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Recruiting NCT05861752

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

Observational Paraphilic Disorders Sexual Addiction Parasomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Treatment as usual.
Who it may be relevant to
Registry conditions: Paraphilic Disorders, Sexual Addiction, Parasomnia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Detailed description

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.

To answer question 1d (progress description), we will conduct qualitative interviews with 20 persons with sexual deviations. Those participating in this qualitative interview will provide written consent. The interview will take approximately 60 minutes, will be recorded, transcribed, and analyzed qualitatively.

To answer questions 2 and 3, we will after 3, 6 and 12 months note the type of treatment being given (e.g., Cognitive behavioral therapy or pharmacological), the number of completed visits and the number of interrupted treatments.

Treatment is also followed up with questionnaires.

Questionnaires/assessments used in the project:

The Achenbach System of Empirically Based Assessment (ASEBA)

Personality Inventory for DSM-5 (PID-5)

Montgomery Åsberg Depression Rating Scale (MADRS-S)

Ritvo Autism and Asperger Diagnostic Scale - Screening Tool (RAADS-14).

The Adult ADHD Self-Report Scale - Screen (ASRS-v1.1 Part A).

The Alcohol Use Disorders Identification Test (AUDIT)

The Drug Use Disorders Identification Test (DUDIT).

Childhood Trauma Questionnaire - Short Form (CTQ-SF)

Barratt Impulsiveness Scale (BIS).

The Brief version of the Difficulties in emotional regulation scale (DERS-16)

Brunnsviken Brief Quality of Life Inventory (BBQ)

Revised University of California (UCLA) Loneliness Scale (RULS)

Perceived Social Support (PSS-14)

Perceived Stress Scale (PSS)

Karolinska Interpersonal Violence Scale (KIVS)

Hypersexual Disorder Current assessment scale (HD:CAS)

Compulsive sexual behavior disorder scale (CSBD-19)

Rape scale

Hypersexual Behavior Inventory (HBI)

Client Satisfaction Questionnaire (CSQ-8)

Susceptibility to Temptation Scale (STS)

Långström Self-assessment of Sexual Interests (LASSIE)

Insomnia Severity Index (ISI)

Karolinska sleep questionnaire (KSQ)

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)

Interventions

  • Behavioral Treatment as usual
    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

Primary outcome measures

  • Karolinska interpersonal violence scale [Time frame: Baseline]
Secondary outcome measures (12)
  • structured evaluation of psychiatric symptoms [Time frame: Baseline]
  • Långström Self-assessment Sexual Interests (LASSIE) [Time frame: At baseline.]
  • Personality Inventory for DSM-5 (PID-5) [Time frame: At baseline.]
  • Achenbach System of Empirically Based Assessment [Time frame: At baseline.]
  • Hypersexual Disorder: Current Assessment Scale (HD:CAS) [Time frame: At baseline, and after 3, 6 and 12 months for each individual.]
  • The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S) [Time frame: At baseline, and after 3, 6 and 12 months for each individual.]
  • The Barratt Impulsiveness Scale (BIS) [Time frame: At baseline.]
  • Compulsive Sexual Behavior Disorder Scale-19 (CSBD-19) [Time frame: At baseline, and after 3, 6 and 12 months for each individual.]
  • The Rape questionnaire (Bumpy 1996). [Time frame: At baseline, and after 3, 6 and 12 months for each individual.]
  • Susceptibility to Temptation Scale (STS) [Time frame: At baseline.]
  • Insomnia Severity Index (ISI) [Time frame: At baseline, and after 3, 6 and 12 months for each individual with sexsomnia.]
  • The Difficulties in Emotion Regulation Scale (DERS) [Time frame: At baseline, and after 3, 6 and 12 months for each individual.]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Sweden · 1 center
  • Josephine Savard — Stockholm

Identifiers

NCT: NCT05861752 · 2022-00430-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗