Study on the Observation of the Evolution of Sexual Symptoms in Sexual Offenders With Paraphilia (With or Without Antiandrogen or SSRI Treatments)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Change in sexual desire and paraphilic behavior scores using the Intensity of Sexual Desire and Sexual Symptoms Scale (ISDSS, self-report)
研究概览
简要总结
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.
详细描述
This is a prospective longitudinal cohort study including 200 male participants aged 18-65 years, diagnosed with a paraphilic disorder according to DSM-5, and convicted of sexual offenses (e.g., exhibitionism, rape, sexual assault, incest, possession of child sexual abuse material). Participants are recruited in their usual care setting, after providing informed consent, and assigned to one of three cohorts based on current treatment: antiandrogens, SSRIs, or no pharmacological treatment.
Over a 3-year follow-up period, participants undergo standardized assessments every 3 months, including:
Measurement of sexual desire intensity and deviant sexual symptoms (validated self-report scales).
Recording of any relapses (self-reported, third-party notifications). Evaluation of psychiatric comorbidities (DSM-5), personality disorders (PDQ-4+), impulsivity (BIS-11), and treatment adherence (BARS).
Biological analyses (testosterone levels and others) and regular clinical examinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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,
- •Patients covered by social security,
- •Satisfactory command of written and spoken French."
排除标准
- •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."
结局指标
主要结局
Change in sexual desire and paraphilic behavior scores using the Intensity of Sexual Desire and Sexual Symptoms Scale (ISDSS, self-report)
时间窗: Baseline
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).
次要结局
- Sexual relapse occurrence(3 months)
- Presence of psychiatric disorders according to DSM-5 criteria(Baseline and 36 months.)
- Change in treatment adherence - Brief Adherence Rating Scale(3 months)
- Treatment-related adverse events(At baseline)
- Presence of clinically observable gynecomastia(3 months.)
- Traumatic life events (THQ - Trauma History Questionnaire)(At baseline)
- Change in clinical management - Comorbidity(3 months)
- Change in clinical management - Treatment tolerance(3 months)
- Change in clinical management - Sexual symptoms evolution(3 months)
- Change in treatment adherence - Serum testosterone level(At 36 months)
- Personality traits measured with the Personality Diagnostic Questionnaire-4+ (PDQ-4+)(Baseline and 36 months.)
- Impulsivity measured with the Barratt Impulsiveness Scale, Version 11 (BIS-11)(Baseline and 36 months.)
- Change in systolic and diastolic blood pressure (mmHg)(3 months.)
- Change in body weight (kg)(3 months.)
- Aggression measured with the Molest Scale(3 months.)
- Sexual violence risk measured with the Rape Scale(3 months.)
- Empathy score [specify full name of empathy scale](3 months.)
- Denial score [specify full name of denial scale](3 months.)
- Alcohol use measured with the Alcohol Use Disorders Identification Test (AUDIT)(3 months.)
- Illicit drug use (type, quantity, duration)(3 months.)
- Hypersexuality screening with PATHOS and PEACCE(3 months.)
- Compulsive sexual behavior measured with the Compulsive Sexual Behavior Inventory (CSBI)(3 months.)
- Sexual violence risk measured with the STATIC-99(3 months.)
- Sexual risk factors measured with the STABLE-2007(3 months.)
- Cognitive function measured with the Montreal Cognitive Assessment (MoCA)(Baseline)
- Cognitive flexibility measured with the Stroop Test(Baseline)