<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04448405</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0341</org_study_id>
    <nct_id>NCT04448405</nct_id>
  </id_info>
  <brief_title>Covid-19 Lockdown and Deviant Sexual Fantasies</brief_title>
  <official_title>Descriptive Study on the Impact of Covid-19 Lockdown on Deviant Sexual Fantasies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our society is going through an unprecedented situation: the COVID 19 Pandemic is forcing&#xD;
      many populations, worldwide, into confinement for their own protection. The very&#xD;
      characteristics of this confinement and of the disease (isolation, potential severity of the&#xD;
      illness, being psychologically unprepared for such a circumstance) have a significant impact&#xD;
      on one's psyche, like emotional disorders -anxiety/depression-, difficulties when returning&#xD;
      to normal life, vicarious traumas… Confinement is paradoxical in as although well-intended to&#xD;
      protect the individual, it leads to the isolation of the individual. This paradox is&#xD;
      destabilizing one's feelings, because when the investigators feel the need for protection and&#xD;
      reassurance, the investigators are left alone and feel abandoned. The investigators therefore&#xD;
      understand that this confinement framework is in essence a situation that might revive&#xD;
      unresolved deprivation situations from the childhood. How to react in front of this upsurge&#xD;
      in anxiety? Strategies used may include, among others, escape in the imaginary through&#xD;
      numerical tools or others, and /or going to the actual characterized by deviant sexual&#xD;
      behaviours. The investigators know in fact that certain moments, like anxiety, depression,&#xD;
      boredom, psychological unrest are propicious for acting, for violent sexual offenders. The&#xD;
      investigators therefore pay extra attention to our patients in such periods favoring these&#xD;
      kinds of trouble.&#xD;
&#xD;
      This study will enable us to understand if the confinement associated with COVID 19 has&#xD;
      generated anxiety that lead sexual offenders or individuals with paraphilic disorders to&#xD;
      engage into deviant fantasies or, potentially sexual activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The questionnaire is handed only one time to each patient and the questions it contains are&#xD;
      part of those commonly used.&#xD;
&#xD;
      How do the investigators precisely operate: self questionnaire on paper, handed to each&#xD;
      patient followed by the CRIAVS in the waiting room, and returned by the patient to the&#xD;
      therapist, or the department, in a sealed envelope. Digital data collection thereafter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of confinement on deviant fantasies</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Lickert scale from 1 to 10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intensity of deviant fantasies</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Likert scale from 0 to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of deviant fantasies</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Likert scale from 0 to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paraphilic type impacted</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Box to be chacked by the patient: exhibition, voyeurism, pedophilia, sadomasochism, crossdressing, raptophilia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of sexual act</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Number given by the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Access mode for deviant fantasies</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Did you use internet : yes or no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of support during confinement</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>box yes or no Was support different? Did you use remote consultation? How did you like it?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating anxiety/depression level</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>HAD Hospital Anxiety And Depression Scale The HAD scale is an instrument for detecting anxiety and depressive disorders. It has 14 listed items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), two scores are obtained (maximum score for each score = 21). - 7 or less: absence of symptoms&#xD;
- 8 to 10: doubtful symptomatology - 11 and more: certain symptomatology.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Deviant Sexual Fantasies</condition>
  <arm_group>
    <arm_group_label>Patients followed by the CRIAVS</arm_group_label>
    <description>Patients followed by the CRIAVS (resource center for workers working with authors of sexual violence) in CHU Motpellier from June to October 2020</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire for evaluation of confinement on deviant sexual fantasies</intervention_name>
    <description>Questionnaire for evaluation of confinement on deviant sexual fantasies. Population already followed for deviant fantasies</description>
    <arm_group_label>Patients followed by the CRIAVS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients followed by the CRIAVS (resource center for workers working with authors of sexual&#xD;
        violence) in CHU Motpellier from June to October 2020&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adults&#xD;
&#xD;
          -  Consulting at the CRIAVS between June and end October 2020&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  no demance&#xD;
&#xD;
          -  no decompensated psychatric disorder&#xD;
&#xD;
          -  no tutelage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celine BAIS</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>December 28, 2020</last_update_submitted>
  <last_update_submitted_qc>December 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sexuality</keyword>
  <keyword>Confinement</keyword>
  <keyword>sex offender</keyword>
  <keyword>outcome</keyword>
  <keyword>paraphilia</keyword>
  <keyword>cybersexuality</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04448405
org study id: RECHMPL20_0341
nct id: NCT04448405
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our society is going through an unprecedented situation: the COVID 19 Pandemic is forcing
      many populations, worldwide, into confinement for their own protection. The very
      characteristics of this confinement and of the disease (isolation, potential severity of the
      illness, being psychologically unprepared for such a circumstance) have a significant impact
      on one's psyche, like emotional disorders -anxiety/depression-, difficulties when returning
      to normal life, vicarious traumas… Confinement is paradoxical in as although well-intended to
      protect the individual, it leads to the isolation of the individual. This paradox is
      destabilizing one's feelings, because when the investigators feel the need for protection and
      reassurance, the investigators are left alone and feel abandoned. The investigators therefore
      understand that this confinement framework is in essence a situation that might revive
      unresolved deprivation situations from the childhood. How to react in front of this upsurge
      in anxiety? Strategies used may include, among others, escape in the imaginary through
      numerical tools or others, and /or going to the actual characterized by deviant sexual
      behaviours. The investigators know in fact that certain moments, like anxiety, depression,
      boredom, psychological unrest are propicious for acting, for violent sexual offenders. The
      investigators therefore pay extra attention to our patients in such periods favoring these
      kinds of trouble.

      This study will enable us to understand if the confinement associated with COVID 19 has
      generated anxiety that lead sexual offenders or individuals with paraphilic disorders to
      engage into deviant fantasies or, potentially sexual activities.
The questionnaire is handed only one time to each patient and the questions it contains are
      part of those commonly used.

      How do the investigators precisely operate: self questionnaire on paper, handed to each
      patient followed by the CRIAVS in the waiting room, and returned by the patient to the
      therapist, or the department, in a sealed envelope. Digital data collection thereafter.
observational model: Cohort
time perspective: Prospective
measure: Impact of confinement on deviant fantasies
time frame: through study completion, an average of 1 year
description: Lickert scale from 1 to 10
measure: Intensity of deviant fantasies
time frame: through study completion, an average of 1 year
description: Likert scale from 0 to 10
measure: Frequency of deviant fantasies
time frame: through study completion, an average of 1 year
description: Likert scale from 0 to 10
measure: Paraphilic type impacted
time frame: through study completion, an average of 1 year
description: Box to be chacked by the patient: exhibition, voyeurism, pedophilia, sadomasochism, crossdressing, raptophilia
measure: Occurrence of sexual act
time frame: through study completion, an average of 1 year
description: Number given by the patient
measure: Access mode for deviant fantasies
time frame: through study completion, an average of 1 year
description: Did you use internet : yes or no
measure: Use of support during confinement
time frame: through study completion, an average of 1 year
description: box yes or no Was support different? Did you use remote consultation? How did you like it?
measure: Evaluating anxiety/depression level
time frame: through study completion, an average of 1 year
description: HAD Hospital Anxiety And Depression Scale The HAD scale is an instrument for detecting anxiety and depressive disorders. It has 14 listed items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), two scores are obtained (maximum score for each score = 21). - 7 or less: absence of symptoms
- 8 to 10: doubtful symptomatology - 11 and more: certain symptomatology.
arm group label: Patients followed by the CRIAVS
description: Patients followed by the CRIAVS (resource center for workers working with authors of sexual violence) in CHU Motpellier from June to October 2020
intervention type: Behavioral
intervention name: Questionnaire for evaluation of confinement on deviant sexual fantasies
description: Questionnaire for evaluation of confinement on deviant sexual fantasies. Population already followed for deviant fantasies
arm group label: Patients followed by the CRIAVS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Celine BAIS
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: NC