The app, approved for use in the US, provided symptom improvement for patients in the short-term – but questions remain over its long-term efficacy.
Clinical analysis of a self-guided digital acceptance and commitment therapy (ACT) has shown positive results in helping to manage fibromyalgia symptoms.
Results of the phase 3, multi-centre randomised controlled trial, known as PROSPER-FM, were published this month in The Lancet.
The trial set out to assess the efficacy and safety of a digital, self-guided therapeutic app called Stanza for the management of fibromyalgia.
Stanza received US FDA De Novo marketing authorisation in 2023, as the first digital therapeutic indicated for treating fibromyalgia symptoms. It is available by prescription through Swing Care, a virtual specialty clinic in the US focused on the treatment of chronic pain.
The trial, conducted at 25 US community sites, included adults aged 22–75 years with fibromyalgia, who were randomly assigned (1:1) to the digital ACT group or an active control group that offered daily symptom tracking and monitoring and access to health-related and fibromyalgia-related educational materials.
The primary endpoint was patient global impression of change (PGIC) response rate at week 12. Analyses were by intention to treat.
Between 8 February 2022, and 2 February 2023, 590 individuals were screened, of whom 275 (257 women and 18 men) were randomly assigned to the digital ACT group (n=140) and the active control group (n=135).
At 12 weeks, 99 of 140 (71%) ACT participants reported improvement on PGIC versus 30 of 135 (22%) active control participants, corresponding to a difference in proportions of 48·4% (95% CI 37·9–58·9). No device-related safety events were reported.
“Results of the PROSPER-FM randomised clinical trial showed that digital ACT is an effective and safe treatment for fibromyalgia that progressively improved clinical outcomes throughout the course of the study,” the authors wrote.
“Compared with symptom tracking active control, digital ACT was associated with a greater PGIC response rate and decreased functional impairment as measured by FIQ-R, with significant benefits emerging early in treatment between weeks 2 and 7 on nearly all measures.
“In addition, the superiority of digital ACT in comparison to the active control was shown on most secondary and exploratory endpoints with typically medium effect sizes for measures of fibromyalgia-associated symptoms, including fatigue, sleep problems, pain intensity, pain interference, and mood. In alignment with the objectives of ACT, the benefits provided by digital ACT might have resulted at least in part from an increased capacity to confront difficulties and adapt, as evidenced by significant improvements in measures of psychological flexibility.”
Monash Health rheumatologist Dr Emma Guymer, who has a special interest in fibromyalgia, told Rheumatology Republic the findings were promising and added to what was already known about the use of CBT in helping manage symptoms.
“We know CBT approaches are beneficial in managing symptoms, we know that, and we’ve had a suspicion that that being able to do it remotely could also be helpful too,” she said.
“But the data has been really patchy and it’s been very hard to categorically say yay or nay. This is looking at one specific program that’s developed by the study sponsors, but it’s been developed in concert with some really good people in the field.
“And it seems to have come up with some really good results, real world results. It’s really pleasing to have this sort of quality of data available.”
Dr Guymer said the use of an app had the potential to overcome some of the difficulties patients, particularly those located in rural and remote areas, had accessing this sort of treatment.
“Remote therapies can partly address some of the difficulties that patients can confront when they’re trying to access this appropriate sort of treatment,” she said.
“And the fact that there was a high adherence rate suggests that the patients will engage and can benefit from effective strategies.”
The authors said this study was the first large-scale ACT-based, randomised, and active controlled multicentre study for fibromyalgia treatment.
“The ACT smartphone-delivered self-guided digital therapy was designed to be used remotely without needing a trained therapist, making ACT more accessible to people with fibromyalgia,” they wrote.
“Despite the clinical evidence that ACT approaches are beneficial in fibromyalgia management, access is limited by insufficient trained therapists, distance to treatment centres, barriers to referrals, in-person treatment cost, and inadequate insurance reimbursement.”
The researchers acknowledged that long-term (beyond 12 weeks) clinical benefits of ACT in fibromyalgia had not yet been demonstrated but were under evaluation. They also pointed out that other ACT-based interventions for fibromyalgia have shown long-term clinical benefits at follow-up.
“Given the self-guided nature of the intervention and the strong safety profile, prescribing clinicians managing fibromyalgia patients could also prescribe digital ACT,” they concluded.
“Further research is needed to assess treatment effectiveness in a real-world setting, long-term clinical effectiveness, patient characteristics and engagement that predict positive outcomes, and the overall cost-effectiveness of the treatment.”
Dr Guymer said this was an important consideration.
“We don’t have any information about whether the changes are sustained over time, or whether you have to keep doing it [beyond 12 weeks],” she told RR.
“Do you have to keep on the program for the benefits to continue – that’s an important question. And the other thing too is that smartphones are technology, and they are expensive, and you want to make sure there’s some tech support. If someone’s paying for some something like this, people could have problems accessing or using the technology.”
Rheumatology Republic contacted Swing Care to find out whether the company planned to expand into Australia, however had not received a response by deadline.
However Swing Care’s CEO Mike Rosenbluth released a statement following the publication of The Lancet article, saying it “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”.
“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,” he said.
