NCT02990208

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

December 5, 2016

Last Update Submit

December 7, 2016

Conditions

Keywords

Diaphragmatic BreathingVirtual Reality Exposure Therapy

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (4)

  • Change in fear ratings

    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.

  • 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.

  • 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.

  • 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)

Study Arms (2)

VR exposure + diaphragmatic breathing

EXPERIMENTAL

Virtual Reality Exposure Therapy + Diaphragmatic breathing

Behavioral: Diaphragmatic breathingBehavioral: Virtual Reality Exposure Therapy

VR exposure

ACTIVE COMPARATOR

Virtual Reality Exposure Therapy

Behavioral: Virtual Reality Exposure Therapy

Interventions

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

VR exposure + diaphragmatic breathing

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)

VR exposureVR exposure + diaphragmatic breathing

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 20 to 65
  • flying experience
  • subjective rating of fear of flying \> 60 from 100

You may not qualify if:

  • pregnancy
  • heart disease
  • current involvement in psychotherapy and/or pharmacotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Aerophobia

Interventions

Virtual Reality Exposure Therapy

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2016

First Posted

December 13, 2016

Study Start

January 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 13, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share