<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/NCT02973919</url>
  </required_header>
  <id_info>
    <org_study_id>URegensburg</org_study_id>
    <nct_id>NCT02973919</nct_id>
  </id_info>
  <brief_title>EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome</brief_title>
  <official_title>EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Regensburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Regensburg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to increase the efficiency of exposure in virtual reality (VR).&#xD;
&#xD;
      Based on the EMDR research the investigators would like to show that the implementation of&#xD;
      eye movements during the VR exposure results in a faster physiological relaxation response&#xD;
      among probands with spider phobia, which has a positive effect on the subjective and&#xD;
      behavioral efficacy of the VR exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The VR paradigm consists of one room with a spider in it. The proband is supposed to look at&#xD;
      it for a few minutes. This exposure is repeated several times.&#xD;
&#xD;
      In the experimental group a ball appears during the exposure, that moves horizontally across&#xD;
      the room. The probands are supposed to follow this movement with their eyes.&#xD;
&#xD;
      EDA, EKG and respiration are being recorded. Furthermore the subjective and behavioral spider&#xD;
      phobia is measured before, during and after the exposure to determine occurring changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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 Behavioral Assessment Test (BAT) in vivo</measure>
    <time_frame>5 minutes before, 5 minutes after intervention and during folow up (2 weeks post Intervention)</time_frame>
    <description>expected fear just before getting started and actually present fear just before finishing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin Conductance Reactivity (SCR)</measure>
    <time_frame>during the VR-session</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiogram (ECG)</measure>
    <time_frame>during the VR-session</time_frame>
    <description>providing the Heart Rate (HR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>manipulation check electrode below the right eye (M. orbicularis oculi)</measure>
    <time_frame>during the VR- exposure sessions (5 min x 4 sessions)</time_frame>
    <description>for registering eye movements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Subjective Fear Ratings</measure>
    <time_frame>1 min before and during ( each minute) exposure in Virtual Reality</time_frame>
    <description>Subjective Units of Disturbance Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Spider Phobia</condition>
  <arm_group>
    <arm_group_label>Eye movements</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eye Movement Desensitization and Reprocessing Therapy + virtual reality exposure therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>virtual reality exposure therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Eye Movement Desensitization and Reprocessing Therapy</intervention_name>
    <description>In 1989, Shapiro discovered that while talking about negative life events or thoughts, rhythmic eye movements on a horizontal axis can alleviate the associated vividness and burden (Shapiro, 1989). She established the psychodynamic-behavioral Eye Movement Desensitization and Reprocessing (EMDR) Therapy, which includes the induction of rhythmic eye movements as a central feature. EMDR is regarded as an efficient treatment tool. Several times it has also been successfully applied in the field of specific phobias (de Jongh, ten Broeke, &amp; Renssen, 1999; de Jongh, Holmshaw, Carswell, &amp; van Wijk, 2011; Lapsekili &amp; Yelboga, 2014; Muris, Merckelbach, van Haaften, &amp; Mayer, 1997) and there is a standard protocol for using EMDR on specific fears and phobias (de Jongh, 2015).</description>
    <arm_group_label>Eye movements</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual Reality Exposure Therapy</intervention_name>
    <description>Exposure to fear-evoking stimuli is conducted more often in virtual environments using simulators or similar computer-technologies (Virtual Reality Exposure Therapy, VRET). One great advantage of using VR-technologies is that it is possible to create an environment which is highly controllable by its creators. Feared stimuli or scenarios can be varied on individual purposes and presented several times. This facili- tates the practice of exposure-based treatments especially for situations or places diffi- cult to access or requiring a considerable amount of time and/or money (e.g. being in war zones or a passenger on a flight), where in vivo exposures have often not been con- ducted or only in a limited manner (Mühlberger &amp; Pauli, 2011).</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Eye movements</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the Structured Clinical Interview for DSM-IV (SCID, First et al., 2002; applied German&#xD;
             translation: Strukturiertes Klinisches Interview für DSM-IV, Achse I, SKID I, Wittchen&#xD;
             et al., 1997), in order to get a reliable diagnosis of spider phobia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  current psychopharmacological medication&#xD;
&#xD;
          -  current involvement in psychiatric- or psychotherapeutic treatment&#xD;
&#xD;
          -  cardiovascular or neurological diseases&#xD;
&#xD;
          -  color blindness&#xD;
&#xD;
          -  hearing disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Regensburg</investigator_affiliation>
    <investigator_full_name>Shiban Youssef</investigator_full_name>
    <investigator_title>Phd</investigator_title>
  </responsible_party>
  <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/NCT02973919
org study id: URegensburg
nct id: NCT02973919
lead sponsor: 
has dmc: No
The goal of this study is to increase the efficiency of exposure in virtual reality (VR).

      Based on the EMDR research the investigators would like to show that the implementation of
      eye movements during the VR exposure results in a faster physiological relaxation response
      among probands with spider phobia, which has a positive effect on the subjective and
      behavioral efficacy of the VR exposure.
The VR paradigm consists of one room with a spider in it. The proband is supposed to look at
      it for a few minutes. This exposure is repeated several times.

      In the experimental group a ball appears during the exposure, that moves horizontally across
      the room. The probands are supposed to follow this movement with their eyes.

      EDA, EKG and respiration are being recorded. Furthermore the subjective and behavioral spider
      phobia is measured before, during and after the exposure to determine occurring changes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Behavioral Assessment Test (BAT) in vivo
time frame: 5 minutes before, 5 minutes after intervention and during folow up (2 weeks post Intervention)
description: expected fear just before getting started and actually present fear just before finishing
measure: Skin Conductance Reactivity (SCR)
time frame: during the VR-session
measure: Electrocardiogram (ECG)
time frame: during the VR-session
description: providing the Heart Rate (HR)
measure: manipulation check electrode below the right eye (M. orbicularis oculi)
time frame: during the VR- exposure sessions (5 min x 4 sessions)
description: for registering eye movements
measure: Change in Subjective Fear Ratings
time frame: 1 min before and during ( each minute) exposure in Virtual Reality
description: Subjective Units of Disturbance Scale
arm group label: Eye movements
arm group type: Experimental
description: Eye Movement Desensitization and Reprocessing Therapy + virtual reality exposure therapy
arm group label: Control
arm group type: Active Comparator
description: virtual reality exposure therapy
intervention type: Behavioral
intervention name: Eye Movement Desensitization and Reprocessing Therapy
description: In 1989, Shapiro discovered that while talking about negative life events or thoughts, rhythmic eye movements on a horizontal axis can alleviate the associated vividness and burden (Shapiro, 1989). She established the psychodynamic-behavioral Eye Movement Desensitization and Reprocessing (EMDR) Therapy, which includes the induction of rhythmic eye movements as a central feature. EMDR is regarded as an efficient treatment tool. Several times it has also been successfully applied in the field of specific phobias (de Jongh, ten Broeke, & Renssen, 1999; de Jongh, Holmshaw, Carswell, & van Wijk, 2011; Lapsekili & Yelboga, 2014; Muris, Merckelbach, van Haaften, & Mayer, 1997) and there is a standard protocol for using EMDR on specific fears and phobias (de Jongh, 2015).
arm group label: Eye movements
intervention type: Behavioral
intervention name: Virtual Reality Exposure Therapy
description: Exposure to fear-evoking stimuli is conducted more often in virtual environments using simulators or similar computer-technologies (Virtual Reality Exposure Therapy, VRET). One great advantage of using VR-technologies is that it is possible to create an environment which is highly controllable by its creators. Feared stimuli or scenarios can be varied on individual purposes and presented several times. This facili- tates the practice of exposure-based treatments especially for situations or places diffi- cult to access or requiring a considerable amount of time and/or money (e.g. being in war zones or a passenger on a flight), where in vivo exposures have often not been con- ducted or only in a limited manner (Mühlberger & Pauli, 2011).
arm group label: Control
arm group label: Eye movements
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Regensburg
investigator full name: Shiban Youssef
investigator title: Phd
mesh term: Phobic Disorders
sharing ipd: No