to review by the Standards & Registry Council before ratification. Instrument set verified against the peer-reviewed literature (Consensus, PubMed) — full citations to be attached at v1.0.
Operation Whole Health — Patriot-founded 501(c)(3). The Common Outcome Protocol — prototype, DRAFT v0.1, open for the field to shape. Not medical, legal, or research advice; adoption requires local IRB oversight, informed consent, and applicable data-protection compliance.
United as one movement for the future of psychedelic-assisted medicine. In crisis? Veterans Crisis Line: dial 988, then press 1.