Abstract
OBJECTIVE: Axial spondyloarthritis (axSpA) is often associated with persistent pain despite effective anti-inflammatory treatment. Digital health applications (DHAs) provide innovative approaches to address multidimensional aspects of persistent pain through psychological and behavioral strategies. The aim of this study was to assess the impact of a DHA using acceptance and commitment therapy (ACT) on disease outcomes, including the West Haven-Yale Multidimensional Pain Inventory (MPI), in patients with axSpA experiencing persistent pain despite stable pharmacological therapy. METHODS: This unblinded, multicentric, randomized controlled trial compared an intervention group (IG) receiving the ACT app with a standard of care (SOC) group. The ACT app provided behavioral therapy. The primary outcome was MPI pain-related life interference; secondary outcomes included pain severity, affective distress, and other patient-reported outcomes after 12 weeks. Linear models estimating the effect of the ACT app on the change of MPI pain-related life interference and affective distress were calculated. RESULTS: A total of 136 patients were randomized to IG (n = 73) with the ACT app and SOC (n = 63) without the ACT app. In the IG, 44 actively used the ACT app. All lessons in the ACT app were completed by 19 IG patients (43%). Baseline characteristics, including MPI scores, were comparable between groups. IG showed a reduction in pain-related life interference as well as in other outcomes. The improvements in pain-related life interference (β with -0.36, 95% confidence interval [CI]: -0.73 to 0.01) and affective distress related to the disease (-0.4; 95% CI -0.84 to 0.03) were greater compared with SOC. CONCLUSION: The ACT app demonstrated a meaningful reduction in pain-related life interference, supporting that DHAs might become a complementary tool in managing pain for patients with axSpA. Studies about improving adherence to DHAs are warranted.