Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Karolinska interpersonal violence scale
研究概览
简要总结
The goal of this case-control study is to compare clinical characteristics in help-seeking individuals with paraphilic disorders or sexsomnia (sexual behaviors during sleep- a diagnosis in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5)), as compared to healthy controls. The main questions this study aims to answer are:
(1a) Is there a difference in experience of violence between the clinical population and healthy controls? Is there a difference between the clinical groups?
(1b) What are the clinical characteristics of these conditions (psychiatric, sociodemographic, and genetic/epigenetic factors)? Does the clinical population differ from healthy controls?
(1c) How are the psychometric properties of the assessment forms (primarily those addressing sexual deviance and compulsive sexuality) in the project?
(1d) How has sexual interest developed over time among patients with paraphilic disorders? (including the person's own description of e.g. triggers and expectations).
Follow-up of clinical population:
(2) What is the typical treatment as usual (TAU) for the patient population? (e.g., average length of care, the percentage of dropouts and what kind of treatment has been given) (3) Are there any factors at baseline (e.g., presence of neuropsychiatric symptoms, age, symptom burden) that predict treatment outcome? (i.e., symptom burden based on self-assessments at follow-up 3, 6 and 12 months from the start of treatment and records in offence registers after 10 years).
详细描述
After obtaining a written consent, a physician conducts a structured medical assessment including assessment of psychiatric co-morbidity and medical history.
The participant will thereafter answer questions about socio-demographic factors, sexual preference and relational status and answer questionnaires (see last section). Scales that address sleep are used on indication.
Continued assessment includes a structured evaluation of psychiatric symptoms according to DSM-5 criteria, as well as a psychological assessment focused on the individual's sexual behaviour.
The person will also undergo computerized neuropsychological testing of impulsivity and, if consent has been given, also provide a blood samples.
After the assessment phase (intake) we will evaluate psychiatric diagnoses and make a treatment plan.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age and older
- •Signed informed consent
- •Be able to understand the Swedish language in oral and in writing
- •Meet criteria for paraphilia (sexual deviation) according to DSM-5 (with the exception of pedophilia), compulsive sexual behavior disorder according to the International Classification of Diseases (ICD-11), or sexsomnia (sexual act during sleep)
排除标准
- •Serious mental disorder such as current psychosis or severe depression that requires immediate handling/treatment.
- •Psychological condition that may endanger the patient's health or the scientific parts of the study, this is assessed by the assessing physician and psychologist (for example, intellectual disability).
- •Criteria for control persons:
- •Inclusion criteria
- •Age and sex matched to clinical population
- •Signed informed consent
- •Be able to understand the Swedish language in oral and in writing
- •Exclusion criteria
- •Serious somatic illness (determined by the study physician).
- •Ongoing substance use syndrome
- •Serious psychiatric illnesses/conditions that require medical attention (determined by the study physician).
- •First-degree relative with schizophrenia, bipolar disorder or deceased by suicide.
- •Positive screening for compulsive sexual behavior disorder, paraphilia or sexsomnia.
结局指标
主要结局
Karolinska interpersonal violence scale
时间窗: Baseline
the outcome measure for main question (1a) is the Karolinska interpersonal violence scale (KIVS) that measures exposure to and use of violence. The Karolinska Interpersonal Violence Scale contains 4 rating scales assessing exposure to violence and expressed violent behavior in childhood (between 6-14 years of age) and during adult life (15 years or older). The subscales are scored 0-5. (Min = 0, Max= 20). Higher scores indicate more experience of violence.
次要结局
- Personality Inventory for DSM-5 (PID-5)(At baseline.)
- Client Satisfaction Scale -8 (CSQ-8)(At baseline, and after 3, 6 and 12 months for each individual.)
- The Mini International Neuropsychiatric interview (MINI)(At baseline.)
- Långström Self-assessment Sexual Interests (LASSIE)(At baseline.)
- Achenbach System of Empirically Based Assessment(At baseline.)
- Hypersexual Disorder: Current Assessment Scale (HD:CAS)(At baseline, and after 3, 6 and 12 months for each individual.)
- The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S)(At baseline, and after 3, 6 and 12 months for each individual.)
- The Hospital Anxiety and Depression Scale (HADS)(At baseline, and after 3, 6 and 12 months for each individual.)
- The Barratt Impulsiveness Scale (BIS)(At baseline.)
- Compulsive Sexual Behavior Disorder Scale-19 (CSBD-19)(At baseline, and after 3, 6 and 12 months for each individual.)
- The Rape questionnaire (Bumpy 1996).(At baseline, and after 3, 6 and 12 months for each individual.)
- Karolinska Sleep Questionnaire (KSQ)(At baseline, and after 3, 6 and 12 months for each individual with sexsomnia.)
- The Hypersexual Behavior Inventory (HBI)(At baseline,and after 3, 6 and 12 months for each individual.)
- The Alcohol Use Disorders Identification Test (AUDIT)(At baseline.)
- The Drug Use Disorders Identification Test (DUDIT)(At baseline.)
- The Childhood Trauma Questionnaire - short form (CTQ-SF)(At baseline.)
- Susceptibility to Temptation Scale (STS)(At baseline.)
- Insomnia Severity Index (ISI)(At baseline, and after 3, 6 and 12 months for each individual with sexsomnia.)
- The Difficulties in Emotion Regulation Scale (DERS)(At baseline, and after 3, 6 and 12 months for each individual.)
- Brunnsviken Brief Quality of Life Inventory (BBQ)(At baseline, and after 3, 6 and 12 months for each individual.)
- Revised University of California (UCLA) Loneliness Scale (RULS)(At baseline, and after 3, 6 and 12 months for each individual.)
- DNA/epigenetic markers associated with sexual violence(Collected at baseline.)
- Computerized testing of impulsivity Cambridge Gambling Task (CGT) and Stop Signal Task (SST)(At baseline.)
- Perceived Stress Scale: (PSS-14)(At baseline.)
- Perceived Social Support: (PSS)(At baseline, and after 3, 6 and 12 months for each individual.)
- Adult ADHD Self-Report Scale (ASRS)(At baseline.)
- Ritvo Autism and Asperger Diagnostic Scale - Screening Tool (RAADS-14)(At baseline.)
- Frotteuristic Disorder:Current Assessment Scale (FD: CAS), Voyeuristic Disorder: Current Assessment Scale (VD: CAS), Exhibitionistic Disorder: Current Assessment Scale (ED: CAS), Coercive Sexual Sadism Disorder: Current Assessment Scale (CSSD: CAS)(At baseline and after 3, 6 and 12 months for each individual. (For research question 1c: within 6 years))
- Qualitative interview (Research question 1d)(within 6 years)
- Conviction of sexual offence (Research question 3)(After 10 years)
- Description of treatment as usual (Research question 2)(Registration at baseline and after 3, 6 and 12 months for each individual)
- Sociodemographic factors(At baseline (part of clinical evaluation))
研究者
Josephine Savard
Principal Investigator
Region Stockholm