{
  "instrument_name": "Psychedelic Experience Registry Observational Instrument",
  "short_name": "PER-OI",
  "version": "2.1.0",
  "status": "research-prototype-pending-IRB-review",
  "design_principles": [
    "nonclinical observational registry",
    "participant may use platform without research consent",
    "one participant can contribute multiple episodes",
    "one episode can contain multiple reported exposures",
    "acute effects separated from later outcomes",
    "adverse/safety events have a dedicated module",
    "validated copyrighted scales are referenced, not reproduced"
  ],
  "timepoints": [
    {
      "code": "baseline",
      "timing": "once initially and refresh periodically"
    },
    {
      "code": "pre",
      "timing": "before an anticipated experience, when participant chooses"
    },
    {
      "code": "acute",
      "timing": "after the acute experience when participant is able to reflect safely"
    },
    {
      "code": "fu_24h",
      "timing": "approximately 24 hours"
    },
    {
      "code": "fu_7d",
      "timing": "approximately 7 days"
    },
    {
      "code": "fu_30d",
      "timing": "approximately 30 days"
    },
    {
      "code": "fu_90d",
      "timing": "approximately 90 days"
    },
    {
      "code": "fu_180d",
      "timing": "approximately 180 days, optional"
    },
    {
      "code": "fu_365d",
      "timing": "approximately 365 days, optional"
    }
  ],
  "modules": {
    "eligibility_and_consent": [
      {
        "id": "EC01",
        "type": "boolean",
        "label": "I am 18 years of age or older.",
        "required": true
      },
      {
        "id": "EC02",
        "type": "boolean",
        "label": "I understand this registry does not provide medical care, individualized medical advice, dosing advice, or legal advice.",
        "required": true
      },
      {
        "id": "EC03",
        "type": "boolean",
        "label": "I understand I may use the personal logging features without consenting to research use.",
        "required": true
      },
      {
        "id": "EC04",
        "type": "boolean",
        "label": "I voluntarily agree that eligible de-identified records may be used for the research described in the approved consent document.",
        "research_only": true
      },
      {
        "id": "EC05",
        "type": "boolean",
        "label": "I understand that research permission can be withdrawn prospectively through the registry.",
        "research_only": true
      }
    ],
    "baseline": [
      {
        "id": "BL01",
        "type": "choice",
        "label": "Age range",
        "options": [
          "18–20",
          "21–24",
          "25–34",
          "35–44",
          "45–54",
          "55–64",
          "65+",
          "Prefer not to answer"
        ]
      },
      {
        "id": "BL02",
        "type": "choice",
        "label": "Gender identity",
        "options": [
          "Woman",
          "Man",
          "Nonbinary / gender diverse",
          "Self-describe",
          "Prefer not to answer"
        ]
      },
      {
        "id": "BL03",
        "type": "choice",
        "label": "Sex assigned at birth",
        "options": [
          "Female",
          "Male",
          "Intersex / another designation",
          "Prefer not to answer"
        ]
      },
      {
        "id": "BL04",
        "type": "multiselect",
        "label": "Race/ethnicity (select all that apply)",
        "options": [
          "American Indian or Alaska Native",
          "Asian",
          "Black or African American",
          "Hispanic or Latino/a/x",
          "Middle Eastern or North African",
          "Native Hawaiian or Other Pacific Islander",
          "White",
          "Another identity",
          "Prefer not to answer"
        ]
      },
      {
        "id": "BL05",
        "type": "text_short",
        "label": "Country of residence",
        "privacy": "country only"
      },
      {
        "id": "BL06",
        "type": "text_short",
        "label": "State/region of residence",
        "privacy": "do not collect street address"
      },
      {
        "id": "BL07",
        "type": "choice",
        "label": "Highest education completed",
        "options": [
          "Less than high school",
          "High school/GED",
          "Some college/technical",
          "Associate degree",
          "Bachelor’s degree",
          "Graduate/professional degree",
          "Prefer not to answer"
        ]
      },
      {
        "id": "BL08",
        "type": "choice",
        "label": "Current work/school status",
        "options": [
          "Employed full-time",
          "Employed part-time",
          "Student",
          "Unemployed/seeking work",
          "Not currently working",
          "Retired",
          "Other",
          "Prefer not to answer"
        ]
      },
      {
        "id": "BL09",
        "type": "choice",
        "label": "Approximate number of prior psychedelic/dissociative experiences",
        "options": [
          "0",
          "1",
          "2–5",
          "6–10",
          "11–20",
          "21+",
          "Unsure"
        ]
      },
      {
        "id": "BL10",
        "type": "boolean_optional",
        "label": "Have you previously had an experience you considered severely difficult or destabilizing?"
      },
      {
        "id": "BL11",
        "type": "boolean_optional",
        "label": "Are you currently receiving mental-health care?"
      },
      {
        "id": "BL12",
        "type": "boolean_optional",
        "label": "Are you currently taking one or more prescription medications?"
      },
      {
        "id": "BL13",
        "type": "multiselect",
        "label": "Self-reported history (optional; not a diagnosis by this registry)",
        "options": [
          "Depressive disorder",
          "Anxiety disorder",
          "Trauma-related disorder",
          "Bipolar-spectrum disorder",
          "Psychotic-spectrum disorder",
          "Substance-use disorder",
          "ADHD",
          "Autism spectrum",
          "Other",
          "None reported",
          "Prefer not to answer"
        ]
      },
      {
        "id": "BL14",
        "type": "scale_0_10",
        "label": "Overall wellbeing today"
      },
      {
        "id": "BL15",
        "type": "scale_0_10",
        "label": "Overall emotional distress today"
      },
      {
        "id": "BL16",
        "type": "scale_0_10",
        "label": "Sleep quality during the past 7 days"
      },
      {
        "id": "BL17",
        "type": "boolean_optional",
        "label": "Have you experienced a major life stressor recently?"
      }
    ],
    "episode_identification": [
      {
        "id": "EP01",
        "type": "choice",
        "label": "Is this record prospective or retrospective?",
        "options": [
          "I am documenting before the experience",
          "The experience already occurred"
        ]
      },
      {
        "id": "EP02",
        "type": "date_precision",
        "label": "Approximate date of experience",
        "privacy": "allow exact date, month, year, or unknown"
      },
      {
        "id": "EP03",
        "type": "choice",
        "label": "How certain are you about the substance identity?",
        "options": [
          "Substance was independently tested",
          "Based on labeled/source information",
          "Based on my own belief/report",
          "Unknown"
        ]
      },
      {
        "id": "EP04",
        "type": "repeat_group",
        "label": "Reported substances/exposures",
        "fields": [
          "substance class",
          "substance name",
          "route category",
          "amount if participant chooses",
          "unit",
          "amount uncertain",
          "relative timing"
        ]
      },
      {
        "id": "EP05",
        "type": "repeat_group",
        "label": "Other substances used around the same period (optional)",
        "fields": [
          "broad category",
          "name if known",
          "relative timing"
        ]
      },
      {
        "id": "EP06",
        "type": "choice",
        "label": "Primary broad substance class",
        "options": [
          "Classic serotonergic psychedelic",
          "Entactogen/empathogen",
          "Dissociative",
          "Iboga-type/oneirogen",
          "Salvia/kappa-opioid",
          "Other/mixed/unknown"
        ]
      }
    ],
    "pre_experience": [
      {
        "id": "PR01",
        "type": "multiselect",
        "label": "Reasons or intentions for the experience",
        "options": [
          "Curiosity/exploration",
          "Personal growth",
          "Emotional processing",
          "Spiritual/religious purpose",
          "Creativity",
          "Social/recreational",
          "Self-directed mental-health purpose",
          "Pain/physical symptom purpose",
          "Other",
          "Prefer not to answer"
        ]
      },
      {
        "id": "PR02",
        "type": "text_long",
        "label": "Describe your intention in your own words (optional)"
      },
      {
        "id": "PR03",
        "type": "scale_-5_5",
        "label": "Overall expectation: from very negative to very positive"
      },
      {
        "id": "PR04",
        "type": "scale_0_10",
        "label": "How strong are your expectations about what will happen?"
      },
      {
        "id": "PR05",
        "type": "scale_0_10",
        "label": "Anxiety immediately beforehand"
      },
      {
        "id": "PR06",
        "type": "scale_0_10",
        "label": "Mood immediately beforehand"
      },
      {
        "id": "PR07",
        "type": "scale_0_10",
        "label": "Physical wellbeing immediately beforehand"
      },
      {
        "id": "PR08",
        "type": "number_optional",
        "label": "Approximate hours slept the prior night"
      },
      {
        "id": "PR09",
        "type": "choice",
        "label": "General setting",
        "options": [
          "Private residence",
          "Outdoor/nature setting",
          "Ceremonial/religious setting",
          "Retreat setting",
          "Entertainment/social venue",
          "Clinical/research setting",
          "Other",
          "Prefer not to answer"
        ]
      },
      {
        "id": "PR10",
        "type": "scale_0_10",
        "label": "How familiar/comfortable is the setting?"
      },
      {
        "id": "PR11",
        "type": "choice",
        "label": "Social context",
        "options": [
          "Alone",
          "One other person",
          "Small group",
          "Large group",
          "Facilitated/ceremonial group",
          "Clinical/research staff present",
          "Other"
        ]
      },
      {
        "id": "PR12",
        "type": "boolean_optional",
        "label": "Was a trusted support person expected to be available?"
      },
      {
        "id": "PR13",
        "type": "choice_optional",
        "label": "Support person's general role",
        "options": [
          "Friend/partner/family",
          "Peer supporter",
          "Ceremonial/spiritual facilitator",
          "Licensed health professional",
          "Research staff",
          "Other"
        ]
      },
      {
        "id": "PR14",
        "type": "boolean_optional",
        "label": "Was there a plan for obtaining emergency help if needed?"
      },
      {
        "id": "PR15",
        "type": "scale_0_10",
        "label": "How interpersonally safe did you feel in the setting?"
      },
      {
        "id": "PR16",
        "type": "scale_0_10",
        "label": "How concerned were you about legal consequences?"
      }
    ],
    "acute_experience": [
      {
        "id": "AC01",
        "type": "scale_0_10",
        "label": "Overall intensity"
      },
      {
        "id": "AC02",
        "type": "scale_0_10",
        "label": "Overall positive emotional tone"
      },
      {
        "id": "AC03",
        "type": "scale_0_10",
        "label": "Overall negative emotional tone"
      },
      {
        "id": "AC04",
        "type": "scale_0_10",
        "label": "Fear"
      },
      {
        "id": "AC05",
        "type": "scale_0_10",
        "label": "Confusion"
      },
      {
        "id": "AC06",
        "type": "scale_0_10",
        "label": "Sense of losing control"
      },
      {
        "id": "AC07",
        "type": "scale_0_10",
        "label": "Connectedness to other people or the world"
      },
      {
        "id": "AC08",
        "type": "scale_0_10",
        "label": "Awe or wonder"
      },
      {
        "id": "AC09",
        "type": "scale_0_10",
        "label": "Insight or new understanding"
      },
      {
        "id": "AC10",
        "type": "scale_0_10",
        "label": "Alteration in usual sense of self"
      },
      {
        "id": "AC11",
        "type": "scale_0_10",
        "label": "Alteration in sense of time"
      },
      {
        "id": "AC12",
        "type": "scale_0_10",
        "label": "Alteration in perception"
      },
      {
        "id": "AC13",
        "type": "scale_0_10",
        "label": "Emotional breakthrough/release"
      },
      {
        "id": "AC14",
        "type": "scale_0_10",
        "label": "Overall difficulty/challenge"
      },
      {
        "id": "AC15",
        "type": "scale_0_10",
        "label": "Personal meaningfulness"
      },
      {
        "id": "AC16",
        "type": "scale_0_10",
        "label": "Spiritual significance, if applicable"
      },
      {
        "id": "AC17",
        "type": "text_long",
        "label": "Experience narrative"
      },
      {
        "id": "AC18",
        "type": "text_long",
        "label": "Helpful, positive, or meaningful events"
      },
      {
        "id": "AC19",
        "type": "text_long",
        "label": "Difficult, frightening, or unexpected events"
      }
    ],
    "safety": [
      {
        "id": "SF01",
        "type": "boolean",
        "label": "Did anything occur that you would consider a physical or psychological safety event?"
      },
      {
        "id": "SF02",
        "type": "repeat_group_conditional",
        "label": "Safety-event details",
        "fields": [
          "category",
          "severity",
          "onset timing",
          "resolved",
          "resolution timing",
          "medical attention level",
          "emergency services",
          "injury",
          "loss of consciousness",
          "seizure",
          "persistent confusion",
          "persistent perceptual changes",
          "suicidal thoughts",
          "aggressive behavior",
          "description"
        ]
      },
      {
        "id": "SF03",
        "type": "boolean_optional",
        "label": "Did you seek medical or mental-health care because of the experience?"
      },
      {
        "id": "SF04",
        "type": "choice_optional",
        "label": "Highest level of care sought",
        "options": [
          "Peer support only",
          "Outpatient professional",
          "Urgent care",
          "Emergency department",
          "Hospitalization",
          "Other",
          "Unknown"
        ]
      }
    ],
    "followup_core": [
      {
        "id": "FU01",
        "type": "scale_0_10",
        "label": "Overall wellbeing now"
      },
      {
        "id": "FU02",
        "type": "scale_0_10",
        "label": "Mood now"
      },
      {
        "id": "FU03",
        "type": "scale_0_10",
        "label": "Anxiety now"
      },
      {
        "id": "FU04",
        "type": "scale_0_10",
        "label": "Sleep quality"
      },
      {
        "id": "FU05",
        "type": "scale_0_10",
        "label": "Ability to manage usual responsibilities"
      },
      {
        "id": "FU06",
        "type": "scale_0_10",
        "label": "Social connectedness"
      },
      {
        "id": "FU07",
        "type": "scale_0_10",
        "label": "Sense of meaning/purpose"
      },
      {
        "id": "FU08",
        "type": "scale_0_10",
        "label": "Overall perceived benefit attributable to the experience"
      },
      {
        "id": "FU09",
        "type": "scale_0_10",
        "label": "Overall perceived harm attributable to the experience"
      },
      {
        "id": "FU10",
        "type": "scale_0_10",
        "label": "Difficulty making sense of or integrating the experience"
      },
      {
        "id": "FU11",
        "type": "boolean_optional",
        "label": "Are you experiencing persistent distress you associate with the experience?"
      },
      {
        "id": "FU12",
        "type": "boolean_optional",
        "label": "Are you experiencing persistent perceptual changes you associate with the experience?"
      },
      {
        "id": "FU13",
        "type": "boolean_optional",
        "label": "Have new or worsened mental-health symptoms occurred since the experience?"
      },
      {
        "id": "FU14",
        "type": "boolean_optional",
        "label": "Have you sought professional support related to the experience?"
      },
      {
        "id": "FU15",
        "type": "choice_optional",
        "label": "Type of support",
        "options": [
          "Primary care",
          "Mental-health professional",
          "Substance-use professional",
          "Emergency/urgent care",
          "Peer-support service",
          "Spiritual/ceremonial support",
          "Other"
        ]
      },
      {
        "id": "FU16",
        "type": "boolean_optional",
        "label": "Have you made a major life change that you associate with the experience?"
      },
      {
        "id": "FU17",
        "type": "text_long",
        "label": "What changes, if any, have you noticed?"
      },
      {
        "id": "FU18",
        "type": "text_long",
        "label": "Anything else you want to record at this follow-up?"
      }
    ]
  },
  "validated_measure_placeholders": [
    {
      "slot": "baseline_general_health",
      "suggested_family": "PROMIS short forms / CAT, selected for protocol",
      "note": "Do not embed item text in public source code without confirming applicable HealthMeasures terms for the specific use."
    },
    {
      "slot": "acute_phenomenology",
      "suggested_family": "MEQ/CEQ/EDI or other psychedelic-experience scales selected by investigators",
      "note": "Confirm copyright, licensing, scoring, validation population, and permission before implementation."
    },
    {
      "slot": "longitudinal_outcomes",
      "suggested_family": "Validated depression/anxiety/wellbeing/functioning measures selected to match the protocol",
      "note": "Use only measures appropriate to the target research question and permissions."
    }
  ]
}