E-Mergir: A Digital Psychosexual Intervention for the Promotion of Mental and Sexual Health of Prostate Cancer Survivors

NCT07754929 | Recruiting

• 3 other identifiers: 2023.05157.BDUID/00050/2025NORTE-01-0145-FEDER-000057
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

prostate cancer; sexual health; mental health; e-Health; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (6)

• Global Measure of Sexual Satisfaction

  Questionnaire to assess sexual satisfaction

  Change from baseline sexual satisfaction over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.

• Sexual Pleasure Scale

  Questionnaire to assess sexual pleasure

  Change from baseline sexual pleasure over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.

• Female Sexual Distress Scale-Revised

  Questionnaire to assess sexual distress

  Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.

• The World Health Organization Quality of Life - Brief Version

  Questionnaire to assess general quality of life

  Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.

• The Brief Symptom Inventory

  Questionnaire to assess psychological distress

  Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.

• The Five Facet Mindfulness Questionnaire

  Questionnaire to assess ability for mindfulness

  Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.

Secondary Outcomes (5)

• International Index of Erectile Function

  Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.

• Global Measure of Relational Satisfaction

  Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.

• The Sexual Dysfunctional Beliefs Questionnaire

  Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.

• Sexual Modes Questionnaire

  Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.

• Posttraumatic Growth Inventory

  Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.

Study Arms (2)

Experimental: testing the digital intervention

EXPERIMENTAL

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.

Device: E-Mergir

Waiting list group: waiting to access the intervention after an eight-week waiting period.

NO INTERVENTION

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.

Interventions

E-Mergir DEVICE

e-Health intervention to promote mental and sexual health of prostate cancer survivors. An online psychological intervention (e-Health app technology) specifically tailored to meet the needs of Portuguese men with prostate cancer was developed to promote participants' mental and sexual health. The intervention protocol was designed under the principles of Cognitive Behavior Therapy (CBT), featuring psychological and sexual health promotion strategies. The intervention program consists of 5 modules covering components of psychoeducation, sexual rehabilitation, mindfulness, cognitive restructuring, and relapse prevention. The modules will be delivered online (using text, videos, and graphics) along with therapeutic support provided by a certified Clinical Psychologist, over an eight-week period.

Experimental: testing the digital intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate cancer survivors,
• years old or older,
• Ability to give informed consent,
• Regular use of a smartphone and internet access.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto

Porto, Portugal

RECRUITING

Related Publications (4)

• Bossio 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 BACKGROUND

• Pieramico, 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

  BACKGROUND

• Siddons 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 BACKGROUND

• Pieramico 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 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Personal Satisfaction; Behavior

Central Study Contacts

Ana Luísa Quinta Gomes, PhD

CONTACT

+351965816335; bisagomes@gmail.com

Sonia Pieramico, MSc

CONTACT

soniapieramico@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: August 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)