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Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia

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ClinicalTrials.gov Identifier: NCT02990208
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Shiban Youssef, University of Regensburg

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Fear of Flying Behavioral: Diaphragmatic breathing Behavioral: Virtual Reality Exposure Therapy Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia: Functional Coping Strategy or Avoidance Behavior? A Pilot Study
Study Start Date : January 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: VR exposure + diaphragmatic breathing
Virtual Reality Exposure Therapy + Diaphragmatic breathing
Behavioral: Diaphragmatic breathing
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

Behavioral: Virtual Reality Exposure Therapy
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)

Active Comparator: VR exposure
Virtual Reality Exposure Therapy
Behavioral: Virtual Reality Exposure Therapy
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)




Primary Outcome Measures :
  1. 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) ]
    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


Secondary Outcome Measures :
  1. 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. ]
    Patients were asked to rate their current fear on a scale from 0 (no fear) to 100 (extreme fear)

  2. 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. ]
  3. 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. ]
  4. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 20 to 65
  • flying experience
  • subjective rating of fear of flying > 60 from 100

Exclusion Criteria:

  • pregnancy
  • heart disease
  • current involvement in psychotherapy and/or pharmacotherapy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shiban Youssef, Principal Investigator, University of Regensburg
ClinicalTrials.gov Identifier: NCT02990208    
Other Study ID Numbers: BREATH150521014
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shiban Youssef, University of Regensburg:
Diaphragmatic Breathing
Virtual Reality Exposure Therapy
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes