Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia

Fear of Flying Clinical Trial

Official title:

Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia: Functional Coping Strategy or Avoidance Behavior? A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990208
• Other study ID #: BREATH150521014
• Status: Completed
• Phase: N/A
• First received: December 5, 2016
• Last updated: December 7, 2016
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2016
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fear of Flying
• Respiratory Aspiration

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
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FFS (Fear of Flying Scale) scores	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	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)	No
Secondary	Change in fear ratings	Patients were asked to rate their current fear on a scale from 0 (no fear) to 100 (extreme fear)	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.	No
Secondary	Change in heart rate		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.	No
Secondary	Change in electrodermal activity (skin conductance level)		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.	No
Secondary	Change in self-efficacy scores		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)	No