Highlight
1. Patients with inflammatory rheumatic diseases (IRDs) often suffer psychological distress but have limited access to psychological care.
2. A randomized clinical trial in Germany investigated a self-guided digital psychological intervention versus treatment as usual in individuals with rheumatoid arthritis, psoriatic arthritis, or systemic lupus erythematosus.
3. The intervention group showed significant reductions in psychological distress and improvements in quality of life at 3 months, with moderate to large effect sizes.
4. No adverse events were reported, highlighting safety and potential scalability of such digital interventions in rheumatology.
Study Background and Disease Burden
Inflammatory rheumatic diseases—including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and systemic lupus erythematosus (SLE)—are chronic autoimmune conditions characterized by systemic inflammation that leads to joint damage, pain, and disability. Beyond the physical burden, patients frequently endure substantial psychological distress, including anxiety and depression, which compromises their quality of life and disease outcomes. Psychological distress is often underrecognized and undertreated in rheumatology due to limited access to mental health professionals, stigma, and the complexity of chronic disease management.
The increasing availability of digital health technologies offers opportunities to deliver scalable psychological support remotely. However, evidence for their effectiveness in IRDs is limited. This pilot trial was designed to assess whether a self-guided digital psychological intervention can reduce psychological distress and improve quality of life in patients with IRDs, addressing a critical unmet need.
Study Design
This randomized clinical trial recruited 102 adults aged 18 years or older across Germany between February 22 and June 4, 2024. Eligibility criteria included diagnosed RA, PsA, or SLE along with self-reported psychological distress and reduced quality of life. Participants were randomized into two groups:
- Intervention group (n=52): received access to a self-guided digital psychological intervention designed to address distress and enhance coping skills.
- Control group (n=50): continued treatment as usual without additional psychological support.
The intervention incorporated evidence-based psychological techniques targeting anxiety, depression, and stress management, delivered via an accessible digital platform routinely available to patients.
Primary outcomes measured changes from baseline to 3 months in psychological distress using the German version of the Hospital Anxiety and Depression Scale (HADS) and quality of life using the Assessment of Quality of Life-8 Dimensions (AQoL-8D). Secondary outcomes assessed self-efficacy, health literacy, perceived stress, functional impairment, depression, and anxiety to comprehensively evaluate psychological and functional domains.
Key Findings
The mean age of participants was 47.2 years, and 90.2% were female, reflecting the higher prevalence of IRDs among women.
Primary outcomes:
- The intervention group showed a statistically significant mean reduction in psychological distress at 3 months compared to controls (least-squares mean difference: -3.60; 95% CI, -5.73 to -1.47; P < .001), with a Cohen’s d effect size of -0.71, indicating a moderate to large effect.
- Quality of life improved significantly in the intervention group relative to controls (least-squares mean difference: 0.04; 95% CI, 0.00-0.09; P = .047), with a Cohen’s d effect size of 0.49, signifying a moderate effect.
- A higher proportion of participants in the intervention group achieved clinically meaningful improvements: 59.2% versus 34.0% for psychological distress (P = .02) and 55.1% versus 32.0% for quality of life (P = .03).
Secondary outcomes:
- Significant improvements were noted in self-efficacy, health literacy, perceived stress, depression, and anxiety in the intervention group relative to controls.
- Functional impairment did not show a statistically significant difference between groups at 3 months, suggesting physical function may require longer-term or complementary interventions.
Safety: No adverse events related to the digital intervention were reported, supporting its safety and acceptability.
Expert Commentary
This study provides promising evidence supporting the use of self-guided digital psychological interventions in individuals with IRDs, who traditionally face barriers to accessing mental health care. The moderate to large effect sizes observed for distress reduction and quality of life improvement are clinically meaningful given the chronic and debilitating nature of IRDs.
While the positive impact on psychological parameters is encouraging, the lack of significant change in functional impairment highlights the multifactorial challenges in IRD management. Physical symptoms may require integrated approaches combining medical, physical, and psychological therapies.
Limitations of this pilot study include a predominantly female sample which limits generalizability to males and potentially other IRD populations not studied such as ankylosing spondylitis. The 3-month follow-up is relatively short; longer studies are needed to assess sustained benefits. Furthermore, the self-guided nature of the intervention raises questions about adherence rates and engagement, which warrant further investigation.
Nevertheless, these findings are consistent with broader literature demonstrating the efficacy of digital mental health interventions in chronic disease populations. They underscore the potential for scalable, low-cost psychological support to improve comprehensive care in rheumatology.
Conclusion
This pilot randomized clinical trial supports the effectiveness and safety of a self-guided digital psychological intervention in reducing psychological distress and enhancing quality of life among individuals with inflammatory rheumatic diseases. The findings address a critical gap in rheumatology by providing evidence for an accessible, scalable mental health intervention that can complement traditional treatment paradigms.
Future research should aim to verify these results in larger, diverse populations, explore intervention optimization to enhance adherence, and investigate strategies to integrate digital psychological support into routine rheumatology care pathways. Ultimately, expanding access to digital mental health resources may improve holistic outcomes and patient well-being in IRDs.
References
1. Knitza J, Kraus J, Krusche M, Haase I, Klemm P, Hueber AJ, Pfeil A, Drott U, Kuhn S, Klein JP. Digital Psychological Intervention for Inflammatory Rheumatic Diseases: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529892. doi: 10.1001/jamanetworkopen.2025.29892. PMID: 40924426.
2. Matcham F, Scott IC, Rayner L, et al. The impact of rheumatoid arthritis on quality-of-life assessed by the SF-36: a systematic review and meta-analysis. Semin Arthritis Rheum. 2014;44(2):123-130.
3. Biswas M, Torti J, Bird HA. Psychological interventions in rheumatoid arthritis. Rheumatology (Oxford). 2019;58(8):1251-1261.
4. Andersson G. Internet-Delivered Psychological Treatments. Annu Rev Clin Psychol. 2016;12:157-179.
