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NCT05861752
Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study
Conditions: Paraphilic Disorders, Sexual Addiction, Parasomnia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 240
Sponsor: Region Stockholm
Location: Josephine Savard Stockholm Stockholm County
Summary
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).
Eligibility Criteria
Inclusion Criteria:
1. 18 years of age and older
2. Signed informed consent
3. Be able to understand the Swedish language in oral and in writing
4. 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)
Exclusion Criteria:
1. Serious mental disorder such as current psychosis or severe depression that requires immediate handling/treatment.
2. 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
1. Age and sex matched to clinical population
2. Signed informed consent
3. Be able to understand the Swedish language in oral and in writing
Exclusion criteria
1. Serious somatic illness (determined by the study physician).
2. Ongoing substance use syndrome
3. Serious psychiatric illnesses/conditions that require medical attention (determined by the study physician).
4. First-degree relative with schizophrenia, bipolar disorder or deceased by suicide.
5. Positive screening for compulsive sexual behavior disorder, paraphilia or sexsomnia.
Source: ClinicalTrials.gov (NCT05861752). StuddyBuddy aggregates publicly available trial information.