Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study

NCT05861752 | Recruiting DMC

• 1 other identifier: 2022-00430-01
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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).

Conditions

Paraphilic Disorders; Sexual Addiction; Parasomnia

Outcome Measures

Primary Outcomes (1)

• Karolinska interpersonal violence scale

  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.

  Baseline

Secondary Outcomes (32)

• The Mini International Neuropsychiatric interview (MINI)

  At baseline.

• Långström Self-assessment Sexual Interests (LASSIE)

  At baseline.

• Personality Inventory for DSM-5 (PID-5)

  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.

Study Arms (2)

Clinical cohort

Patients seeking treatment with Paraphilic disorders, compulsive sexual behavior disorder and/or sexsomnia. These will be explored separately within each condition. For procedures, see the Detailed description heading

Behavioral: Treatment as usual

Healthy controls

Sex- and age-matched controls will be recruited through special research units, and through advertising on e.g. in newspapers, websites and on social media. If the person gives written consent, a structured medical assessment is carried out including assessment of psychiatric co-morbidity and medical history. The control person will then answer the same questionnaires as the research subjects in the clinical population. They also will be tested regarding impulsivity and provide blood samples.

Interventions

Treatment as usual BEHAVIORAL

both groups will undergo a psychiatric assessment including interviews, impulsivity tests and fill out questionnaires and leave blood samples. The clinical population will be followed regarding treatment as usual

Clinical cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical population: persons seeking treatment at the ANOVA clinic with indication of paraphilic disorder, Compulsive sexual behavior disorder or sexsomnia

You may qualify if:

• 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)

You may not qualify if:

• 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:
• Age and sex matched to clinical population
• Signed informed consent
• Be able to understand the Swedish language in oral and in writing
• 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.

Sponsors & Collaborators

• Region Stockholm: lead
• Umeå University: collaborator

Study Sites (1)

Josephine Savard

Stockholm, Stockholm County, 171 76, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We intend to analyze gene variation and epigenetic markers in genes that are related to epigenetic aging and neuroendocrine systems and that may be presumed to have a relationship to aberrant sexual behavior

MeSH Terms

Conditions

Paraphilic Disorders; Compulsive Sexual Behavior Disorder; Parasomnias

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Sexual and Gender Disorders; Sexual Dysfunctions, Psychological; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Josephine Savard, MD, PhD

  Anova, Karolinska University Hospital, Stockholm, Sweden.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josephine Savard

CONTACT

468123 73 200; josephine.savard@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 17, 2023
• Study Start: October 19, 2022
• Primary Completion (Estimated): October 19, 2027
• Study Completion (Estimated): October 19, 2037
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

SE (1)