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Prostate CancerE-MergirNCT07754929

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

A study testing E-Mergir in people with Prostate Cancer, run by Universidade do Porto at 1 site in Portugal.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Prostate cancer (PCa) survivors frequently experience enduring psychosexual challenges following treatment, including sexual dysfunction, emotional distress, and reduced quality of life. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
E-Mergir
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 sitePortugal
Study dates
1 Jul 2026to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ana Luísa Quinta Gomes, PhD contact

+351965816335

bisagomes@gmail.com

Sonia Pieramico, MSc contact

soniapieramico@gmail.com

Portugal1 site, 1 recruiting
  • Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto

    Porto

    Ana Gomes, bisagomes@gmail.com

    Recruiting

Other trials in Portugal

About this study

Official title: 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

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.

Read the detailed description

This study was approved by the Ethical Board of Coimbra University Hospital. 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 Cognitive-Behavior Therapy (CBT) principles, 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 guidance and support provided by a certified Clinical Psychologist over eight weeks.

Participants will be recruited through medical doctors at the Urology department of Coimbra University Hospital and invited telephonically to participate in the present study. If the potential participant declares interest, a researcher will contact them telephonically to confirm the following inclusion criteria: i) bein a prostate cancer survivor; ii) 18 years old or older; iii) have the ability to give informed consent; iv) own a smartphone and have internet access; v) no other oncological diagnoses over the past five years, vi)no severe neurological or psychological disorders.

Participants will be randomly assigned to one of two conditions: 1) e-Health psychological intervention (n=53); 2) waiting list group, (n= 53). Participants will be clinically assessed before and after the intervention on different psychosexual dimensions (e.g., mental health, quality of life, sexual dysfunction). The experimental group is expected to improve regarding mental and sexual well-being outcomes compared to the control group. Furthermore, the experimental group is expected to show the program's acceptability. This study aims to inform a future a randomized control trial that aims to further test the e-Health intervention's efficacy. Pre, mid-term, (at 4 weeks) post-test, three-month and six-month follow-up assessments will be performed for both groups.

Primary outcomes: psychological distress, sexual distress, sexual satisfaction, sexual pleasure, mindfulness, and quality of life.

Secondary outcomes: Sexual function, relational satisfaction, sexual dysfunctional beliefs, and automatic thoughts.

Exploratory outcomes: post-traumatic growth All scales are validated and adapted to the Portuguese population. Furthermore, a semi-structured interview will be conducted with experimental group participants by the end of the study to collect further insight on how possible mental and sexual improvements were achieved.

Participants' data will be stored in an encrypted file, saved on a computer, and only accessible to the main researchers of this study. Confidentiality will be guaranteed by assigning an individual code to each participant. This code will be used to log into the digital intervention and complete psychometric scales. Interviews will be recorded and transcribed. Transcriptions will be marked with the same code to ensure the association of the collected data.

Statistical procedures will be performed using IBM SPSS and include i) descriptive analyses; ii) MANOVA to measure differences among groups and to compare assessment moments; iii) Multiple Regression Analysis to examine treatment predictors; iv) Structural Equation Modeling to illustrate the mechanisms by which improvement of mental and sexual health was achieved.

Conditions
Prostate Cancer
Being tested
E-Mergir
Keywords
prostate cancer, sexual health, mental health, e-Health, cognitive behavioral therapy
Medical subject headings
Prostatic Neoplasms, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E-MergirDevice

    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.

Study groups in NCT07754929
Study groupRoleWhat they receive
Experimental: testing the digital interventionExperimentalExperimental: 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.
Receives: Device: E-Mergir
Waiting list group: waiting to access the intervention after an eight-week waiting period.No interventionWaiting 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global Measure of Sexual Satisfaction

    Questionnaire to assess sexual satisfaction

    Measured: 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.

  2. Sexual Pleasure Scale

    Questionnaire to assess sexual pleasure

    Measured: 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.

  3. Female Sexual Distress Scale-Revised

    Questionnaire to assess sexual distress

    Measured: 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.

  4. The World Health Organization Quality of Life - Brief Version

    Questionnaire to assess general quality of life

    Measured: 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.

  5. The Brief Symptom Inventory

    Questionnaire to assess psychological distress

    Measured: 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.

  6. The Five Facet Mindfulness Questionnaire

    Questionnaire to assess ability for mindfulness

    Measured: 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)
  1. International Index of Erectile Function

    Questionnaire to assess erectile function

    Measured: 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.

  2. Global Measure of Relational Satisfaction

    Questionnaire to assess relational satisfaction

    Measured: 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.

  3. The Sexual Dysfunctional Beliefs Questionnaire

    Questionnaire to assess sexual dysfunctional beliefs

    Measured: 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.

  4. Sexual Modes Questionnaire

    A subscale of this questionnaire will be used to assess automatic thoughts

    Measured: 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.

  5. Posttraumatic Growth Inventory

    As an exploratory outcome we will use this questionnaire to assess post-traumatic growth

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start1 Jul 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07754929
Sponsor's protocol ID
2023.05157.BD
Other IDs
UID/00050/2025, NORTE-01-0145-FEDER-000057, 2023
Acronym
E-Mergir
Status last verified
Jul 2026
First submitted
18 Mar 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31029619
  • 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

  • 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.

    PubMed 23576518
  • 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.

    PubMed 37286525

Questions about this trial

What is this clinical trial studying?

A study testing E-Mergir in people with Prostate Cancer, run by Universidade do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ana Luísa Quinta Gomes, PhD (+351965816335, bisagomes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Measure of Sexual Satisfaction (time frame: 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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07754929, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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