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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

Tracking Information
First Submitted Date  ICMJE December 5, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • 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)
  • 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. ]
  • 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. ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia
Official Title  ICMJE Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia: Functional Coping Strategy or Avoidance Behavior? A Pilot Study
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fear of Flying
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: VR exposure + diaphragmatic breathing
    Virtual Reality Exposure Therapy + Diaphragmatic breathing
    Interventions:
    • Behavioral: Diaphragmatic breathing
    • Behavioral: Virtual Reality Exposure Therapy
  • Active Comparator: VR exposure
    Virtual Reality Exposure Therapy
    Intervention: Behavioral: Virtual Reality Exposure Therapy
Publications * Shiban Y, Diemer J, Müller J, Brütting-Schick J, Pauli P, Mühlberger A. Diaphragmatic breathing during virtual reality exposure therapy for aviophobia: functional coping strategy or avoidance behavior? a pilot study. BMC Psychiatry. 2017 Jan 18;17(1):29. doi: 10.1186/s12888-016-1181-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2016)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02990208
Other Study ID Numbers  ICMJE BREATH150521014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shiban Youssef, University of Regensburg
Study Sponsor  ICMJE University of Regensburg
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Regensburg
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP