About this trial
The ESPARA study is a multicenter observational research project aiming to monitor, over a three-year period, the evolution of sexual symptoms in male sexual offenders with paraphilia, divided into three groups: receiving antiandrogen treatment, receiving selective serotonin reuptake inhibitors (SSRIs), or no pharmacological treatment. The primary objective is to assess changes in sexual desire intensity and deviant sexual behaviors, while secondary objectives include relapse rates, the role of psychiatric comorbidities, treatment tolerability, and various clinical, cognitive, and life-history factors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men suffering from paraphilias (DSM-5 criteria),
Aged 18 to 65 years,
Sexual offenders (offense or sexual assault including exhibitionism, rape, sexual touching, incest, possession of pedopornographic video material) (severity level 1 to 6 according to WFSBP recommendations),
Subject who has given consent,
Disqualifiers
Subject in prison (regardless of the reason),
Subject under guardianship (patients under legal supervision may, however, be included),
Subjects who have committed a sexual offense and do not meet the DSM-5 criteria for paraphilia."
Trial population
* Men suffering from paraphilic disorders (DSM-5 criteria), * Aged between 18 and 65 years, * Sexual offenders (offense or sexual assault including exhibitionism, rape, sexual touching, incest, possession of child pornographic video material) (severity level 1 to 6 according to WFSBP guidelines)
Trial design
Cohort
Prospective
Treatments tested in this trial
For subjects on SSRIs: bone densitometry
RadiationFor subjects on SSRIs: Bone densitometry is one of the additional examinations considered. This assessment is part of the routine monitoring for subjects on androgens.
Treatment groups
Trial outcomes
Primary outcomes
Change in sexual desire and paraphilic behavior scores using the Intensity of Sexual Desire and Sexual Symptoms Scale (ISDSS, self-report)
The ISDSS assesses three domains of sexual functioning during the past month: Sexual interest and desire (score 0-8; higher = stronger desire) Sexual thoughts and fantasies (score 0-8; higher = more frequent/intense fantasies) Frequency of paraphilic sexual activities per week (e.g., masturbation, sexual activity leading to orgasm; reported as count). The mean score of the three domains (range 0-8) will be calculated. Higher scores indicate worse outcome (greater intensity/frequency of paraphilic sexual behavior).
Secondary outcomes
Sexual relapse occurrence
Number of participants with sexual relapse (recurrence of deviant sexual behavior) during the 36-month follow-up, recorded at each 3-month visit via participant report, third-party notifications, or official records.
Presence of psychiatric disorders according to DSM-5 criteria
Categorical diagnosis (present/absent) of psychiatric comorbidities assessed at baseline and 36 months using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
Change in treatment adherence - Brief Adherence Rating Scale
Outcome: Change from baseline in treatment adherence score at 36 months. Measurement: Measured every 3 months using the Brief Adherence Rating Scale (BARS, range 0-6; higher scores indicate better adherence).
Treatment-related adverse events
Number of participants with treatment-related adverse events during the 36-month follow-up, documented by type, frequency, onset time, and severity, as reported by the treating physician or participant.
Locations
Sponsors and contacts
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