Effectiveness of a digital health application (levidex) on quality of life in people with multiple sclerosis: A pragmatic, randomized controlled trial (LAMONT).

BACKGROUND: People with multiple sclerosis (pwMS) often experience impaired quality of life (QoL) despite receiving standard care. Digital therapeutics (DTx) may offer support, but prior trials yielded mixed results, possibly due to active controls and high baseline QoL. OBJECTIVES: We evaluated a DTx (levidex) as an adjunct to treatment as usual (TAU) in pwMS with impaired QoL. METHODS: In this pragmatic, online randomized controlled trial (LAMONT; NCT06090305), n = 470 pwMS with a score ≥ 2 on the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) were randomized to levidex + TAU or TAU alone. The primary endpoint was HAQUAMS total score at 6 months, analysed by intention-to-treat analysis of covariance. RESULTS: Compared with TAU, levidex + TAU improved multiple sclerosis-specific QoL at 6 months (baseline-adjusted mean difference -0.10; 95% CI -0.18 to -0.03; p = 0.008; Cohen's d = 0.26). Clinically relevant HAQUAMS improvement (≥0.22) occurred more often with levidex (39.5% vs. 27.8%; number needed to treat = 9). Benefits also emerged for depressive symptoms and social/work functioning but not for anxiety. No serious adverse events occurred, and user satisfaction was high. CONCLUSIONS: In pwMS with impaired QoL, adding the scalable DTx levidex to TAU yields meaningful improvements in QoL and functioning.