# WIA-MENTAL-HEALTH: Phase 3 - Protocol Specification **Version:** 1.0 **Status:** Official **Philosophy:** 弘益人間 (Benefit All Humanity) ## 1. Overview This document specifies the communication protocols, assessment procedures, and treatment guidelines for implementing the WIA-MENTAL-HEALTH standard. The core protocol principle is **evidence-based, neuroplasticity-centered care**. ## 2. Assessment Protocols ### 2.1 Standardized Assessment Battery #### 2.1.1 Core Screening Protocol ``` ┌─────────────────────────────────────────────────────────────┐ │ WIA-MENTAL-HEALTH Core Assessment Protocol │ ├─────────────────────────────────────────────────────────────┤ │ STEP 1: Initial Screening (5-10 minutes) │ │ ├── PHQ-2 (Depression Quick Screen) │ │ ├── GAD-2 (Anxiety Quick Screen) │ │ └── PC-PTSD-5 (Trauma Quick Screen) │ │ │ │ STEP 2: Full Assessment (if screens positive) (15-20 min) │ │ ├── PHQ-9 (Depression Full) │ │ ├── GAD-7 (Anxiety Full) │ │ ├── PCL-5 (PTSD Full - if trauma screen positive) │ │ └── WHO-5 (Wellbeing) │ │ │ │ STEP 3: Risk Assessment (2-5 minutes) │ │ ├── Columbia Suicide Severity Rating Scale (C-SSRS) │ │ └── Safety Planning (if indicated) │ │ │ │ STEP 4: Functional Assessment (5-10 minutes) │ │ ├── WHODAS 2.0 (Disability) │ │ └── Quality of Life measure │ └─────────────────────────────────────────────────────────────┘ ``` #### 2.1.2 Assessment Frequency Protocol | Clinical Status | Assessment Frequency | Instruments | |-----------------|---------------------|-------------| | Acute Crisis | Daily | PHQ-2, C-SSRS | | Active Treatment | Weekly | PHQ-9, GAD-7 | | Stable | Monthly | PHQ-9, GAD-7, WHO-5 | | Maintenance | Quarterly | Full battery | | Remission | Semi-annually | Full battery | ### 2.2 Digital Phenotyping Protocol #### 2.2.1 Passive Data Collection ```json { "collection_protocol": { "mobility": { "gps_sampling": "every_15_minutes", "accuracy": "100m_minimum", "battery_optimization": true }, "communication": { "call_logs": "metadata_only", "message_logs": "frequency_only", "content": "never_collected" }, "device_usage": { "screen_time": "aggregated_hourly", "app_categories": true, "specific_apps": false }, "physiological": { "heart_rate": "continuous_when_worn", "sleep": "nightly", "activity": "continuous" } }, "privacy_protocol": { "local_processing": true, "anonymization": "on_device", "transmission": "aggregated_daily", "raw_data_storage": "device_only" } } ``` #### 2.2.2 Phenotype Risk Scores ``` Digital Phenotype Risk Algorithm: ┌───────────────────────────────────────────────────────────┐ │ INPUT FEATURES │ WEIGHT │ ├───────────────────────────────────────────────────────────┤ │ Home time increase (7-day delta) │ 0.20 │ │ Sleep regularity decrease │ 0.18 │ │ Social communication decrease │ 0.17 │ │ Physical activity decrease │ 0.15 │ │ Screen time increase (night) │ 0.12 │ │ Location entropy decrease │ 0.10 │ │ Voice features (if available) │ 0.08 │ ├───────────────────────────────────────────────────────────┤ │ OUTPUT: Relapse Risk Score (0.0 - 1.0) │ │ Threshold: > 0.7 triggers clinical alert │ └───────────────────────────────────────────────────────────┘ ``` ## 3. Treatment Protocols ### 3.1 Evidence-Based Treatment Selection #### 3.1.1 Stepped Care Model ``` ┌─────────────────────────────────────────────────────────────┐ │ STEP 4: Specialist/Intensive Treatment │ │ - Inpatient care │ │ - Intensive outpatient programs │ │ - Electroconvulsive therapy (ECT) │ │ - Psychedelic-assisted therapy (clinical trials) │ ├─────────────────────────────────────────────────────────────┤ │ STEP 3: High-Intensity Interventions │ │ - CBT, DBT, EMDR (individual therapy) │ │ - Medication + therapy combination │ │ - TMS/tDCS neuromodulation │ ├─────────────────────────────────────────────────────────────┤ │ STEP 2: Low-Intensity Interventions │ │ - Guided self-help (digital therapeutics) │ │ - Group therapy │ │ - Peer support programs │ ├─────────────────────────────────────────────────────────────┤ │ STEP 1: Universal Prevention │ │ - Psychoeducation │ │ - Lifestyle interventions (exercise, sleep, diet) │ │ - Stress management apps │ └─────────────────────────────────────────────────────────────┘ ``` #### 3.1.2 Treatment Matching Protocol ```json { "treatment_matching_algorithm": { "inputs": { "diagnosis": "ICD-11 code", "severity": "mild|moderate|severe", "comorbidities": ["list"], "previous_treatments": ["list with outcomes"], "patient_preferences": { "therapy_type": "individual|group|digital", "medication_openness": 0.0-1.0 }, "practical_factors": { "insurance": "coverage_type", "availability": "hours_per_week", "transportation": "accessibility_score" } }, "matching_rules": [ { "condition": "depression_moderate + no_prior_treatment", "first_line": ["CBT", "IPT", "behavioral_activation"], "evidence": "NICE_guidelines_2022" }, { "condition": "depression_severe + failed_2_SSRIs", "options": ["augmentation_strategy", "TMS", "ketamine_referral"], "evidence": "APA_STAR*D_follow_up" }, { "condition": "PTSD + trauma_focused_preference", "first_line": ["EMDR", "CPT", "prolonged_exposure"], "evidence": "VA_DoD_guidelines_2023" } ] } } ``` ### 3.2 Psychotherapy Protocol Standards #### 3.2.1 CBT Protocol Structure ``` Standard CBT Protocol (12-16 sessions): ┌─────────────────────────────────────────────────────────────┐ │ PHASE 1: Assessment & Engagement (Sessions 1-2) │ │ - Comprehensive assessment │ │ - Psychoeducation about CBT model │ │ - Goal setting │ │ - Mood monitoring introduction │ ├─────────────────────────────────────────────────────────────┤ │ PHASE 2: Behavioral Activation (Sessions 3-5) │ │ - Activity scheduling │ │ - Pleasure and mastery activities │ │ - Behavioral experiments │ ├─────────────────────────────────────────────────────────────┤ │ PHASE 3: Cognitive Restructuring (Sessions 6-10) │ │ - Identify automatic thoughts │ │ - Cognitive distortions education │ │ - Thought records │ │ - Core beliefs work │ ├─────────────────────────────────────────────────────────────┤ │ PHASE 4: Skill Consolidation (Sessions 11-14) │ │ - Advanced cognitive techniques │ │ - Problem-solving training │ │ - Stress management │ ├─────────────────────────────────────────────────────────────┤ │ PHASE 5: Relapse Prevention (Sessions 15-16) │ │ - Review progress │ │ - Identify warning signs │ │ - Develop maintenance plan │ │ - Booster session scheduling │ └─────────────────────────────────────────────────────────────┘ ``` #### 3.2.2 Session Documentation Protocol ```json { "session_documentation": { "required_fields": { "session_number": "integer", "date_time": "ISO 8601", "duration_minutes": "integer", "format": "in_person|telehealth", "presenting_concerns": "string", "interventions_used": ["list"], "homework_review": "completed|partial|not_done", "new_homework": "string", "risk_assessment": "none|passive_SI|active_SI|plan", "next_session_plan": "string" }, "optional_fields": { "validated_measure_scores": "object", "session_rating_scale": 0.0-1.0, "alliance_measure": 0.0-1.0 }, "encryption": "required_for_notes" } } ``` ### 3.3 Psychedelic-Assisted Therapy Protocol #### 3.3.1 Safety Screening Protocol ``` PSYCHEDELIC THERAPY SCREENING CHECKLIST ┌─────────────────────────────────────────────────────────────┐ │ ABSOLUTE EXCLUSION CRITERIA │ ├─────────────────────────────────────────────────────────────┤ │ □ Personal history of psychotic disorder │ │ □ First-degree relative with schizophrenia │ │ □ Current manic episode │ │ □ Severe cardiovascular disease (for MDMA) │ │ □ Pregnancy or breastfeeding │ │ □ Current use of MAOIs (for psilocybin) │ │ □ Uncontrolled hypertension │ ├─────────────────────────────────────────────────────────────┤ │ RELATIVE CONTRAINDICATIONS (case-by-case) │ ├─────────────────────────────────────────────────────────────┤ │ □ Bipolar II disorder │ │ □ Severe personality disorders │ │ □ Active substance use disorder │ │ □ History of prolonged psychedelic adverse reactions │ │ □ Current dissociative symptoms │ │ □ Unstable medical conditions │ ├─────────────────────────────────────────────────────────────┤ │ REQUIRED ASSESSMENTS │ ├─────────────────────────────────────────────────────────────┤ │ □ Comprehensive psychiatric evaluation │ │ □ Medical history and physical exam │ │ □ ECG (for MDMA) │ │ □ Urine drug screen │ │ □ Blood pressure monitoring │ │ □ Informed consent process completed │ └─────────────────────────────────────────────────────────────┘ ``` #### 3.3.2 Psilocybin Session Protocol ```json { "psilocybin_session_protocol": { "preparation_phase": { "sessions": 2-3, "duration_each": "60-90 minutes", "objectives": [ "Build therapeutic alliance", "Psychoeducation about psilocybin", "Set intentions", "Discuss expectations and concerns", "Practice grounding techniques" ] }, "dosing_day": { "setting": { "room": "comfortable, home-like environment", "lighting": "soft, adjustable", "temperature": "comfortable (20-22°C)", "music": "curated playlist (Johns Hopkins, Imperial College)", "eye_shades": "available", "comfortable_furniture": "bed or reclining chair" }, "timeline": { "T-60min": "Arrival, vital signs, final preparation", "T-0": "Dose administration (oral capsule)", "T+30-45min": "Onset of effects", "T+60-120min": "Peak experience", "T+4-6h": "Resolution phase", "T+6-8h": "Integration conversation, discharge planning" }, "monitoring": { "vital_signs": "every 30 minutes during peak", "psychological_support": "continuous presence of trained facilitators", "documentation": "experience notes (with consent)" }, "support_interventions": [ "Grounding techniques", "Breathing exercises", "Reassurance ('Trust, let go, be open')", "Physical comfort (blankets, water)", "Music adjustments" ] }, "integration_phase": { "sessions": 3-6, "timing": "Day 1, Week 1, Week 2, Week 4, Month 2, Month 3", "techniques": [ "Narrative processing of experience", "Connecting insights to life", "Somatic integration", "Creative expression (art, journaling)", "Mindfulness practice continuation" ] } } } ``` ### 3.4 Digital Therapeutics Protocol #### 3.4.1 Prescription Digital Therapeutic Workflow ``` PDT IMPLEMENTATION WORKFLOW ┌─────────────────────────────────────────────────────────────┐ │ 1. ASSESSMENT │ │ ├── Confirm diagnosis (ICD-11 code) │ │ ├── Verify PDT indication match │ │ └── Check contraindications │ ├─────────────────────────────────────────────────────────────┤ │ 2. PRESCRIPTION │ │ ├── Select appropriate PDT │ │ ├── Generate prescription code │ │ └── Set treatment duration (typically 90 days) │ ├─────────────────────────────────────────────────────────────┤ │ 3. ONBOARDING │ │ ├── Patient downloads app │ │ ├── Enters prescription code │ │ ├── Completes baseline assessment │ │ └── Configures notification preferences │ ├─────────────────────────────────────────────────────────────┤ │ 4. ACTIVE TREATMENT │ │ ├── Patient completes modules │ │ ├── Real-time engagement tracking │ │ ├── Provider dashboard monitoring │ │ └── Automated alerts for non-adherence │ ├─────────────────────────────────────────────────────────────┤ │ 5. OUTCOME ASSESSMENT │ │ ├── Weekly symptom measures │ │ ├── Module completion tracking │ │ ├── Engagement analytics │ │ └── Treatment response categorization │ ├─────────────────────────────────────────────────────────────┤ │ 6. CLINICAL REVIEW │ │ ├── Monthly provider check-ins │ │ ├── Treatment adjustment if needed │ │ └── Transition planning (maintenance or step-up) │ └─────────────────────────────────────────────────────────────┘ ``` ## 4. Crisis Protocol ### 4.1 Crisis Detection and Response ``` CRISIS RESPONSE PROTOCOL ┌─────────────────────────────────────────────────────────────┐ │ LEVEL 1: LOW RISK │ │ - Passive suicidal ideation without intent │ │ - No plan, no access to means │ │ → Action: Safety plan review, increase monitoring │ ├─────────────────────────────────────────────────────────────┤ │ LEVEL 2: MODERATE RISK │ │ - Suicidal ideation with some intent │ │ - Vague plan, limited access to means │ │ → Action: Same-day clinical contact, restrict means │ ├─────────────────────────────────────────────────────────────┤ │ LEVEL 3: HIGH RISK │ │ - Active suicidal ideation with intent │ │ - Specific plan, access to means │ │ → Action: Immediate clinical intervention, possible ED │ ├─────────────────────────────────────────────────────────────┤ │ LEVEL 4: IMMINENT RISK │ │ - Imminent danger to self │ │ - Active psychosis with command hallucinations │ │ → Action: Emergency services (911/988), stay on line │ └─────────────────────────────────────────────────────────────┘ ``` ### 4.2 Safety Planning Protocol ```json { "safety_plan": { "step_1_warning_signs": [ "Patient-identified early warning signs", "Thoughts, images, moods, situations, behaviors" ], "step_2_coping_strategies": [ "Internal coping strategies patient can do alone", "Distraction, relaxation, physical activity" ], "step_3_social_supports": [ { "name": "Contact name", "relationship": "Friend/Family", "phone": "Contact number" } ], "step_4_professional_contacts": [ { "provider": "Therapist name", "phone": "Office number", "crisis_line": "After-hours number" }, { "resource": "988 Suicide & Crisis Lifeline", "phone": "988", "availability": "24/7" } ], "step_5_means_restriction": { "lethal_means_identified": ["list"], "restriction_plan": "Detailed plan to limit access" }, "step_6_reasons_for_living": [ "Patient-identified reasons to stay alive" ], "digital_access": true, "emergency_contact_notified": true, "last_reviewed": "ISO 8601 date" } } ``` ## 5. Interoperability Protocol ### 5.1 EHR Integration ```json { "ehr_integration": { "standards_supported": ["HL7 FHIR R4", "CDA R2"], "resources": { "Patient": "demographics", "Condition": "diagnoses (ICD-11)", "Observation": "assessment scores", "CarePlan": "treatment protocols", "MedicationRequest": "prescriptions", "Appointment": "session scheduling", "QuestionnaireResponse": "assessment responses" }, "data_exchange": { "real_time": ["vital_signs", "crisis_alerts"], "batch": ["session_notes", "assessments"], "on_demand": ["treatment_summaries"] } } } ``` ### 5.2 Wearable Device Protocol ```json { "wearable_integration": { "supported_data": { "heart_rate": { "sampling": "continuous or 5-minute intervals", "format": "bpm with timestamp" }, "hrv": { "metrics": ["rmssd", "sdnn", "lf_hf"], "calculation": "5-minute windows" }, "sleep": { "stages": ["awake", "light", "deep", "rem"], "granularity": "30-second epochs" }, "activity": { "steps": "hourly aggregates", "exercise": "detected sessions" } }, "protocols": ["Apple HealthKit", "Google Fit", "Fitbit Web API", "Garmin Connect"], "sync_frequency": "daily minimum, real-time preferred" } } ``` ## 6. Data Security Protocol ### 6.1 Encryption Standards | Data State | Encryption | Algorithm | |------------|------------|-----------| | At Rest | Required | AES-256-GCM | | In Transit | Required | TLS 1.3 | | In Processing | Required | Secure enclave where available | | In Backup | Required | AES-256 + separate key | ### 6.2 Access Control Protocol ```json { "access_control": { "authentication": { "method": "OAuth 2.0 + OpenID Connect", "mfa": "required for clinical access", "session_timeout": "30 minutes inactive" }, "authorization": { "model": "Role-Based Access Control (RBAC)", "roles": [ { "role": "patient", "access": ["own_data", "assessment_submission", "treatment_progress"] }, { "role": "therapist", "access": ["assigned_patients", "session_notes", "treatment_planning"] }, { "role": "psychiatrist", "access": ["assigned_patients", "prescribing", "neuroimaging"] }, { "role": "researcher", "access": ["anonymized_aggregate_data"] } ] }, "audit_logging": { "all_access": true, "retention": "7 years minimum", "tamper_proof": true } } } ``` ## 7. Quality Assurance Protocol ### 7.1 Treatment Fidelity Monitoring ``` FIDELITY MONITORING CHECKLIST ┌─────────────────────────────────────────────────────────────┐ │ □ Protocol adherence rating (0-100%) │ │ □ Competency assessment completed │ │ □ Supervision documentation current │ │ □ Patient outcome tracking active │ │ □ Adverse event reporting up to date │ │ □ Continuing education requirements met │ └─────────────────────────────────────────────────────────────┘ ``` ### 7.2 Outcome Measurement Protocol | Measure | Frequency | Target | |---------|-----------|--------| | Symptom reduction | Weekly | ≥50% reduction at endpoint | | Response rate | End of treatment | ≥50% of patients | | Remission rate | End of treatment | ≥30% of patients | | Dropout rate | Ongoing | ≤20% | | Patient satisfaction | End of treatment | ≥4.0/5.0 | --- **弘益人間 (Benefit All Humanity)** *© 2025 WIA - World Certification Industry Association* *MIT License*