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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
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fear of Flying focused on measuring Diaphragmatic Breathing, Virtual Reality Exposure Therapy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 5, 2016
    Last Updated
    December 7, 2016
    Sponsor
    University of Regensburg
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    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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