Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegion Stockholm
About this trial
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
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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).
Age and sex matched to clinical population
Signed informed consent
Trial population
Clinical population: persons seeking treatment at the ANOVA clinic with indication of paraphilic disorder, Compulsive sexual behavior disorder or sexsomnia
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Treatment as usual
Behavioralboth 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
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Clinical cohort1 intervention
Group B: Healthy controls0 interventions
Trial outcomes
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.
Time frame
BaselineSecondary outcomes
1
structured evaluation of psychiatric symptoms
A psychiatric assessment will be conducted using a semi-structured clinical interview routinely applied at the ANOVA clinic. The interview is performed by a specialist in psychiatry and is based on established clinical practice. The assessment covers psychiatric history, current symptoms, functional impairment, and relevant psychosocial factors. Clinical diagnoses will be established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Diagnostic conclusions are based on the clinician's overall evaluation, integrating information from the interview and, when applicable, additional clinical data.
Time frame
Baseline2
Långström Self-assessment Sexual Interests (LASSIE)
A self-assessment scale based on the diagnostic criteria for paraphilic disorders listed in Screening for paraphilic disorders in the DSM-5
Time frame
At baseline.3
Personality Inventory for DSM-5 (PID-5)
is a self-assessment of personality-related traits and problems in different domains.
Time frame
At baseline.4
Achenbach System of Empirically Based Assessment
a self-report questionnaire for adults screening for e.g., behavioural problems. Each item is not directly correlated with a specific scale, instead the assessments recognize patterns of syndromes.
Time frame
At baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Stockholm
Lead sponsor
Umeå University
Collaborator
Source ClinicalTrials.gov