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

Region Stockholm

Status: Enrolling

Conditions: Parasomnia; Paraphilic Disorders; Sexual Addiction

Treatments: Behavioral: Treatment as usual

Study type: Observational

Funder types: Other

Identifiers

NCT05861752

2022-00430-01

Details and patient eligibility

About

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).

Full 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 include the Mini International Neuropsychiatric Interview (MINI 7.0) and evaluation by a psychologist that focus on the persons 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)

Hospital Anxiety and Depression Scale (HADS)

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)

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

240 participants in 2 patient groups

Clinical cohort

Description:

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

Treatment:

Behavioral: Treatment as usual

Healthy controls

Description:

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.