Adherence, Acceptability, and Sexual Health Outcomes of the Odeya App–Based Intervention for Sexual Distress in Women With Endometriosis: Randomized Controlled Mixed Methods Trial

Background Evidence-based interventions effectively treat sexual dysfunctions. Up to 13.5% of women with gynecological conditions are affected, yet access to therapy is limited. Self-guided digital interventions may offer scalable, accessible first-line support. Objective This randomized controlled mixed methods pilot trial evaluated adherence, acceptance, and safety of the Odeya app and changes in sexual and health outcomes among women with sexual dysfunctions and endometriosis. Methods Following online and flyer-based recruitment, participants completed an online screening and were randomized to either an intervention group (IG) receiving 8 self-guided app modules targeting biopsychosocial aspects of sexuality or to a control group (CG) receiving routine care. Self-administered online questionnaires were completed at baseline (T0), midintervention (T1), postintervention (T2), and 6-month follow-up (T3). Standardized instruments assessed acceptance (Client Satisfaction Questionnaire-Internet CSQ-I and German mHealth App Usability Questionnaire G-MAUQ), safety (Inventory for the balanced assessment of Negative Effects of Psychotherapy-Online Intervention), sexual health (Female Sexual Distress Scale-Desire/Arousal/Orgasm FSDS-DAO, Female Sexual Function Index-German version FSFI-d, and Partnership Questionnaire), and overall health (Patient-Reported Outcome Measurement Information System-29-Item Profile, Beck Depression Inventory-II, and Generalized Anxiety Disorder-7). Adherence indicators included module completion, dropout rates, and symptom tracker use. Group differences were examined descriptively and using Cohen d. Qualitative data were collected through free-list questionnaires from dropouts (n=11) and interviews with completers (IG: n=3; CG: n=2). Results A total of 60 women (mean age 31.12, SD 6.67 years) with confirmed or suspected endometriosis and sexual distress (FSDS-DAO score >18) were randomized to the IG (n=29) or CG (n=31). IG participants completed on average 61.2% (4.9/8) of modules; the dropout rate was 65.5% (19/29). Emotional strain, time demands, and technical issues were key barriers causing dropout, while persona-based stories facilitated engagement. Participants wished for more professional interaction. IG completers (n=10, 34.5%) showed lower baseline depression and anxiety but higher sexual distress. Satisfaction was high (CSQ-I=26.60; G-MAUQ=5.38). Although some adverse health changes were reported, findings indicate safety. FSDS-DAO scores decreased in both groups, with mean reductions from baseline of −10.39, −12.61, and −14.98 in the IG and −3.68, −14.83, and −6.92 in the CG from T1 to T3, respectively. Moderate to large between-group effects favoring the IG were observed at T1 (d=−0.66) and T3 (d=−0.79). Sexual function (FSFI-d) improved only in the IG (T1-T3: d=0.16-1.00). Qualitative findings highlighted rediscovery of positive sexual experiences, improved communication, and increased openness. Both groups reported improvements in anxiety, depression, and physical functioning, with additional gains in emotion regulation, distress reduction, and body awareness reported in the IG. Women emphasized symptom complexity and a need for more professional guidance. Conclusions The self-guided intervention was well accepted and showed preliminary improvements among completers. Adherence and sustained engagement seemed shaped by baseline psychosocial health, pointing to a need for tailored adaptations and larger confirmatory trials. Trial Registration German Clinical Trials Register DRKS00034351; https://drks.de/search/en/trial/DRKS00034351