Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia
Primary Purpose
Fear of Flying
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diaphragmatic breathing
Virtual Reality Exposure Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Fear of Flying focused on measuring Diaphragmatic Breathing, Virtual Reality Exposure Therapy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VR exposure + diaphragmatic breathing
VR exposure
Arm Description
Virtual Reality Exposure Therapy + Diaphragmatic breathing
Virtual Reality Exposure Therapy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in fear ratings
Patients were asked to rate their current fear on a scale from 0 (no fear) to 100 (extreme fear)
Change in heart rate
Change in electrodermal activity (skin conductance level)
Change in self-efficacy scores
Full Information
NCT ID
NCT02990208
First Posted
December 5, 2016
Last Updated
December 7, 2016
Sponsor
University of Regensburg
1. Study Identification
Unique Protocol Identification Number
NCT02990208
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fear of Flying
Keywords
Diaphragmatic Breathing, Virtual Reality Exposure Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VR exposure + diaphragmatic breathing
Arm Type
Experimental
Arm Description
Virtual Reality Exposure Therapy + Diaphragmatic breathing
Arm Title
VR exposure
Arm Type
Active Comparator
Arm Description
Virtual Reality Exposure Therapy
Intervention Type
Behavioral
Intervention Name(s)
Diaphragmatic breathing
Intervention 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
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy
Intervention 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)
Primary Outcome Measure Information:
Title
Change in FFS (Fear of Flying Scale) scores
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
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)
Secondary Outcome Measure Information:
Title
Change in fear ratings
Description
Patients were asked to rate their current fear on a scale from 0 (no fear) to 100 (extreme fear)
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.
Title
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.
Title
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.
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28100203
Citation
Shiban Y, Diemer J, Muller J, Brutting-Schick J, Pauli P, Muhlberger 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.
Results Reference
derived
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Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia
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