Neurobiological Underpinnings to Hypersexual Disorder

Neurobiologisk Bakgrund Till Hypersexuell Störning

Hypersexual Disorder (HD), sometimes called "sexual addiction", is a disorder with intense sexual desires and psychological preoccupations that lead to out-of-control sexual activities with severe consequences. HD is related to higher risks of HIV infection and an important risk factor for committing sexual crimes. The prevalence of HD is 3-6% of the general population, thus, a significant burden for society. The neurobiological mechanisms behind HD are still unknown, and there is still a great need for causal treatments.

This study is aimed at identifying neurobiological and psychological mechanisms underlying HD as a basis for treatment development. The overall goal is to improve mental health, quality of life, diagnosis and treatment options for affected individuals, and to reduce the impact HD can have on society. Patients with HD will be recruited at Karolinska University Hospital in close collaboration between endocrinologists, psychologists, psychiatrists, and brain researchers at Karolinska Institutet. Cases and healthy controls will undergo brain scans (MRI), psychological and blood tests to quantify neurobiological, cognitive, and behavioral aspects of HD.

This study is directly integrated into clinical practice, can identify important targets for interventions and factors predicting treatment outcomes. This study is essential for a better understanding of HD, the improvement of treatments, and can have significant impact on the prevention of HIV infections and sexual crimes.

Study Overview

• Status: Completed
• Conditions: Hypersexuality; Hypersexual Disorder; Compulsive Sexual Behavior
• Intervention / Treatment: Other: Brain Imaging; Other: Cognitive testing; Other: Psychometric; Other: Blood test

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 113 64
    • Karolinska University Hospital (ANOVA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Patients will be recruited through an ongoing CBT study (KAFKA_IT) at Karolinska University Hospital (ANOVA). Initial contact between patients and study coordinators will primarily be made through the phone helpline PrevenTell, designed to prevent sexual offences by targeting persons at risk. At the clinical visit patients will be evaluated in a face to face interview by trained psychologists/psychiatrists to establish psychiatric diagnoses, including the diagnosis of HD. If criteria for HD are met, patients will be informed about the present imaging study. Healthy controls from the Stockholm catchment area will be recruited through Karolinska Trial Alliance, and/or public advertisement in form of posters, online job postings and/or social media.

Description

Inclusion Criteria:

• Male
• At least 18 years of age,
• Fluent in the Swedish language
• Patients will meet diagnostic criteria for hypersexual disorder and will not have started with any psychotherapy or psychological treatment.
• Controls will be physically and psychologically healthy, and show no indication of clinical hypersexuality

Exclusion Criteria:

For both patients and controls any reported medical or clinical condition known to affect brain structure and function, test performance, or associated with risks for the MRI environment will be exclusionary. The investigators will exclude for the following:

• Severe neurological/psychiatric diseases or conditions (e.g., major depression, bipolar disorder, ADHD, autism, anxiety/panic disorder, obsessive compulsive disorder, personality disorder, Parkinson's disease, epilepsy, PTSD/chronic stress/burnout syndrom, Alzheimer's disease)
• Gender identity disorder/gender dysphoria
• Chronic pain conditions
• Impared vision, or other vision problems that cannot be corrected with MR-safe equipment.
• Hearing impairments, or problems with other senses
• History of severe brain damage/injuries
• Claustrophobia
• Having metal implants, a pacemaker, metallic braces or other MRI contra-indications
• Alcohol/drug dependence/abuse, eating disorder, pathological gambling, during the past 6 months.
• HIV and Hepatitis C/B, if the condition is untreated or virus levels detectable.
• Untreated endocrinologic diseases
• Medication: bensodiazepine, antipsychotics, mood stabilizers, centrally acting sympathicomimetics, SSRI (if use started less than 3 months ago). Any medication or pharmaceutical drug that interferes with sex hormone production or metabolism, i.e. ketoconazol, cyproteronacetate, spironolactone and similar drugs.

Note: There is a potentially higher prevalence of comorbidities and medication use in patients. To facilitate recruitment and study completion, the investigators may include subjects that report specific conditions at the discretion of the principle investigator. In those cases, corresponding information will be recorded in order to control for potential confounders.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Controls (HC); Controls will be physically and psychologically healthy and will show no indication of clinical hypersexuality.	Other: Brain Imaging; Structural MRI (T1 weighted); Diffusion Tensor Imaging (DTI); resting state functional MRI (rs-fMRI); functional MRI (fMRI): Brain activity will be measured in response to sexual images (visually evoked sexual arousal; processing of sexual stimuli), and importantly during a phase when these stimuli are anticipated (neural correlates of wanting and desire; reward anticipation).; Other: Cognitive testing; We will administer neuropsychological tests assessing objective measures for; intelligence (Ravens Matrices); impulsivity and risk-taking behavior (Balloon Analogue Risk Task); inhibitory control (Stop Signal Task).; Other: Psychometric; Administered questionnaires include anxiety and depression symptoms (MADRS, HADS, GAD), drug use (AUDIT, DUDIT), attention deficits (ASRS), impulsivity (BIS-11), reward seeking behavior (BIS/BAS), sexual orientation, (hyper)sexual behavior, desire and compulsivity aspects (HDSI, HBI, SCS, SDI, SIS/SES).; Other: Blood test; Blood samples will be taken for routine health assessment, measurement of sex hormonal levels, HPA-axis function test (dexamethasone suppression), and potential DNA extraction and (epi)genetic profiling.
Patients with hypersexual disorder (HD); Patients will meet diagnostic criteria for HD as defined in the DSM-5 proposed criteria for hypersexual disorder (Kafka, 2010) and CSBD according to ICD-11.	Other: Brain Imaging; Structural MRI (T1 weighted); Diffusion Tensor Imaging (DTI); resting state functional MRI (rs-fMRI); functional MRI (fMRI): Brain activity will be measured in response to sexual images (visually evoked sexual arousal; processing of sexual stimuli), and importantly during a phase when these stimuli are anticipated (neural correlates of wanting and desire; reward anticipation).; Other: Cognitive testing; We will administer neuropsychological tests assessing objective measures for; intelligence (Ravens Matrices); impulsivity and risk-taking behavior (Balloon Analogue Risk Task); inhibitory control (Stop Signal Task).; Other: Psychometric; Administered questionnaires include anxiety and depression symptoms (MADRS, HADS, GAD), drug use (AUDIT, DUDIT), attention deficits (ASRS), impulsivity (BIS-11), reward seeking behavior (BIS/BAS), sexual orientation, (hyper)sexual behavior, desire and compulsivity aspects (HDSI, HBI, SCS, SDI, SIS/SES).; Other: Blood test; Blood samples will be taken for routine health assessment, measurement of sex hormonal levels, HPA-axis function test (dexamethasone suppression), and potential DNA extraction and (epi)genetic profiling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain activity	Functional brain response (BOLD activity) upon presentation and anticipation of visual sexual stimuli.	acquired during brain imaging experiment (MRI scan day)
Anatomical brain measures	Measures for brain morphology (regional cortical volume, thickness, surface area, and subcortical volumes)	Acquired during brain imaging experiment (MRI scan day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting state fMRI	Functional connectivity	Acquired during fMRI experiment (MRI scan day)
Diffusion MRI	Structural connectivity	Acquired during fMRI experiment (MRI scan day)
Reaction times	Response reaction times during fMRI task	Acquired during fMRI experiment (MRI scan day)
Raven Progressive Matrices (cognitive task)	Objective measures for intelligence	Acquired at brain MRI assessment day, or as close to this day as possible.
Balloon Analogue Risk Task (cognitive task)	Objective measures for impulsivity/risk-taking	Acquired at brain MRI assessment day, or as close to this day as possible.
Stop Signal Task (cognitive task)	Objective measures for inhibitory control	Acquired at brain MRI assessment day, or as close to this day as possible.
MADRS-S (questionnaire)	Montgomery Asberg Depression Rating Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
ASRS (questionnaire)	Adult ADHD Self-Report Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
AUDIT (questionnaire)	Alcohol Use Disorders Identification Test	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
DUDIT (questionnaire)	Drug Use Disorders Identification Test	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
EQ-5D (questionnaire)	General Health information	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
4-item Kinsey-scale (questionnaire)	Sexual Orientation Dimension	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
HDSI (questionnaire)	Hypersexual Disorder Screening Inventory	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
SCS (questionnaire)	Sexual Compulsivity Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
HBI (questionnaire)	Hypersexual Behavior Inventory	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
SIS/SES (questionnaire)	Sexual Inhibition/Excitation Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
HADS (questionnaire)	Hospital Anxiety and Depression Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
GAD (questionnaire)	General Anxiety Disorder scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
BRSI-SE (questionnaire)	Bem Sex Role Inventory	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
RAADS (questionnaire)	Ritvo Autism Asperger Diagnostic Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
SDI (questionnaire)	Sexual Desire Inventory	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
BIS-11 (questionnaire)	Barratt Impulsiveness Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
BIS/BAS (questionnaire)	Behavioral Inhibition/Activation System	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Sexual Behavior (questionnaire)	Frequency of pornography consumption and sexual encounters.	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
fMRI experience rating (questionnaire)	Ratings of emotions experienced in context of the fMRI task, incl. craving/desire, stimuli induced sexual arousal.	Assessed right before and after MRI scan

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital, ANOVA, Stockholm (Stefan Arver, Katarina Görts Öberg)

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2017/2152-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No