[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505466":3},{"organization":4,"outcomesModule":7,"designInfo":115,"detailedDescription":118,"studyPopulation":119,"armGroups":120,"interventions":129,"overallOfficials":135,"centralContacts":140,"locations":146,"responsibleParty":163,"collaborators":165,"id":169,"slug":114,"hasResults":170,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":114,"eligibilityCriteria":173,"healthyVolunteers":174,"sex":175,"minAge":176,"maxAge":114,"enrollmentInfo":177,"targetDuration":114,"studyType":180,"phases":114,"briefSummary":181,"conditions":182,"keywords":114,"overallStatus":148,"whyStopped":114,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"fullName":5,"class":6},"Region Stockholm","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":114},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,21,24,27,31,34,37,40,43,46,50,53,56,59,62,65,69,73,76,79,82,85,88,91,94,98,102,106,110],{"measure":15,"description":16,"timeFrame":12},"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.\n\nThe assessment covers psychiatric history, current symptoms, functional impairment, and relevant psychosocial factors.\n\nClinical 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.",{"measure":18,"description":19,"timeFrame":20},"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.",{"measure":22,"description":23,"timeFrame":20},"Personality Inventory for DSM-5 (PID-5)","is a self-assessment of personality-related traits and problems in different domains.",{"measure":25,"description":26,"timeFrame":20},"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.",{"measure":28,"description":29,"timeFrame":30},"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.",{"measure":32,"description":33,"timeFrame":30},"The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S)","Score range is 0-54. A higher score indicates more severe problems.",{"measure":35,"description":36,"timeFrame":20},"The Barratt Impulsiveness Scale (BIS)","Score range is 30-120. A higher score indicates more severe problems.",{"measure":38,"description":39,"timeFrame":30},"Compulsive Sexual Behavior Disorder Scale-19 (CSBD-19)","Score range is 19-76. A higher score indicates more severe problems.",{"measure":41,"description":42,"timeFrame":30},"The Rape questionnaire (Bumpy 1996).","Assessment of cognitive distortions about sex. Score range is 36-144. A higher score indicates more severe problems.",{"measure":44,"description":45,"timeFrame":20},"Susceptibility to Temptation Scale (STS)","Score range is 11-55. A higher score indicates more severe problems.",{"measure":47,"description":48,"timeFrame":49},"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.",{"measure":51,"description":52,"timeFrame":30},"The Difficulties in Emotion Regulation Scale (DERS)","Score range is 16-80. A higher score indicates more severe problems.",{"measure":54,"description":55,"timeFrame":30},"Brunnsviken Brief Quality of Life Inventory (BBQ)","Score range is 0-48. A higher score indicates high quality of life",{"measure":57,"description":58,"timeFrame":30},"Client Satisfaction Scale -8 (CSQ-8)","Score range is 8-32. A higher score indicates higher treatment satisfaction",{"measure":60,"description":61,"timeFrame":30},"Revised University of California (UCLA) Loneliness Scale (RULS)","Score range is 20-80. A higher score indicates more loneliness.",{"measure":63,"description":64,"timeFrame":49},"Karolinska Sleep Questionnaire (KSQ)","Score range is 13-65. A higher score indicates more severe problems.",{"measure":66,"description":67,"timeFrame":68},"DNA\u002Fepigenetic 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.",{"measure":70,"description":71,"timeFrame":72},"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.",{"measure":74,"description":75,"timeFrame":20},"The Alcohol Use Disorders Identification Test (AUDIT)","Total score range 0-40, ≥ 8 indicates harmful use.",{"measure":77,"description":78,"timeFrame":20},"The Drug Use Disorders Identification Test (DUDIT)","Total score range 0-44, ≥ 6 indicates harmful use.",{"measure":80,"description":81,"timeFrame":20},"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\u002Fneglect.",{"measure":83,"description":84,"timeFrame":20},"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)",{"measure":86,"description":87,"timeFrame":30},"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.",{"measure":89,"description":90,"timeFrame":20},"Adult ADHD Self-Report Scale (ASRS)","A self-report screening scale of adult attention-deficit\u002Fhyperactivity 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\u002Fimpulsivity, and could be used for screening",{"measure":92,"description":93,"timeFrame":20},"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.",{"measure":95,"description":96,"timeFrame":97},"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)",{"measure":99,"description":100,"timeFrame":101},"Qualitative interview (Research question 1d)","A 60 min interview focusing on the disorder progress from first memory to current state.","within 6 years",{"measure":103,"description":104,"timeFrame":105},"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",{"measure":107,"description":108,"timeFrame":109},"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)",{"measure":111,"description":112,"timeFrame":113},"Conviction of sexual offence (Research question 3)","Convictions in the Swedish offence register","After 10 years",null,{"allocation":114,"interventionModel":114,"interventionModelDescription":114,"primaryPurpose":114,"observationalModel":116,"timePerspective":117,"maskingInfo":114},"CASE_CONTROL","CROSS_SECTIONAL","After obtaining a written consent, a physician conducts a structured medical assessment including assessment of psychiatric co-morbidity and medical history.\n\nThe 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.\n\nContinued 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.\n\nThe person will also undergo computerized neuropsychological testing of impulsivity and, if consent has been given, also provide a blood samples.\n\nAfter the assessment phase (intake) we will evaluate psychiatric diagnoses and make a treatment plan.\n\nTo 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.\n\nTo 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.\n\nTreatment is also followed up with questionnaires.\n\nQuestionnaires\u002Fassessments used in the project:\n\nThe Achenbach System of Empirically Based Assessment (ASEBA)\n\nPersonality Inventory for DSM-5 (PID-5)\n\nMontgomery Åsberg Depression Rating Scale (MADRS-S)\n\nRitvo Autism and Asperger Diagnostic Scale - Screening Tool (RAADS-14).\n\nThe Adult ADHD Self-Report Scale - Screen (ASRS-v1.1 Part A).\n\nThe Alcohol Use Disorders Identification Test (AUDIT)\n\nThe Drug Use Disorders Identification Test (DUDIT).\n\nChildhood Trauma Questionnaire - Short Form (CTQ-SF)\n\nBarratt Impulsiveness Scale (BIS).\n\nThe Brief version of the Difficulties in emotional regulation scale (DERS-16)\n\nBrunnsviken Brief Quality of Life Inventory (BBQ)\n\nRevised University of California (UCLA) Loneliness Scale (RULS)\n\nPerceived Social Support (PSS-14)\n\nPerceived Stress Scale (PSS)\n\nKarolinska Interpersonal Violence Scale (KIVS)\n\nHypersexual Disorder Current assessment scale (HD:CAS)\n\nCompulsive sexual behavior disorder scale (CSBD-19)\n\nRape scale\n\nHypersexual Behavior Inventory (HBI)\n\nClient Satisfaction Questionnaire (CSQ-8)\n\nSusceptibility to Temptation Scale (STS)\n\nLångström Self-assessment of Sexual Interests (LASSIE)\n\nInsomnia Severity Index (ISI)\n\nKarolinska sleep questionnaire (KSQ)\n\nFrotteuristic 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)","Clinical population: persons seeking treatment at the ANOVA clinic with indication of paraphilic disorder, Compulsive sexual behavior disorder or sexsomnia",[121,126],{"label":122,"type":114,"description":123,"interventionNames":124},"Clinical cohort","Patients seeking treatment with Paraphilic disorders, compulsive sexual behavior disorder and\u002For sexsomnia. These will be explored separately within each condition.\n\nFor procedures, see the Detailed description heading",[125],"Behavioral: Treatment as usual",{"label":127,"type":114,"description":128,"interventionNames":114},"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.\n\nIf the person gives written consent, a structured medical assessment is carried out including assessment of psychiatric co-morbidity and medical history.\n\nThe 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.",[130],{"type":131,"name":132,"description":133,"armGroupLabels":134,"otherNames":114},"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",[122],[136],{"name":137,"affiliation":138,"role":139},"Josephine Savard, MD, PhD","Anova, Karolinska University Hospital, Stockholm, Sweden.","PRINCIPAL_INVESTIGATOR",[141],{"name":142,"role":143,"phone":144,"phoneExt":114,"email":145},"Josephine Savard","CONTACT","468123 73 200","josephine.savard@regionstockholm.se",[147],{"facility":142,"status":148,"city":149,"state":150,"zip":151,"country":152,"countryCode":153,"cosmosGeoPoint":154,"geoPoint":159,"contacts":160},"RECRUITING","Stockholm","Stockholm County","171 76","Sweden","SE",{"type":155,"coordinates":156},"Point",[157,158],18.06871,59.32938,{"lat":158,"lon":157},[161],{"name":142,"role":143,"phone":162,"phoneExt":114,"email":145},"+46812373200",{"type":139,"investigatorFullName":142,"investigatorTitle":164,"investigatorAffiliation":5,"oldNameTitle":114,"oldOrganization":114},"Principal Investigator",[166],{"name":167,"class":168},"Umeå University","OTHER","100505466",false,"NCT05861752","Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study","Inclusion Criteria:\n\n1. 18 years of age and older\n2. Signed informed consent\n3. Be able to understand the Swedish language in oral and in writing\n4. 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)\n\nExclusion Criteria:\n\n1. Serious mental disorder such as current psychosis or severe depression that requires immediate handling\u002Ftreatment.\n2. 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).\n\nCriteria for control persons:\n\nInclusion criteria\n\n1. Age and sex matched to clinical population\n2. Signed informed consent\n3. Be able to understand the Swedish language in oral and in writing\n\nExclusion criteria\n\n1. Serious somatic illness (determined by the study physician).\n2. Ongoing substance use syndrome\n3. Serious psychiatric illnesses\u002Fconditions that require medical attention (determined by the study physician).\n4. First-degree relative with schizophrenia, bipolar disorder or deceased by suicide.\n5. Positive screening for compulsive sexual behavior disorder, paraphilia or sexsomnia.",true,"ALL","18 Years",{"count":178,"type":179},240,"ESTIMATED","OBSERVATIONAL","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:\n\n(1a) Is there a difference in experience of violence between the clinical population and healthy controls? Is there a difference between the clinical groups?\n\n(1b) What are the clinical characteristics of these conditions (psychiatric, sociodemographic, and genetic\u002Fepigenetic factors)? Does the clinical population differ from healthy controls?\n\n(1c) How are the psychometric properties of the assessment forms (primarily those addressing sexual deviance and compulsive sexuality) in the project?\n\n(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).\n\nFollow-up of clinical population:\n\n(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).",[183,184,185],"Paraphilic Disorders","Sexual Addiction","Parasomnia","2026-06-02",{"date":188,"type":189},"2026-06-04","ACTUAL",{"date":191,"type":189},"2022-10-19",{"date":193,"type":179},"2037-10-19",{"name":5,"class":6},1]