Digital intervention mylovia improves sexual functioning in women with sexual dysfunction in randomized controlled trial.

Given the widespread issue of female sexual dysfunction and the scarcity of treatment options, novel therapeutic approaches are needed. This randomized controlled trial evaluated the use of mylovia©, a self-guided digital intervention for female sexual dysfunction and sexual pain disorder based on CBT and mindfulness, in addition to treatment as usual (TAU) compared to TAU plus information material. 252 women participated. At three months, the intervention group showed significantly greater improvements (Cohen's d = 0.51, p < 0.001) in sexual functioning, measured by the Female Sexual Function Index (FSFI), with effects maintained at six months. Clinical relevance was confirmed by Reliable Change Index (RCI) responder analysis. The intervention group also reported greater improvements in sexual desire, satisfaction, and pain-related cognitions and behaviors. There were no significant between-group differences in depressive symptoms or adverse events. The intervention demonstrated comparable efficacy to existing psychosocial treatments, offering a digital therapeutic that could narrow the current gender healthcare gap. This trial was registered on ClinicalTrials.gov on 24 January 2024, with the identifying number NCT06237166.