Regulatory scope
Class I software as a medical device in Great Britain, UKCA-marked; UK GDPR
A UKCA-Marked Digital Therapeutic Delivering a Full CBT Course for Anxiety
Not a wellness app. A regulated software as a medical device, UKCA-marked for use in Great Britain, delivering a structured cognitive behavioral therapy program authored by an in-house cognitive psychologist with twenty years in CBT and reviewed by multiple clinicians. Seasia engineered the platform: clinical screening, session progression, therapy logging, an AI support companion and crisis escalation - built to WCAG 2.1 AA.
Overview
INDUSTRY
Digital Therapeutics/ Mental Health/ SaMD
PROJECT DURATION
3 years, ongoing
Access to cognitive behavioral therapy is limited by clinician availability rather than by evidence. Delivering a complete CBT course through software meant building a regulated medical device rather than a wellness app: a Class I product, UKCA-marked for Great Britain, carrying the change control, traceability and documented risk position that classification demands.
Seasia engineered the platform end to end: a clinically sequenced therapeutic program, screening users can retake to see their own symptom change, persistent crisis support, and an admin layer that lets the client's psychologists update clinical content without an app release.
Overview
Access to cognitive behavioral therapy is limited by clinician availability rather than by evidence. Delivering a complete CBT course through software meant building a regulated medical device rather than a wellness app: a Class I product, UKCA-marked for Great Britain, carrying the change control, traceability and documented risk position that classification demands.
Seasia engineered the platform end to end: a clinically sequenced therapeutic program, screening users can retake to see their own symptom change, persistent crisis support, and an admin layer that lets the client's psychologists update clinical content without an app release.
INDUSTRY
Digital Therapeutics/ Mental Health/ SaMD
PROJECT DURATION
3 years, ongoing
Project Scope & Business Challenges
The platform needed to deliver structured CBT within the constraints of regulated medical software. That meant balancing clinical sequencing, safety escalation, and traceability with a user experience that remained clear and accessible.
Key challenges included:
Regulated Software, Not A Wellness Product.
- A Class I medical device carries obligations a wellness app does not – controlled change management, traceability from requirement through verification, and a documented risk position. Engineering practice had to match the regulatory class from the first commit.
Therapeutic Sequence Is Clinical, Not A UX Preference.
- CBT works because concepts are built in order. The platform had to enforce sequential progression; each session gated on completion of the last, without the gating feeling punitive to a user already managing anxiety.
A User In Distress Must Never Hit A Dead End.
- When screening indicates severe range, the path to professional support has to be immediate and must survive app closure, interruption and relaunch. This is a safety requirement, engineered as one.
Solution Offered by Seasia
Seasia engineered a clinically structured CBT platform with controlled progression, guided exercises, outcome tracking, and persistent crisis support pathways. The solution translated therapeutic and regulatory requirements into predictable, auditable product workflows.
Structured program engine
The CBT course is modelled as sessions, parts and pages, driven by a controlled page array, so progression is sequential, predictable, and clinically faithful. The progress bar updates proportionally as each page completes.
Sequential session unlocking
Sessions gate on completion of prerequisites, with clear visual state for completed, active and locked, so foundational concepts land before more complex material.
Clinical screening and outcome tracking
A screening instrument at onboarding with a scored results screen, which can be retaken through the program, so users see symptom change over time rather than being told about it.
CBT exercise suite
Worry diary, worry tree, worry script, belief testing and uncertainty management, each a guided structured interaction with instructional video support rather than a free-text box.
Crisis escalation pathway
When screening or reported state falls in the severe range, a crisis support pathway surfaces immediate access to professional crisis services. Safety-critical context persists across interruption and relaunch, so the pathway remains available after the app closes.
AI support companion
An AI conversational companion offering empathetic support between structured sessions in a calm, clearly delineated chat interface, positioned as support alongside the therapeutic program rather than a substitute for it.
Mood tracking and therapy log
Visual mood history with daily entry, and a therapy log letting users read back their own reflections from previous sessions, a clinical feature of CBT, not a journaling add-on.
Multi-layer persistence
Session persistence with secure access and refresh token management under strict expiry rules, data persistence for mood logs, milestones, chat history and self-care records synced across devices; onboarding persistence capturing every answer, branch and skip in real time so a user returns exactly where they left off.
Self-care library and signposting
Mindfulness audio, podcasts and articles, plus signposting to support groups and helplines outside the app.
Reminder and goal engine
Configurable weekly reminders by day, daily goal tracking and personal goal management, supporting the adherence a therapeutic program depends on.
Organization-code onboarding
An optional organization code at signup, enabling employer, insurer and health-system distribution against a single consumer build.
Dynamic admin platform
Screens, content, users and system settings managed from an admin panel, so clinical content updates ship without an app release.
Security and resilience testing
Vulnerability assessment and penetration testing, load and performance testing across mobile, web and backend; high-risk vulnerabilities identified and resolved; API and network hardening; database audits and custom session testing.
WCAG 2.1 AA accessibility
Built to WCAG 2.1 AA throughout, as a design standard rather than a remediation pass.
Our Tech Stack
Frontend
React Native
JavaScriptBackend
Node.jsPlatforms
iOS
AndroidAuthentication
AWS CognitoFrontend
React NativeJavaScriptBackend
Node.jsPlatforms
iOSAndroidAuthentication
AWS CognitoCompliance & Security
Safeguards
AWS Cognito authentication, secure session and refresh token management with strict expiry, role-based access control and strict session management, API and network hardening, VAPT-verified
Data handling
Mental health data secured and synced under client-controlled backend; privacy policy and terms consent captured before account activation
Delivery standards
Program authored by an in-house cognitive psychologist with 20 years in CBT; content reviewed by multiple psychologists; crisis escalation engineered as a persistent safety-critical state
Features & Outcomes Delivered
The platform combined structured CBT delivery, patient self-management, safety workflows, content administration, and enterprise-grade controls in a single regulated digital health experience. The result was a clinically guided system designed for continuity, accessibility, and scalable organizational deployment.
Clinical Programs & Therapeutic Workflows
- Structured CBT program with sequential session unlocking
- Clinical screening with scored results and retake tracking
- Worry diary, worry tree, worry script, belief testing and uncertainty management exercises
- Therapy log with cross-session reflection recall
- Goal setting and daily goal management
Patient Support & Engagement
- AI conversational support companion
- Mood tracking with visual history
- Configurable weekly reminders
- Self-care library with mindfulness audio, podcasts, articles and external signposting
Safety & Continuity Of Care
- Crisis escalation pathway with persistent safety–critical state
- Multi-layer persistence across session, data and onboarding state
Administration & Enterprise Distribution
- Organization-code onboarding for employer and health-system distribution
- Dynamic content and user administration platform
Accessibility, Security & Quality Assurance
- WCAG 2.1 AA accessibility throughout
- VAPT, load and performance test program
Results
A Class I medical device, UKCA-marked for Great Britain
A structured CBT program in production on iOS and Android
WCAG 2.1 AA conformance built in from design rather than retrofitted
VAPT, load and performance testing completed with high-risk vulnerabilities resolved
Role-based access control and strict session management implemented across the platform
Clinical content updates shipping through the admin panel without an app release
Ongoing maintenance keeping the platform secure and performance-optimized
A 3-year engagement, still running
Building a regulated digital therapeutic?
Seasia helps healthcare organizations design and engineer secure, clinically structured digital therapeutics with the compliance, safety, and scalability required for real-world deployment.
From the Seasia Engineering Lab
The intelligence layer behind how Seasia teams plan, engineer, test, release, and govern enterprise software.