NCT05861752 Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study
| NCT ID | NCT05861752 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Stockholm |
| Condition | Paraphilic Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2022-10-19 |
| Primary Completion | 2027-10-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2022-10-19 with a primary completion date of 2027-10-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Josephine Savard, MD, PhD
PRINCIPAL INVESTIGATOR
Anova, Karolinska University Hospital, Stockholm, Sweden.
Frequently Asked Questions
Who can join the NCT05861752 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paraphilic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05861752 currently recruiting?
Yes, NCT05861752 is actively recruiting participants. Contact the research team at josephine.savard@regionstockholm.se for enrollment information.
Where is the NCT05861752 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05861752 clinical trial?
NCT05861752 is sponsored by Region Stockholm. The principal investigator is Josephine Savard, MD, PhD at Anova, Karolinska University Hospital, Stockholm, Sweden.. The trial plans to enroll 240 participants.