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

4. August 2026 aktualisiert von: Ana Luísa de Matos Dias Quinta Gomes, Universidade do Porto

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

106

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Portugal
      • Porto, Portugal
        • Rekrutierung
        • Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Experimental: testing the digital intervention
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.
Gerät: E-Mergir
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.
Kein Eingriff: Waiting list group: waiting to access the intervention after an eight-week waiting period.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Global Measure of Sexual Satisfaction
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
International Index of Erectile Function
Zeitfenster: 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.
Questionnaire to assess 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
Zeitfenster: 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.
Questionnaire to assess 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
Zeitfenster: 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.
Questionnaire to assess sexual dysfunctional beliefs
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
Zeitfenster: 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.
A subscale of this questionnaire will be used to assess automatic thoughts
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
Zeitfenster: 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.
As an exploratory outcome we will use this questionnaire to assess post-traumatic growth
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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universidade do Porto

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

18. März 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. August 2026

Zuerst gepostet (Tatsächlich)

10. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. August 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2023.05157.BD
  • NORTE-01-0145-FEDER-000057 (Andere Zuschuss-/Finanzierungsnummer: Horizon 2020 - European Commission)
  • UID/00050/2025 (Andere Zuschuss-/Finanzierungsnummer: Fundação para a Ciência e Tecnolo[Portuguese Foundation for Science and Technology])

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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