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, 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.

WB, AR, LTB and GAJ are employed by GAIA, the developer and manufacturer of the intervention described in the study. JPK received funding for clinical trials (German Federal Ministry of Health, Servier), payments for presentations on psychological internet interventions (GAIA, Oberberg, Servier, Stillachhaus), consulting fees from developers and distributors of psychological internet interventions (all about me, Boehringer, Ethypharm, GAIA, medac, sympatient) payments for workshops and books (Beltz, Elsevier, Hogrefe and Springer) on psychiatry, psychosomatics and psychotherapy. He is past president of the CBASP network (now DsG-CBASP) and serves as vice chairman of the chapters "Digital Psychiatry" and "Psychotherapy" of the German Psychiatric Association (DGPPN). JS and MB have no conflicts of interest to declare.

NCT06237166

This trial was funded by GAIA (Hamburg, Germany).

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The ethics committee of the Hamburg State Chamber of Physicians (Ärztekammer Hamburg) gave ethical approval for this work.

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