Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia

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

Tracking Information

• First Submitted Date: December 5, 2016
• First Posted Date: December 13, 2016
• Last Update Posted Date: December 13, 2016
• Study Start Date: January 2014
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Fear of Flying

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 7, 2016): 30
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2015
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02990208
• Other Study ID Numbers: BREATH150521014
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Shiban Youssef, University of Regensburg
• Study Sponsor: University of Regensburg
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Regensburg
• Verification Date: December 2016