Use of Virtual Reality in the Treatment of Flying Phobia

March 13, 2017 updated by: Luxembourg Institute of Health

Etude contrôlée Des Effets de la réalité Virtuelle Sur Les symptômes et Les paramètres Physiologiques de Certaines Phobies spécifiques

The project aims to explore the potential of Virtual Reality Exposure Therapy (VRET) for the treatment of the fear of driving, the fear of flying and the fear of public speaking.

The study is a randomized controlled trial (RCT) designed to compare the efficiency of cognitive behavioural therapy with exposures in imagination to behavioural therapy with exposures in virtual reality. Anxiety levels are measured using specific questionnaires, SUD ratings and physiological measures (heart rate, skin conductance, skin temperature, breathing frequency, heart rate variability).

Hypothesis: Treatments with exposures in virtual reality are more efficient than treatments with exposures in imagination.

Study Overview

Detailed Description

In the past, several studies have demonstrated the effectiveness of virtual reality exposure therapy in the treatment of flying phobia and driving phobia. As an objective tool, psychophysiological recordings help demonstrate the decrease of physiological aspects of anxiety reactions (heart rate, skin conductance, skin temperature, heart rate variability and breathing pattern).

The aim of the present study is to examine the effects of cognitive behavioural therapy with exposures in imagination to behavioural therapy with exposures in virtual reality in the treatment of patients with flying phobia. Thirty patients will be randomized into either an imagination exposure group or a virtual reality exposure group after having received four sessions of cognitive behavioural therapy for coping with panic attacks. Respective exposure therapies consist in four sessions.

Anxiety levels will be measured before and after the cognitive behavioural therapy for coping with panic attacks as well as before and after the exposure therapy sessions and after 3 months using specific questionnaires, SUD ratings and psychophysiological measures (heart rate, skin conductance, skin temperature, breathing frequency and heart rate variability). The exposure stimuli will consist in a 10min movie of a flight with an insight-cabin viewing perspective.

The investigators hypothesize that virtual reality exposure therapies will be more effective than imagination exposure therapy in terms of decrease of anxiety self-ratings and psychophysiological fear reactions.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Strassen, Luxembourg, L-1445
        • Centre de Recherche Public de la Santé

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of a specific phobia (DSM-IV-TR)

Exclusion Criteria:

  • Pregnant women
  • Subjects with severe pulmonary / cardiovascular problems; Asthma, epilepsy, vertigo
  • Drug abuse
  • Subjects under on-stabilized anti-depressant treatment
  • Psychotic subjects
  • Subjects with suicidal ideas
  • Subjects presenting insufficient intellectual capabilities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RV
Cognitive Behavioral Therapy with Virtual Reality Exposures
Participants are exposed to the feared situation (flying) through the virtual reality technology
Experimental: IMAGO
Cognitive Behavioral Therapy with Exposure Therapy through Imagination
Participants are exposed to the feared situation (flying) through exposure technique of imagination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flight taken
Time Frame: 6 months
Participants are expected to take a real flight
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological Measures
Time Frame: 6 months
Heart Rate, Breathing frequency, Skin conductance, Skin Temperature, Heart Rate Variability
6 months
Specific Questionnaires
Time Frame: 6 months
Specific Questionnaires: SUD, Motivational Scale, Fear Questionnaire Marks 1979, Sheehan Disability Scale, STAI I & II, BDI, BAI, GAF, Flight Anxiety Situations Questionnaire FAS, Flight Anxiety Modality Questionnaire FAM
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charles Pull, Prof.Dr., Centre de Recherche Public de la Santé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 15, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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