By Pat Anson

It was a little over a year ago that the FDA authorized the marketing of the first smartphone app designed specifically to treat fibromyalgia. The Stanza app uses a form of cognitive behavioral therapy (CBT) to help patients improve their quality of life by lessening the pain, anxiety, fatigue and depression that often come with fibromyalgia.

New findings from a placebo-controlled Phase 3 study, recently published in the The Lancet, helped demonstrate Stanza’s potential benefits.  

“This novel, non-drug therapy, available using a smartphone, makes management of fibromyalgia more accessible and convenient. This offers new hope for people with fibromyalgia, who have continued to experience unmet treatment needs,” says lead investigator Lesley Arnold, MD, an Associate Professor of Psychiatry at the University of Cincinnati College of Medicine.

Arnold and her colleagues enrolled 275 fibromyalgia patients in a 12-week trial, with half randomly assigned to receive Stanza treatment and the other half serving as a control group. Participants were allowed to continue taking medications and any other therapies they were using before the study.

Fibromyalgia is a difficult condition to diagnose and treat, because it comes with a wide array of symptoms such as widespread body pain, headaches, fatigue, insomnia, brain fog and mood disorders. The FDA has approved only three medications for fibromyalgia -- duloxetine (Cymbalta), milnacipran (Savella), and pregabalin (Lyrica) – but many patients consider the drugs ineffective or have too many side effects.

Stanza uses a form of CBT called Acceptance and Commitment Therapy (ACT) to teach patients psychological skills to help lessen the impact of fibromyalgia on their lives. A daily 15–20-minute session includes ACT lessons on deep breathing, mindfulness and other self-management skills.   

The effectiveness of Stanza was measured by the patients themselves, through a self-assessment test known as Patient Global Impression in Change (PGIC), in which participants described changes in their overall well-being.  

After 12 weeks, over 70% of participants in the Stanza group had improvements in their PGIC score, compared to 22% in the control group. Stanza participants also had more significant improvement in their pain intensity, physical function, fatigue, sleep and depression. No adverse events were observed either group.

It’s important to note the research was funded by Swing Therapeutics, the maker of Stanza, which calls it largest study ever conducted of a medical device for fibromyalgia.

“Fibromyalgia options are typically limited to a handful of pharmacological interventions that have limited efficacy and that can come with difficult-to-manage side effects,” says Mike Rosenbluth, CEO of Swing. “This publication validates Stanza as a guideline-directed non-drug approach that many patients previously couldn’t access due to few available trained clinicians, geographic limitations and cost.

Stanza is intended for use five to seven days per week, for a standard treatment period of 12 weeks. After that, Stanza can be used as needed. Previous studies have found that improvements in fibromyalgia symptoms can last up to 12 months after Stanza therapy.

Although it’s a self-guided app, Stanza requires a prescription and the supervision of a medical professional trained in its use.  Currently, Stanza clinicians are only available in the states of Illinois, Michigan, Missouri, Nevada, Ohio, Pennsylvania, Tennessee and Texas.  Medicare Part B and some private insurers cover Stanza treatment.