Digital Psychological Intervention for Inflammatory Rheumatic Diseases: A Pilot Randomized Clinical Trial
Primary result · Change in psychological distress (HADS)Result — go to the resultLeast-squares mean difference −3.60 95% CI −5.73 to −1.47Authors' conclusion
This pilot randomized clinical trial supports the effectiveness and safety of a digital psychological intervention in individuals with IRDs.
Study context
- Population
- Adults (≥18 years) in Germany with RA, PsA or SLE reporting psychological distress and reduced quality of life92 [90.2%] female
- Participants
- 102 adults
- Comparison
- Self-guided digital psychological intervention vs treatment as usual
- Interventionn = 52
- Controln = 50reference
- Primary endpoint
- Co-primary: change in psychological distress (German HADS) and quality of life (AQoL-8D)
- Follow-up
- 3 months
Methodological detailspilot
- Pilot
Primary result
Change in psychological distress (HADS)
Least-squares mean difference
−3.60
95% CI −5.73 to −1.47
P < 0.001
Interventionvs Control
least-squares mean difference −3.60 (95% CI −5.73 to −1.47); P < 0.001
As reported in the abstract
Secondary outcomes
| Outcome | Least-squares mean difference (95% CI) | P value | |
|---|---|---|---|
| Co-primary: change in quality of life (AQoL-8D) · 3 monthsSE 0.02; Cohen d = 0.49 | 0.04 (0.00–0.09) | P = 0.047 | |
| −0.0500.050.1Difference (linear scale) |
Clinically meaningful improvement in psychological distress
P = 0.02
Clinically meaningful improvement in quality of life
P = 0.03
Secondary outcomes (self-efficacy, health literacy, perceived stress, functional impairment, depression, anxiety)
- Similar pattern of improvement, except for functional impairment
Safety
Adverse events related to the intervention
- None reported
Original publication
Digital Psychological Intervention for Inflammatory Rheumatic Diseases: A Pilot Randomized Clinical Trial. JAMA Netw Open. Published 2 September 2025. doi:10.
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