JMIR Publications

ABSTRACT

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 for sexual distress.

Objective:

This randomized controlled mixed-methods pilot trial evaluated adherence, acceptance, safety, and changes in sexual and overall health outcomes of the Odeya app 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 eight self-guided app modules targeting biopsychosocial aspects of sexuality or to a control group (CG) receiving routine care. The trial employed self-administered online questionnaires at baseline (T0), mid-intervention (T1), post-intervention (T2), and 6-month follow-up (T3). Standardized instruments assessed acceptance (Client Satisfaction Questionnaire–Internet [CSQ-I], German mHealth App Usability Questionnaire [G-MAUQ]), safety (Inventory for the Assessment of Negative Effects in Psychotherapy [INEP-ON]), sexual health (Female Sexual Distress Scale–Desire/Arousal/Orgasm [FSDS-DAO], Female Sexual Function Index [FSFI-d], Partnership Questionnaire [PFB]), and overall health (Patient-Reported Outcomes Measurement Information System [PROMIS-29], Beck Depression Inventory-II [BDI-II], Generalized Anxiety Disorder-7 [GAD-7]). Adherence indicators included module completion, dropout rates, and symptom tracker use. Group differences were examined descriptively and using Cohen’s d. Qualitative data were collected through free-list questionnaires from dropouts (n = 11) and interviews with completers (IG n = 3, CG n = 2).

Results:

Sixty women (mean age = 31.12 years, SD = 6.67) with confirmed or suspected endometriosis and sexual distress (FSDS-DAO > 18) were randomized to the IG (n = 29) or CG (n = 31). IG participants completed on average 61.2% of modules; dropout rate was 65.5%. Emotional strain, time demands, and technical issues were key dropout barriers; persona-based stories facilitated engagement, and participants wished for more professional–patient 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 life or health changes were reported, overall 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 at T1–T3, respectively, corresponding to moderate-to-large between-group effects favoring the IG 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 data pointed to rediscovering positive sexual experiences, improved communication, and greater openness as engagement facilitators. Both groups reported improvements in anxiety, depression, and physical functioning, with the IG noting additional gains in emotion regulation, distress reduction, and body awareness. 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. Clinical Trial: German Clinical Trials Register DRKS00034351; https://drks.de/search/en/trial/DRKS00034351