<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/NCT02990208</url>
  </required_header>
  <id_info>
    <org_study_id>BREATH150521014</org_study_id>
    <nct_id>NCT02990208</nct_id>
  </id_info>
  <brief_title>Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia</brief_title>
  <official_title>Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia: Functional Coping Strategy or Avoidance Behavior? A Pilot Study</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 study investigated the effect of diaphragmatic breathing as an additional coping strategy&#xD;
      during Virtual Reality Exposure Therapy in patients with aviophobia. The authors assumed that&#xD;
      diaphragmatic breathing (DB) would lead to less fear and physiological arousal during the&#xD;
      VRET and to an enhanced treatment outcome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with aviophobia received treatment in Virtual Reality with or without DB. The&#xD;
      authors assumed that adding DB to VRET would enhance treatment effects by reducing fear&#xD;
      during exposure, thus improving the processing of the feared situation. The authors&#xD;
      hypothesized that, as a result, self-efficacy would be increased in comparison to VRET alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 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 FFS (Fear of Flying Scale) scores</measure>
    <time_frame>immediately before the exposure session, immediately after the exposure session, immediately before the test session (which took place one week after the exposure session), immediately after the test session, in a follow up (one year later)</time_frame>
    <description>The Fear of Flying Scale (FFS; German version (Mühlberger &amp; Pauli, 2011)) covers 21 flight situations (e.g., planning the trip, boarding a plane, turbulence during the flight) rated on a 5-point Likert scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in fear ratings</measure>
    <time_frame>both during the VR flights (consisting of four 2-min phases each) of the exposure and the test session. Ratings were asked one minute after the beginning of each phase of each flight.</time_frame>
    <description>Patients were asked to rate their current fear on a scale from 0 (no fear) to 100 (extreme fear)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>during the four 2-min phases of each of the three VR flights of the exposure session and of each of the two VR flights of the test session.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in electrodermal activity (skin conductance level)</measure>
    <time_frame>during the four 2-min phases of each of the three VR flights of the exposure session and of each of the two VR flights of the test session.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy scores</measure>
    <time_frame>immediately before the exposure session, immediately after the exposure session, immediately before the test session (which took place one week after the exposure session), immediately after the test session, in a follow up (one year later)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Fear of Flying</condition>
  <arm_group>
    <arm_group_label>VR exposure + diaphragmatic breathing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual Reality Exposure Therapy + Diaphragmatic breathing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VR exposure</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>Diaphragmatic breathing</intervention_name>
    <description>Patients trained in the technique of diaphragmatic breathing were instructed to take a breath by contracting the diaphragm and were trained to maintain their respiration frequency. They were told to inhale through the nose for four seconds and exhale through the mouth for six seconds (six cycles per minute). Patients then had five minutes to practice by following verbal breathing instructions provided over headphones. During VR exposure breathing instructions were provided via headphones. Diaphragmatic is thought to reduce arousal on the physiological level (Hazlett-Stevens &amp; Craske, 2009) but at the same time not to divert attention from the feared situation to the same extent as other coping strategies</description>
    <arm_group_label>VR exposure + diaphragmatic breathing</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 facilitates the practice of exposure-based treatments especially for situations or places difficult 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 conducted or only in a limited manner (Mühlberger &amp; Pauli, 2011)</description>
    <arm_group_label>VR exposure</arm_group_label>
    <arm_group_label>VR exposure + diaphragmatic breathing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 20 to 65&#xD;
&#xD;
          -  flying experience&#xD;
&#xD;
          -  subjective rating of fear of flying &gt; 60 from 100&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  heart disease&#xD;
&#xD;
          -  current involvement in psychotherapy and/or pharmacotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 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>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Diaphragmatic Breathing</keyword>
  <keyword>Virtual Reality Exposure Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</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/NCT02990208
org study id: BREATH150521014
nct id: NCT02990208
lead sponsor: 
has dmc: No
The study investigated the effect of diaphragmatic breathing as an additional coping strategy
      during Virtual Reality Exposure Therapy in patients with aviophobia. The authors assumed that
      diaphragmatic breathing (DB) would lead to less fear and physiological arousal during the
      VRET and to an enhanced treatment outcome
Patients with aviophobia received treatment in Virtual Reality with or without DB. The
      authors assumed that adding DB to VRET would enhance treatment effects by reducing fear
      during exposure, thus improving the processing of the feared situation. The authors
      hypothesized that, as a result, self-efficacy would be increased in comparison to VRET alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in FFS (Fear of Flying Scale) scores
time frame: immediately before the exposure session, immediately after the exposure session, immediately before the test session (which took place one week after the exposure session), immediately after the test session, in a follow up (one year later)
description: The Fear of Flying Scale (FFS; German version (Mühlberger & Pauli, 2011)) covers 21 flight situations (e.g., planning the trip, boarding a plane, turbulence during the flight) rated on a 5-point Likert scale
measure: Change in fear ratings
time frame: both during the VR flights (consisting of four 2-min phases each) of the exposure and the test session. Ratings were asked one minute after the beginning of each phase of each flight.
description: Patients were asked to rate their current fear on a scale from 0 (no fear) to 100 (extreme fear)
measure: Change in heart rate
time frame: during the four 2-min phases of each of the three VR flights of the exposure session and of each of the two VR flights of the test session.
measure: Change in electrodermal activity (skin conductance level)
time frame: during the four 2-min phases of each of the three VR flights of the exposure session and of each of the two VR flights of the test session.
measure: Change in self-efficacy scores
time frame: immediately before the exposure session, immediately after the exposure session, immediately before the test session (which took place one week after the exposure session), immediately after the test session, in a follow up (one year later)
arm group label: VR exposure + diaphragmatic breathing
arm group type: Experimental
description: Virtual Reality Exposure Therapy + Diaphragmatic breathing
arm group label: VR exposure
arm group type: Active Comparator
description: Virtual Reality Exposure Therapy
intervention type: Behavioral
intervention name: Diaphragmatic breathing
description: Patients trained in the technique of diaphragmatic breathing were instructed to take a breath by contracting the diaphragm and were trained to maintain their respiration frequency. They were told to inhale through the nose for four seconds and exhale through the mouth for six seconds (six cycles per minute). Patients then had five minutes to practice by following verbal breathing instructions provided over headphones. During VR exposure breathing instructions were provided via headphones. Diaphragmatic is thought to reduce arousal on the physiological level (Hazlett-Stevens & Craske, 2009) but at the same time not to divert attention from the feared situation to the same extent as other coping strategies
arm group label: VR exposure + diaphragmatic breathing
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 facilitates the practice of exposure-based treatments especially for situations or places difficult 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 conducted or only in a limited manner (Mühlberger & Pauli, 2011)
arm group label: VR exposure
arm group label: VR exposure + diaphragmatic breathing
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Regensburg
investigator full name: Shiban Youssef
investigator title: Principal Investigator
mesh term: Respiratory Aspiration
sharing ipd: No