Paraphilic DisordersNCT05861752
Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study
An observational study of Paraphilic Disorders and Sexual Addiction, run by Region Stockholm at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Paraphilic Disorders, Sexual Addiction, Parasomnia
- What is being tested?
- Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- 1 siteSweden
- Study dates
- 19 Oct 2022to 19 Oct 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clinical population: persons seeking treatment at the ANOVA clinic with indication of paraphilic disorder, Compulsive sexual behavior disorder or sexsomnia
Who may be able to join
- 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)
- Age and sex matched to clinical population
- Signed informed consent
- Be able to understand the Swedish language in oral and in writing
Who cannot join
- 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:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Josephine Savard
Stockholm, Stockholm County, 171 76
Josephine Savard, +46812373200, josephine.savard@regionstockholm.se
About this 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?
Read more
(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).
Read the 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)
- Conditions
- Paraphilic Disorders, Sexual Addiction, Parasomnia
- Being tested
- Treatment as usual
- Medical subject headings
- Paraphilic Disorders, Compulsive Sexual Behavior Disorder, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usualBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Clinical cohort | 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 Receives: Behavioral: Treatment as usual | |
| Healthy controls | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (30)
structured evaluation of psychiatric symptoms
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.
Measured: Baseline
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
Measured: At baseline.
Personality Inventory for DSM-5 (PID-5)
is a self-assessment of personality-related traits and problems in different domains.
Measured: At baseline.
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.
Measured: At baseline.
Hypersexual Disorder: Current Assessment Scale (HD:CAS)
Symptoms of hypersexual disorder. Score range is 0-24. A higher score indicates more severe problems.
Measured: At baseline, and after 3, 6 and 12 months for each individual.
The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S)
Score range is 0-54. A higher score indicates more severe problems.
Measured: At baseline, and after 3, 6 and 12 months for each individual.
The Barratt Impulsiveness Scale (BIS)
Score range is 30-120. A higher score indicates more severe problems.
Measured: At baseline.
Compulsive Sexual Behavior Disorder Scale-19 (CSBD-19)
Score range is 19-76. A higher score indicates more severe problems.
Measured: At baseline, and after 3, 6 and 12 months for each individual.
The Rape questionnaire (Bumpy 1996).
Assessment of cognitive distortions about sex. Score range is 36-144. A higher score indicates more severe problems.
Measured: At baseline, and after 3, 6 and 12 months for each individual.
Susceptibility to Temptation Scale (STS)
Score range is 11-55. A higher score indicates more severe problems.
Measured: At baseline.
Insomnia Severity Index (ISI)
Score range is 0-28. A higher score indicates more severe problems.
Measured: At baseline, and after 3, 6 and 12 months for each individual with sexsomnia.
The Difficulties in Emotion Regulation Scale (DERS)
Score range is 16-80. A higher score indicates more severe problems.
Measured: At baseline, and after 3, 6 and 12 months for each individual.
Brunnsviken Brief Quality of Life Inventory (BBQ)
Score range is 0-48. A higher score indicates high quality of life
Measured: At baseline, and after 3, 6 and 12 months for each individual.
Client Satisfaction Scale -8 (CSQ-8)
Score range is 8-32. A higher score indicates higher treatment satisfaction
Measured: At baseline, and after 3, 6 and 12 months for each individual.
Revised University of California (UCLA) Loneliness Scale (RULS)
Score range is 20-80. A higher score indicates more loneliness.
Measured: At baseline, and after 3, 6 and 12 months for each individual.
Karolinska Sleep Questionnaire (KSQ)
Score range is 13-65. A higher score indicates more severe problems.
Measured: At baseline, and after 3, 6 and 12 months for each individual with sexsomnia.
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.
Measured: Collected at baseline.
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.
Measured: At baseline,and after 3, 6 and 12 months for each individual.
The Alcohol Use Disorders Identification Test (AUDIT)
Total score range 0-40, ≥ 8 indicates harmful use.
Measured: At baseline.
The Drug Use Disorders Identification Test (DUDIT)
Total score range 0-44, ≥ 6 indicates harmful use.
Measured: At baseline.
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.
Measured: At baseline.
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)
Measured: At baseline.
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.
Measured: At baseline, and after 3, 6 and 12 months for each individual.
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
Measured: At baseline.
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.
Measured: At baseline.
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.
Measured: At baseline and after 3, 6 and 12 months for each individual. (For research question 1c: within 6 years)
Qualitative interview (Research question 1d)
A 60 min interview focusing on the disorder progress from first memory to current state.
Measured: within 6 years
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.
Measured: Registration at baseline and after 3, 6 and 12 months for each individual
Sociodemographic factors
Age, education level, country of origin, gender identity, relationship status, residence, living condition, offspring, employment, sexual orientation, medical treatment
Measured: At baseline (part of clinical evaluation)
Conviction of sexual offence (Research question 3)
Convictions in the Swedish offence register
Measured: After 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start19 Oct 2022
- Primary completion19 Oct 2027 (estimated)
- Study completion19 Oct 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraphilic DisordersStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Umeå University
- Responsible party
- Principal investigator, Josephine Savard, Region Stockholm
- Investigators
- Josephine Savard, MD, PhD, Principal investigator, Anova, Karolinska University Hospital, Stockholm, Sweden.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861752
- Sponsor's protocol ID
- 2022-00430-01
- Status last verified
- May 2026
- First submitted
- 3 May 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participants' data that underlie the results of the published article, after deidentification (text, tables, figures and appendices) might be available to researches who provide a methodically sound proposal.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study
- ClinicalTrials.gov ID
- NCT05861752
- Acronym / sponsor ID
- 2022-00430-01
- Conditions
- Paraphilic Disorders, Sexual Addiction, Parasomnia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Umeå University
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 19 Oct 2027 (estimated)
- Study completion
- 19 Oct 2037 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical cohort | – | Behavioral: Treatment as usualPatients 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 |
| Healthy controls | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical population: persons seeking treatment at the ANOVA clinic with indication of paraphilic disorder, Compulsive sexual behavior disorder or sexsomnia
Key inclusion criteria (7 listed)
- 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)
- Age and sex matched to clinical population
Key exclusion criteria (8 listed)
- 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).
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usualboth 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 | Behavioural | Clinical cohort |
Primary outcome
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.
30 secondary outcomes
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.
Brunnsviken Brief Quality of Life Inventory (BBQ)
Time frame: At baseline, and after 3, 6 and 12 months for each individual.
Client Satisfaction Scale -8 (CSQ-8)
Time frame: At baseline, and after 3, 6 and 12 months for each individual.
Revised University of California (UCLA) Loneliness Scale (RULS)
Time frame: At baseline, and after 3, 6 and 12 months for each individual.
Karolinska Sleep Questionnaire (KSQ)
Time frame: At baseline, and after 3, 6 and 12 months for each individual with sexsomnia.
DNA/epigenetic markers associated with sexual violence
Time frame: Collected at baseline.
The Hypersexual Behavior Inventory (HBI)
Time frame: At baseline,and after 3, 6 and 12 months for each individual.
The Alcohol Use Disorders Identification Test (AUDIT)
Time frame: At baseline.
The Drug Use Disorders Identification Test (DUDIT)
Time frame: At baseline.
The Childhood Trauma Questionnaire - short form (CTQ-SF)
Time frame: At baseline.
Computerized testing of impulsivity Cambridge Gambling Task (CGT) and Stop Signal Task (SST)
Time frame: At baseline.
Perceived Social Support: (PSS)
Time frame: At baseline, and after 3, 6 and 12 months for each individual.
Adult ADHD Self-Report Scale (ASRS)
Time frame: At baseline.
Ritvo Autism and Asperger Diagnostic Scale - Screening Tool (RAADS-14)
Time frame: At baseline.
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)
Qualitative interview (Research question 1d)
Time frame: within 6 years
Description of treatment as usual (Research question 2)
Time frame: Registration at baseline and after 3, 6 and 12 months for each individual
Sociodemographic factors
Time frame: At baseline (part of clinical evaluation)
Conviction of sexual offence (Research question 3)
Time frame: After 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided. Individual participants' data that underlie the results of the published article, after deidentification (text, tables, figures and appendices) might be available to researches who provide a methodically sound proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Josephine Savard, MD, PhD principal investigator
Anova, Karolinska University Hospital, Stockholm, Sweden.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paraphilic Disorders and Sexual Addiction, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josephine Savard (468123 73 200, josephine.savard@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Karolinska interpersonal violence scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.