Clinical trial · Interventional
E-Mergir: A Digital Psychosexual Intervention for the Promotion of Mental and Sexual Health of Prostate Cancer Survivors
E-Mergir: a Randomized Controlled Trial to Test the Efficacy of a Digital Psychosexual Intervention for the Promotion of Mental and Sexual Health of Prostate Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prostate cancer (PCa) survivors frequently experience enduring psychosexual challenges following treatment, including sexual dysfunction, emotional distress, and reduced quality of life. Despite these difficulties, access to tailored support remains limited, highlighting the need for scalable and accessible alternatives such as digital interventions. This study presents the protocol for a randomized controlled trial (RCT) evaluating the effectiveness of E-Mergir, a digital psychosexual intervention developed for PCa survivors. Grounded in cognitive behavioral therapy (CBT) and mindfulness strategies, the intervention aims to enhance both sexual and mental well-being. The trial employs a wait-list control design with randomized allocation. Participants will complete assessments at baseline, post-intervention, and follow-up, using validated measures related to sexual outcomes (sexual satisfaction, pleasure, function, distress, and beliefs) and mental health outcomes (quality of life, anxiety, depression, mindfulness, relationship satisfaction, and automatic thoughts). The study aims to determine whether E-Mergir is an effective digital intervention for improving psychosexual outcomes in PCa survivors, compared to a wait-list control group. It also aims to examine treatment predictors to illustrate the mechanisms through which improvements in mental and sexual health are achieved. If effective, E-Mergir could address a critical gap in supportive care for PCa survivors and serve as a model for culturally tailored digital psychosexual interventions globally.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E-Mergir | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: testing the digital intervention
- description
- Experimental: testing the digital intervention. Prostate cancer survivors (n=53) randomly assigned to this arm will complete a digital psychosexual intervention and will be accompanied weekly by a certified clinical psychologist to monitor progress (synchronous or asynchronous). Pre- midterm (4 weeks into intervention) and post testing involve questionnaires collecting data on psychosexual variables. At post-testing a 30-minute interview will be conducted to collect information on how possible mental and sexual health improvements were achieved.
- interventionNames
- Device: E-Mergir
- type
- NO_INTERVENTION
- label
- Waiting list group: waiting to access the intervention after an eight-week waiting period.
- description
- Waiting list group: waiting to access the intervention after an eight-week waiting period. Prostate cancer survivors (n=53) randomly assigned to this arm will not be accompanied or get access to the intervention during the eight week period in which the experimental group is completing the intervention. Pre- midterm and post testing involve questionnaires collecting data on psychosexual variables. After post testing the waiting-list arm will gain access to the intervention.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate cancer survivors, * 18 years old or older, * Ability to give informed consent, * Regular use of a smartphone and internet access. Exclusion Criteria: * Other diagnosed oncological diseases over the past five years, * Severe neurological impairment or other severe psychological/psychiatric diseases (depression, generalized anxiety disorder, psychosis-related disorders), * Other uncontrolled/unstable diseases, * Severe hearing and/or visual impairment, * Under psychotherapy or treatment for sexual problems, * Participating concurrently in other clinical trials.
References
Publications (4)
- BACKGROUNDBossio JA, Miller F, O'Loughlin JI, Brotto LA. Sexual Health Recovery For Prostate Cancer Survivors: The Proposed Role Of Acceptance And Mindfulness-Based Interventions. Sex Med Rev. 2019 Oct;7(4):627-635. doi: 10.1016/j.sxmr.2019.03.001. Epub 2019 Apr 24. PMID 31029619
- BACKGROUNDPieramico, S., Rocha, H., & Quinta-Gomes, A. L. (2025). E-MERGIR: a QUALITATIVE STUDY ON ACCEPTABILITY AND USABILITY OF a DIGITAL PSYCHOSEXUAL INTERVENTION FOR PROSTATE CANCER SURVIVORS. The Journal of Sexual Medicine, 22(Supplement_2). https://doi.org/10.1093/jsxmed/qdaf077.132
- BACKGROUNDSiddons HM, Wootten AC, Costello AJ. A randomised, wait-list controlled trial: evaluation of a cognitive-behavioural group intervention on psycho-sexual adjustment for men with localised prostate cancer. Psychooncology. 2013 Oct;22(10):2186-92. doi: 10.1002/pon.3273. Epub 2013 Apr 10. PMID 23576518
- BACKGROUNDPieramico S, Castro R, Aguiar S, Bismarck F, Ferreira D, Carvalho J, Quinta Gomes AL, Nobre P. A systematic review on the efficacy of CBT interventions for the mental and sexual health of survivors of prostate cancer. Sex Med Rev. 2023 Dec 23;12(1):48-58. doi: 10.1093/sxmrev/qead024. PMID 37286525