A digital, self-guided therapy program significantly improved psychological distress and quality of life in patients with inflammatory rheumatic disease (IRD) compared with a standard-treatment program, according to a pilot randomized trial.

Researchers, led by Johannes Knitza, MD, PhD, with the Institute for Digital Medicine at Philipps-Universität Marburg in Marburg, Germany, concluded that the “findings highlight the potential of digital mental health interventions in addressing the unmet psychological needs” of people with IRDs. They published their findings on September 9, 2025, in JAMA Network Open.

IRDs, including chronic diseases such as rheumatoid arthritis (RA), systemic lupus erythematosus, and psoriatic arthritis, are increasingly prevalent, with a lifetime risk of 8.4% for women and 5.1% for men in the US, the authors noted.

Digital Option May Help Long Wait Times

In addition to physical symptoms, patients with IRDs often face considerable psychological challenges. About 15%-24% of patients experience depression and 19%-37% have anxiety, rates that are significantly higher than those in the general population. Distress feeds disease flares, which in turn feed more psychological distress. The cycle erodes quality of life but also results in substantial costs. The authors cited as an example the average yearly cost of $3382 for a patient with RA in the US.

Psychological support for patients with IRD has been proven effective and is recommended in guidelines, but access to the support is limited by a shortage of service providers, leading to long wait times.

In the RELIEVE trial, 102 adult patients (average age, 47.2 years; 90% women) were randomly assigned to either the intervention group (n = 52) or the control group (n = 50). The trial aimed to evaluate the effectiveness of the intervention called Vila RaVie,

Clinically Relevant Improvements in Outcomes

The primary outcomes were change in psychological distress (measured by the German version of the Hospital Anxiety and Depression Scale [HADS-D]) and quality of life (measured by the Assessment of Quality of Life-8 Dimensions [AQoL-8D]) from baseline to 3 months.

In the intervention group, the average total HADS-D score decreased from 19.60 at baseline to 13.35 at posttreatment compared with a reduction from 20.42 at baseline to 17.36 after treatment in the control group. A significantly greater percentage of participants in the intervention group reached the minimal clinically important difference (MCID) for HADS-D compared with the control group (29 [59.2%] vs 17 [34.0%]; odds ratio [OR], 2.81; 95% CI, 1.24-6.37; P = .02).

Additionally, the proportion of participants achieving the MCID with the AQoL-8D score was significantly higher in the intervention group (27 [55.1%] vs 16 [32.0%]; OR, 2.61; 95% CI,1.15-5.91; P = .03).

In secondary results, depression, as measured by the Patient Health Questionnaire, also improved significantly, and anxiety, assessed via the Generalized Anxiety Disorder 7, showed a significant reduction, the researchers reported.

Adherence, Retention Strong

“I went in cautiously optimistic,” lead author Knitza told Medscape Medical News. “But the size and consistency of the effect still surprised me. Equally striking was patient behavior: Adherence and retention were far better than we typically see, with very few dropouts and steady engagement over time.” Importantly, he said, “the intervention is not only effective under study conditions; it is also acceptable and feasible in everyday care.”

He explained that the therapy program uses a simulated dialogue to guide users through 80 steps, which can be completed within 12 weeks. Each step takes about 5-15 minutes, so patients typically do roughly a step a day.

This study addresses two key conditions, depression and anxiety, which go largely undetected and undertreated with rheumatic disease, Knitza said.

“Many rheumatologists do not screen consistently because they feel they cannot offer timely, accessible treatment. That barrier has changed. Evidence-based digital interventions provide immediate, scalable support,” he said. “With these options, routine screening with brief validated tools should become standard practice, and opting not to screen is no longer acceptable.”

Breaking the IRD Stress Cycle

Ryan Sultan, MD, assistant professor of clinical psychiatry at Columbia University in New York City and founder and medical director of Integrative Psychiatry in New York City and Miami explained the cycle of stress for patients with IRD.

“Chronic inflammation from conditions like inflammatory rheumatic disease affects brain chemistry, sleep, and energy, which influence the development of mood disorders. They are also unpredictable. The stress of not knowing when you might have a flare-up or feel significantly worse will undoubtedly amplify feelings of stress and anxiety,” he said.

The digital, self-guided program this study describes appears to work well, he told Medscape Medical News, “because it is grounded in evidence-based principles of cognitive behavioral therapy (CBT), which is used in therapeutic settings to treat depression and anxiety. It was also codesigned by patients, allowing for a blend of evidence-based approaches and lived experiences.”

Promising in the US?

Sultan said the program appears very promising for potential use in the US. “US patients with similar inflammatory conditions also have elevated rates of depression (15%-25%) and anxiety (20%-40%), very similar to the German sample,” he said. “The US is also trending toward digital therapeutics, so the program intervention makes sense in the context of recent trends.”

Rheumatologist David Pisetsky, MD, PhD, professor of medicine at Duke University in Durham, North Carolina, said he also sees the intervention as promising in the US.

He pointed out that the researchers found no meaningful effects for pain or the Patient Global Assessment, both of which are key outcomes. He said he’d like to know why it didn’t affect pain “because there are CBT approaches that affect pain.” Also, “you’d like to have an intervention that leads to a higher Global Assessment,” he said.

Optimally, comparative studies are needed, he said, such as how digital interventions stack up with other therapies. And it would need to be tested in a US population and considered within the costs of the US healthcare system, “which in itself can become a source of anxiety,” he noted.

“Getting psychiatric or psychological care is difficult as the article indicates,” Pisetsky said. “If digital interventions work, that would be very helpful for the right patient,” he told Medscape Medical News. “We’re in a system where we’re exploring adjunctive methods of care that don’t necessarily involve providers. We just need more clinical trials to see how they fit in.”

“It’s definitely worth exploring, especially if it is cost effective and more widely available,” he said.

This study was supported by Vila Health GmbH in Berlin, Germany. Knitza reported receiving personal fees from Vila Health during the conduct of the study and personal fees from GAIA outside the submitted work.

Sultan and Pisetsky reported no relevant financial relationships.

Marcia Frellick is an independent Chicago-based healthcare journalist and a regular contributor to Medscape.