<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/NCT03031002</url>
  </required_header>
  <id_info>
    <org_study_id>ZL 59/2-2</org_study_id>
    <nct_id>NCT03031002</nct_id>
  </id_info>
  <brief_title>Extinction Generalization in Exposure Therapy</brief_title>
  <official_title>Extinction Generalization in Exposure Therapy for Spider Phobia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruhr University of Bochum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruhr University of Bochum</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with anxiety disorders oftentimes express fear responses to more than only one&#xD;
      fear-inducing object. The principal aim of this study is to examine whether the beneficial&#xD;
      effects of exposure on fear reduction in spider phobia can extend to stimuli which are&#xD;
      conceptually similar to spiders (i.e. cockroaches), but have never been presented during the&#xD;
      respective treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fear extinction has evolved as the central mechanism underlying exposure-based treatments.&#xD;
      Findings from conditioning studies indicate that fear reduction following a fear extinction&#xD;
      procedure can generalize from the extinction stimulus to other conceptually and perceptually&#xD;
      related stimuli. This study is aimed at translating these findings to a clinical application&#xD;
      and will hence examine whether the basic principles of extinction generalization are&#xD;
      applicable to exposure.&#xD;
&#xD;
      Patients with spider phobia will either receive two sessions of in-vivo exposure with spiders&#xD;
      or no treatment. Prior to as well as after treatment, patient's fear of spiders will be&#xD;
      assessed using the Behavioral Approach Test (BATs) and self-report questionnaires. In&#xD;
      addition, BATs with cockroaches will be conducted to examine the effects of exposure therapy&#xD;
      on extinction generalization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Behavioral Approach Test (BAT) from pre- to posttreatment</measure>
    <time_frame>Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)</time_frame>
    <description>Behavioral Approach Tests with Spiders and Cockroaches will be conducted at pre- and posttreatment. Here, the closest proximity a participant is able to attain to the spider/cockroach will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Subjective Fear / Disgust during the Behavioral Approach Tests (BATs) using the Subjective Units of Distress Scale (SUDS)</measure>
    <time_frame>Pre-and Posttreatment (with approximately 4 days between pre- and posttreatment)</time_frame>
    <description>Subjective Fear / Disgust during the Behavioral Approach will be assessed at the initial and final approach distances to the spider / cockroach during the respective BATs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Heart Rate during the Behavioral Approach Tests (BATs) from pre- to posttreatment</measure>
    <time_frame>Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)</time_frame>
    <description>During each BAT with spiders and cockroaches, heart rate will be measured. In addition, a 5-minute baseline will be recorded prior to the first BAT at each assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Fear of Spiders Questionnaire (FSQ)</measure>
    <time_frame>Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Spider Phobia Questionnaire (SPQ)</measure>
    <time_frame>Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Spider Beliefs Questionnaire (SBQ)</measure>
    <time_frame>Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Epigenetic / DNA methylation</measure>
    <time_frame>Pre- and posttreatment (with approximately 4 days between pre- and posttreatment)</time_frame>
    <description>DNA collection kits at pre- and posttreatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Depression Anxiety Stress Scales (DASS)</measure>
    <time_frame>Pretreatment (assessed once prior to treatment)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Questionnaire for the Assessment of Disgust Sensitivity (FEE)</measure>
    <time_frame>Pretreatment (assessed once prior to treatment)</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Specific Phobia</condition>
  <arm_group>
    <arm_group_label>Exposure Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants of this arm receive two 60-minute sessions of exposure treatment for spider fear</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Exposure Treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants of this arm receive no exposure or other adequate treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure treatment for spider fear</intervention_name>
    <description>Two sessions (each session = 60 minutes) of in-vivo exposure treatment (including psychoeducation) with two different spiders. Exposures comprise a hierarchy of 7 steps, to be completed with both spiders.</description>
    <arm_group_label>Exposure Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  spider phobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)&#xD;
             -IV criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any neurological or neuropsychiatric condition&#xD;
&#xD;
          -  current behavioral or pharmacological treatment&#xD;
&#xD;
          -  any mental disorder that is considered more severe than specific phobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Armin Zlomuzica, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruhr University of Bochum</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruhr University of Bochum</investigator_affiliation>
    <investigator_full_name>Armin Zlomuzica</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>exposure</keyword>
  <keyword>spider phobia</keyword>
  <keyword>generalization</keyword>
  <keyword>extinction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phobic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03031002
org study id: ZL 59/2-2
nct id: NCT03031002
lead sponsor: 
has dmc: No
Patients with anxiety disorders oftentimes express fear responses to more than only one
      fear-inducing object. The principal aim of this study is to examine whether the beneficial
      effects of exposure on fear reduction in spider phobia can extend to stimuli which are
      conceptually similar to spiders (i.e. cockroaches), but have never been presented during the
      respective treatment.
Fear extinction has evolved as the central mechanism underlying exposure-based treatments.
      Findings from conditioning studies indicate that fear reduction following a fear extinction
      procedure can generalize from the extinction stimulus to other conceptually and perceptually
      related stimuli. This study is aimed at translating these findings to a clinical application
      and will hence examine whether the basic principles of extinction generalization are
      applicable to exposure.

      Patients with spider phobia will either receive two sessions of in-vivo exposure with spiders
      or no treatment. Prior to as well as after treatment, patient's fear of spiders will be
      assessed using the Behavioral Approach Test (BATs) and self-report questionnaires. In
      addition, BATs with cockroaches will be conducted to examine the effects of exposure therapy
      on extinction generalization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the Behavioral Approach Test (BAT) from pre- to posttreatment
time frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
description: Behavioral Approach Tests with Spiders and Cockroaches will be conducted at pre- and posttreatment. Here, the closest proximity a participant is able to attain to the spider/cockroach will be measured.
measure: Change in Subjective Fear / Disgust during the Behavioral Approach Tests (BATs) using the Subjective Units of Distress Scale (SUDS)
time frame: Pre-and Posttreatment (with approximately 4 days between pre- and posttreatment)
description: Subjective Fear / Disgust during the Behavioral Approach will be assessed at the initial and final approach distances to the spider / cockroach during the respective BATs.
measure: Change in Heart Rate during the Behavioral Approach Tests (BATs) from pre- to posttreatment
time frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
description: During each BAT with spiders and cockroaches, heart rate will be measured. In addition, a 5-minute baseline will be recorded prior to the first BAT at each assessment.
measure: Change in the Fear of Spiders Questionnaire (FSQ)
time frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
measure: Change in the Spider Phobia Questionnaire (SPQ)
time frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
measure: Change in the Spider Beliefs Questionnaire (SBQ)
time frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
measure: Epigenetic / DNA methylation
time frame: Pre- and posttreatment (with approximately 4 days between pre- and posttreatment)
description: DNA collection kits at pre- and posttreatment
measure: Depression Anxiety Stress Scales (DASS)
time frame: Pretreatment (assessed once prior to treatment)
measure: Questionnaire for the Assessment of Disgust Sensitivity (FEE)
time frame: Pretreatment (assessed once prior to treatment)
arm group label: Exposure Treatment
arm group type: Experimental
description: Participants of this arm receive two 60-minute sessions of exposure treatment for spider fear
arm group label: No Exposure Treatment
arm group type: No Intervention
description: Participants of this arm receive no exposure or other adequate treatment
intervention type: Behavioral
intervention name: Exposure treatment for spider fear
description: Two sessions (each session = 60 minutes) of in-vivo exposure treatment (including psychoeducation) with two different spiders. Exposures comprise a hierarchy of 7 steps, to be completed with both spiders.
arm group label: Exposure Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Armin Zlomuzica, Dr.
role: Principal Investigator
affiliation: Ruhr University of Bochum
responsible party type: Principal Investigator
investigator affiliation: Ruhr University of Bochum
investigator full name: Armin Zlomuzica
investigator title: Dr.
mesh term: Phobic Disorders
sharing ipd: No