Stanza MVP: FDA-Cleared CBT App for Fibromyalgia

The impact

73% of pilot participants reported improved well-being. FDA pivotal trial launched on time. Stanza became the first FDA-cleared CBT app for fibromyalgia.

I partnered with Swing Therapeutics to build the MVP for Stanza, a mobile cognitive behavioral therapy app for chronic pain. The work translated clinical insight into a scalable, compassionate, trial-ready product on iOS and Android, HIPAA-compliant, FDA-ready, and built around the real constraints of people managing fibromyalgia.

The patient's worst day was the design constraint

Fibromyalgia makes everything harder, including using software. Patients live with chronic fatigue, cognitive fog, and unpredictable pain episodes. The generalist version of this product designs for the average user on an average day. That product fails the people who need it most, because a 45-minute session is not a session a fibromyalgia patient can complete during a flare. So the binding constraint was the bad day, not the typical one. Every clinical and UX decision had to hold up when the user has the least capacity, while still satisfying protocols the FDA would audit.

I worked directly with clinicians to define a 15-minute daily model built on Acceptance and Commitment Therapy, then set the lesson architecture (chapters, daily goals, reflections) that gave the program its clinical coherence.

Decouple the clinicians from the engineers

The highest-leverage decision was structural. In a regulated digital therapeutic, the clinical team needs to iterate on content and the engineering team needs to ship a stable, auditable app, and if those two are coupled, every wording change becomes an engineering ticket and the trial timeline dies. So I built a YAML-based CMS that let clinicians deliver content across text, audio, and image without engineering in the loop, with pacing logic, behavioral nudges, and gating rules aligned to the FDA-audited trial protocols. That separation is why the pivotal trial launched on time.

It only works with discipline underneath it. Terminology, information architecture, and publishing had to stay consistent across clinicians, engineers, and product, or the system would fracture the first time anyone updated content or ran QA. I set shared language early and built the review and publication protocols to keep it coherent.

What this built

• The first FDA-cleared CBT app for fibromyalgia. A clinical-grade iOS and Android product that passed FDA audit and launched into a pivotal trial.
• A reusable digital therapeutic platform. The lesson architecture, CMS, and content delivery patterns Swing built for Stanza could extend to other chronic conditions and therapeutic programs.
• A product experience designed for the patient, not the protocol. Flexibility for flare-up days, structure for the trial - and 73% of pilot participants reported feeling better for it.