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

Selina Marie Kronthaler, Eden Kosman, Tatjana Tissen-Diabaté, Elena Mühle, Luzia Weber- Schallauer, Therese Pross, Maria Margarete Karsten, Klaus Michael Beier, Dr Laura Hatzler
2025 · doi:10.2196/preprints.86042 · W7130587890
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⚙ AI-generated summary by gemini-2.5-flash-lite, 2026-06-07 ⓘ

This randomized trial found the Odeya app intervention was well-accepted and showed preliminary improvements in sexual health among women with endometriosis who completed the program.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-07 · read from full text ⓘ

This randomized controlled mixed-methods pilot trial evaluated the app-based, self-guided “Odeya” intervention for sexual distress in women with confirmed or suspected endometriosis, comparing eight modules plus questionnaires (baseline, mid, post, and 6-month follow-up) against routine care after online and flyer-based recruitment. Among 60 participants randomized to the intervention (n=29) or control (n=31), the intervention group completed on average 61.2% of modules but had a 65.5% dropout rate driven by emotional strain, time demands, and technical issues; although acceptance and safety measures were generally favorable, the paper limits interpretation due to the pilot design, small numbers (qualitative completers/interviewees), and high attrition. Quantitatively, Female Sexual Distress Scale–Desire/Arousal/Orgasm scores decreased in both groups, with larger between-group improvements favoring Odeya at mid and 6 months, and sexual function (FSFI-d) improved only in the intervention group. Relevance to endometriosis: the study is centrally about endometriosis-related sexual distress and tests the Odeya app in women with confirmed or suspected endometriosis.

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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. 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. CLINICALTRIAL German Clinical Trials Register DRKS00034351; https://drks.de/search/en/trial/DRKS00034351
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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 Citation Request queued. Please wait while the file is being generated. It may take some time. Copyright © The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.

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endometriosis

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