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

ConditionProstate Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18+

SponsorUniversidade do Porto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Prostate cancer survivors,

18 years old or older,

Ability to give informed consent,

Regular use of a smartphone and internet access.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

106 Participants

are divided into 2 treatment groups

Group A: Experimental: testing the digital interventionExperimental treatment 1 intervention

Group B: Waiting list group: waiting to access the intervention after an eight-week waiting period.No intervention 0 interventions

Trial outcomes

Primary outcomes

Global Measure of Sexual Satisfaction

Questionnaire to assess 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.

Sexual Pleasure Scale

Questionnaire to assess sexual pleasure

Time frame

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

Time frame