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NCT Number: NCT05861752

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

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).

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Key information

Conditions

Paraphilic Disorders Behavior Behavior, Addictive Compulsive Behavior Compulsive Sexual Behavior Disorder Impulsive Behavior Mental Disorders Nervous System Diseases Parasomnia Parasomnias Sexual Addiction Sexual Dysfunctions, Psychological Sexual and Gender Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Josephine Savard

Stockholm, Stockholm County, 171 76, Sweden

Location status: Recruiting

Location contact

Josephine Savard

CONTACT

[email protected]

+46812373200

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Karolinska interpersonal violence scale

    Time frame: Baseline

    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.

Secondary outcomes

  1. structured evaluation of psychiatric symptoms

    Time frame: Baseline

    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.

  2. Långström Self-assessment Sexual Interests (LASSIE)

    Time frame: At baseline.

    A self-assessment scale based on the diagnostic criteria for paraphilic disorders listed in Screening for paraphilic disorders in the DSM-5

  3. Personality Inventory for DSM-5 (PID-5)

    Time frame: At baseline.

    is a self-assessment of personality-related traits and problems in different domains.

  4. Achenbach System of Empirically Based Assessment

    Time frame: At baseline.

    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.

  5. Hypersexual Disorder: Current Assessment Scale (HD:CAS)

    Time frame: At baseline, and after 3, 6 and 12 months for each individual.

    Symptoms of hypersexual disorder. Score range is 0-24. A higher score indicates more severe problems.

  6. The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S)

    Time frame: At baseline, and after 3, 6 and 12 months for each individual.

    Score range is 0-54. A higher score indicates more severe problems.

  7. The Barratt Impulsiveness Scale (BIS)

    Time frame: At baseline.

    Score range is 30-120. A higher score indicates more severe problems.

  8. Compulsive Sexual Behavior Disorder Scale-19 (CSBD-19)

    Time frame: At baseline, and after 3, 6 and 12 months for each individual.

    Score range is 19-76. A higher score indicates more severe problems.

  9. The Rape questionnaire (Bumpy 1996).

    Time frame: At baseline, and after 3, 6 and 12 months for each individual.

    Assessment of cognitive distortions about sex. Score range is 36-144. A higher score indicates more severe problems.

  10. Susceptibility to Temptation Scale (STS)

    Time frame: At baseline.

    Score range is 11-55. A higher score indicates more severe problems.

  11. Insomnia Severity Index (ISI)

    Time frame: At baseline, and after 3, 6 and 12 months for each individual with sexsomnia.

    Score range is 0-28. A higher score indicates more severe problems.

  12. The Difficulties in Emotion Regulation Scale (DERS)

    Time frame: At baseline, and after 3, 6 and 12 months for each individual.

    Score range is 16-80. A higher score indicates more severe problems.

  13. Brunnsviken Brief Quality of Life Inventory (BBQ)

    Time frame: At baseline, and after 3, 6 and 12 months for each individual.

    Score range is 0-48. A higher score indicates high quality of life

  14. Client Satisfaction Scale -8 (CSQ-8)

    Time frame: At baseline, and after 3, 6 and 12 months for each individual.

    Score range is 8-32. A higher score indicates higher treatment satisfaction

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

    Time frame: At baseline, and after 3, 6 and 12 months for each individual.

    Score range is 20-80. A higher score indicates more loneliness.

  16. Karolinska Sleep Questionnaire (KSQ)

    Time frame: At baseline, and after 3, 6 and 12 months for each individual with sexsomnia.

    Score range is 13-65. A higher score indicates more severe problems.

  17. DNA/epigenetic markers associated with sexual violence

    Time frame: Collected at baseline.

    Whole blood (DNA-preparation): investigation of NR3C1, NR3C1, FKBP5, CRHR1, CRHR2, LHB, GNRHR, OXTR, CD38, OPRM1, OPRD1, OPRK1, and epigenetic age.

  18. The Hypersexual Behavior Inventory (HBI)

    Time frame: At baseline,and after 3, 6 and 12 months for each individual.

    a 19-item scale constructed to reflect the proposed DSM-5 criteria of hypersexual disorder. Score range is 19-95. A higher score indicates more severe problems.

  19. The Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: At baseline.

    Total score range 0-40, ≥ 8 indicates harmful use.

  20. The Drug Use Disorders Identification Test (DUDIT)

    Time frame: At baseline.

    Total score range 0-44, ≥ 6 indicates harmful use.

  21. The Childhood Trauma Questionnaire - short form (CTQ-SF)

    Time frame: At baseline.

    Consists of 28 items and measures different aspects of childhood abuse and neglect, each with 5 items. Subscale score range: 5-25. A score above 5 indicate experience of trauma/neglect.

  22. Computerized testing of impulsivity Cambridge Gambling Task (CGT) and Stop Signal Task (SST)

    Time frame: At baseline.

    From CANTAB® [Cognitive assessment software]. Cambridge Gambling Task (CGT) Stop Signal Task (SST)

  23. Perceived Social Support: (PSS)

    Time frame: At baseline, and after 3, 6 and 12 months for each individual.

    Two subscales, one addressing support from family and the other from friends. Score range is 20-80. A higher score indicates more severe problems.

  24. Adult ADHD Self-Report Scale (ASRS)

    Time frame: At baseline.

    A self-report screening scale of adult attention-deficit/hyperactivity disorder (ADHD) consisting of 18 questions about symptoms of adult ADHD. Each item is rated on a 5-point Likert scale with 0="never" and 4="very often". Part A (items 1-6) has four items of inattention and two items of hyperactivity/impulsivity, and could be used for screening

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

    Time frame: At baseline.

    The scale consists of 14 items and total score range from 0 to 42. A score of 14 indicate need for further assessment.

  26. 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)

    Time frame: At baseline and after 3, 6 and 12 months for each individual. (For research question 1c: within 6 years)

    The questionnaires are all scored 0-32. A higher score indicates more severe problems.

  27. Qualitative interview (Research question 1d)

    Time frame: within 6 years

    A 60 min interview focusing on the disorder progress from first memory to current state.

  28. Description of treatment as usual (Research question 2)

    Time frame: Registration at baseline and after 3, 6 and 12 months for each individual

    Registration if the participant is receiving cognitive behavioral therapy, pharmacological, psychoeducation, number of fulfilled treatments, average treatment duration.

  29. Sociodemographic factors

    Time frame: At baseline (part of clinical evaluation)

    Age, education level, country of origin, gender identity, relationship status, residence, living condition, offspring, employment, sexual orientation, medical treatment

  30. Conviction of sexual offence (Research question 3)

    Time frame: After 10 years

    Convictions in the Swedish offence register

Study contacts

Contact information is provided by the study sponsor or research team.

Josephine Savard

CONTACT

[email protected]

468123 73 200

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Umeå University

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2037
First posted
May 17, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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