Clinical trial NCT05861752: Paraphilic Disorders and Other Conditions with Risk for Sexual Violence: a Case-control Study
Official title: Paraphilic Disorders and Other Conditions with Risk for Sexual Violence: a Case-control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Paraphilic Disorders
Sexual Addiction
Parasomnia
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Umeå University
First posted: 2023-05-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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).

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 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)

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.

Primary outcomes:
measure: Karolinska interpersonal violence scale
timeFrame: Baseline
Secondary outcomes:
measure: The Mini International Neuropsychiatric interview (MINI)
timeFrame: At baseline.
measure: Långström Self-assessment Sexual Interests (LASSIE)
timeFrame: At baseline.
measure: Personality Inventory for DSM-5 (PID-5)
timeFrame: At baseline.
measure: Achenbach System of Empirically Based Assessment
timeFrame: At baseline.
measure: Hypersexual Disorder: Current Assessment Scale (HD:CAS)
timeFrame: At baseline, and after 3, 6 and 12 months for each individual.
measure: The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S)
timeFrame: At baseline, and after 3, 6 and 12 months for each individual.
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline, and after 3, 6 and 12 months for each individual.
measure: The Barratt Impulsiveness Scale (BIS)
timeFrame: At baseline.
measure: Compulsive Sexual Behavior Disorder Scale-19 (CSBD-19)
timeFrame: At baseline, and after 3, 6 and 12 months for each individual.
measure: The Rape questionnaire (Bumpy 1996).
timeFrame: At baseline, and after 3, 6 and 12 months for each individual.
measure: Susceptibility to Temptation Scale (STS)
timeFrame: At baseline.
measure: Insomnia Severity Index (ISI)
timeFrame: At baseline, and after 3, 6 and 12 months for each individual with sexsomnia.
measure: The Difficulties in Emotion Regulation Scale (DERS)
timeFrame: At baseline, and after 3, 6 and 12 months for each individual.
measure: Brunnsviken Brief Quality of Life Inventory (BBQ)
timeFrame: At baseline, and after 3, 6 and 12 months for each individual.
measure: Client Satisfaction Scale -8 (CSQ-8)
timeFrame: At baseline, and after 3, 6 and 12 months for each individual.
measure: Revised University of California (UCLA) Loneliness Scale (RULS)
timeFrame: At baseline, and after 3, 6 and 12 months for each individual.
measure: Karolinska Sleep Questionnaire (KSQ)
timeFrame: At baseline, and after 3, 6 and 12 months for each individual with sexsomnia.
measure: DNA/epigenetic markers associated with sexual violence
timeFrame: Collected at baseline.
measure: The Hypersexual Behavior Inventory (HBI)
timeFrame: At baseline,and after 3, 6 and 12 months for each individual.
measure: The Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: At baseline.
measure: The Drug Use Disorders Identification Test (DUDIT)
timeFrame: At baseline.
measure: The Childhood Trauma Questionnaire - short form (CTQ-SF)
timeFrame: At baseline.
measure: Computerized testing of impulsivity Cambridge Gambling Task (CGT) and Stop Signal Task (SST)
timeFrame: At baseline.
measure: Perceived Stress Scale: (PSS-14)
timeFrame: At baseline.
measure: Perceived Social Support: (PSS)
timeFrame: At baseline, and after 3, 6 and 12 months for each individual.
measure: Adult ADHD Self-Report Scale (ASRS)
timeFrame: At baseline.
measure: Ritvo Autism and Asperger Diagnostic Scale - Screening Tool (RAADS-14)
timeFrame: At baseline.
measure: 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)
timeFrame: At baseline and after 3, 6 and 12 months for each individual. (For research question 1c: within 6 years)
measure: Qualitative interview (Research question 1d)
timeFrame: within 6 years
measure: Description of treatment as usual (Research question 2)
timeFrame: Registration at baseline and after 3, 6 and 12 months for each individual
measure: Sociodemographic factors
timeFrame: At baseline (part of clinical evaluation)
measure: Conviction of sexual offence (Research question 3)
timeFrame: After 10 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Josephine Savard
Study officials:
affiliation: Anova, Karolinska University Hospital, Stockholm, Sweden.
name: Josephine Savard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: