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

Sexual Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861752
• Other study ID #: 2022-00430-01
• Status: Recruiting
• Start date: October 19, 2022
• Est. completion date: October 19, 2037

Study information

• Verified date: May 2023
• Source: Region Stockholm
• Contact: Josephine Savard
• Phone: 468123 73 200
• Email: josephine.savard[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 19, 2037
• Est. primary completion date: October 19, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parasomnia
• Parasomnias
• Sexual Addiction

Intervention

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

Locations

Country	Name	City	State
Sweden	Josephine Savard	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	The Mini International Neuropsychiatric interview (MINI)	a validated diagnostic structured interview to assess for mental disorders	At baseline.
Secondary	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	At baseline.
Secondary	Personality Inventory for DSM-5 (PID-5)	is a self-assessment of personality-related traits and problems in different domains.	At baseline.
Secondary	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.	At baseline.
Secondary	Hypersexual Disorder: Current Assessment Scale (HD:CAS)	Symptoms of hypersexual disorder. Score range is 0-24. A higher score indicates more severe problems.	At baseline, and after 3, 6 and 12 months for each individual.
Secondary	The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S)	Score range is 0-54. A higher score indicates more severe problems.	At baseline, and after 3, 6 and 12 months for each individual.
Secondary	The Hospital Anxiety and Depression Scale (HADS)	Score range is 0-21. A higher score indicates more severe problems.	At baseline, and after 3, 6 and 12 months for each individual.
Secondary	The Barratt Impulsiveness Scale (BIS)	Score range is 30-120. A higher score indicates more severe problems.	At baseline.
Secondary	Compulsive Sexual Behavior Disorder Scale-19 (CSBD-19)	Score range is 19-76. A higher score indicates more severe problems.	At baseline, and after 3, 6 and 12 months for each individual.
Secondary	The Rape questionnaire (Bumpy 1996).	Assessment of cognitive distortions about sex. Score range is 36-144. A higher score indicates more severe problems.	At baseline, and after 3, 6 and 12 months for each individual.
Secondary	Susceptibility to Temptation Scale (STS)	Score range is 11-55. A higher score indicates more severe problems.	At baseline.
Secondary	Insomnia Severity Index (ISI)	Score range is 0-28. A higher score indicates more severe problems.	At baseline, and after 3, 6 and 12 months for each individual with sexsomnia.
Secondary	The Difficulties in Emotion Regulation Scale (DERS)	Score range is 16-80. A higher score indicates more severe problems.	At baseline, and after 3, 6 and 12 months for each individual.
Secondary	Brunnsviken Brief Quality of Life Inventory (BBQ)	Score range is 0-48. A higher score indicates high quality of life	At baseline, and after 3, 6 and 12 months for each individual.
Secondary	Client Satisfaction Scale -8 (CSQ-8)	Score range is 8-32. A higher score indicates higher treatment satisfaction	At baseline, and after 3, 6 and 12 months for each individual.
Secondary	Revised University of California (UCLA) Loneliness Scale (RULS)	Score range is 20-80. A higher score indicates more loneliness.	At baseline, and after 3, 6 and 12 months for each individual.
Secondary	Karolinska Sleep Questionnaire (KSQ)	Score range is 13-65. A higher score indicates more severe problems.	At baseline, and after 3, 6 and 12 months for each individual with sexsomnia.
Secondary	DNA/epigenetic markers associated with sexual violence	Whole blood (DNA-preparation): investigation of NR3C1, NR3C1, FKBP5, CRHR1, CRHR2, LHB, GNRHR, OXTR, CD38, OPRM1, OPRD1, OPRK1, and epigenetic age.	Collected at baseline.
Secondary	The Hypersexual Behavior Inventory (HBI)	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.	At baseline,and after 3, 6 and 12 months for each individual.
Secondary	The Alcohol Use Disorders Identification Test (AUDIT)	Total score range 0-40, = 8 indicates harmful use.	At baseline.
Secondary	The Drug Use Disorders Identification Test (DUDIT)	Total score range 0-44, = 6 indicates harmful use.	At baseline.
Secondary	The Childhood Trauma Questionnaire - short form (CTQ-SF)	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.	At baseline.
Secondary	Computerized testing of impulsivity Cambridge Gambling Task (CGT) and Stop Signal Task (SST)	From CANTAB® [Cognitive assessment software]. Cambridge Gambling Task (CGT) Stop Signal Task (SST)	At baseline.
Secondary	Perceived Stress Scale: (PSS-14)	Score range is 0-56. A higher score indicates more severe problems.	At baseline.
Secondary	Perceived Social Support: (PSS)	Two subscales, one addressing support from family and the other from friends. Score range is 20-80. A higher score indicates more severe problems.	At baseline, and after 3, 6 and 12 months for each individual.
Secondary	Adult ADHD Self-Report Scale (ASRS)	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	At baseline.
Secondary	Ritvo Autism and Asperger Diagnostic Scale - Screening Tool (RAADS-14)	The scale consists of 14 items and total score range from 0 to 42. A score of 14 indicate need for further assessment.	At baseline.
Secondary	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)	The questionnaires are all scored 0-32. A higher score indicates more severe problems.	At baseline and after 3, 6 and 12 months for each individual. (For research question 1c: within 6 years)
Secondary	Qualitative interview (Research question 1d)	A 60 min interview focusing on the disorder progress from first memory to current state.	within 6 years
Secondary	Description of treatment as usual (Research question 2)	Registration if the participant is receiving cognitive behavioral therapy, pharmacological, psychoeducation, number of fulfilled treatments, average treatment duration.	Registration at baseline and after 3, 6 and 12 months for each individual
Secondary	Sociodemographic factors	Age, education level, country of origin, gender identity, relationship status, residence, living condition, offspring, employment, sexual orientation, medical treatment	At baseline (part of clinical evaluation)
Secondary	Conviction of sexual offence (Research question 3)	Convictions in the Swedish offence register	After 10 years