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Use of Virtual Reality in the Treatment of Flying Phobia

Primary Purpose

Flying Phobia

Status
Completed
Phase
Not Applicable
Locations
Luxembourg
Study Type
Interventional
Intervention
Virtual Reality Exposure Therapy
Exposure Therapy through Imagination
Sponsored by
Luxembourg Institute of Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flying Phobia focused on measuring Cognitive Behavior Therapy, Virtual Reality Exposure Therapy, Psychophysiological Measures, Driving Phobia, Flying Phobia

Eligibility Criteria

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

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

Sites / Locations

  • Centre de Recherche Public de la Santé

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

RV

IMAGO

Arm Description

Cognitive Behavioral Therapy with Virtual Reality Exposures

Cognitive Behavioral Therapy with Exposure Therapy through Imagination

Outcomes

Primary Outcome Measures

Flight taken
Participants are expected to take a real flight

Secondary Outcome Measures

Physiological Measures
Heart Rate, Breathing frequency, Skin conductance, Skin Temperature, Heart Rate Variability
Specific Questionnaires
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

Full Information

First Posted
September 15, 2011
Last Updated
March 13, 2017
Sponsor
Luxembourg Institute of Health
Collaborators
Centre Hospitalier du Luxembourg
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1. Study Identification

Unique Protocol Identification Number
NCT01442805
Brief Title
Use of Virtual Reality in the Treatment of Flying Phobia
Official Title
Etude contrôlée Des Effets de la réalité Virtuelle Sur Les symptômes et Les paramètres Physiologiques de Certaines Phobies spécifiques
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luxembourg Institute of Health
Collaborators
Centre Hospitalier du Luxembourg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flying Phobia
Keywords
Cognitive Behavior Therapy, Virtual Reality Exposure Therapy, Psychophysiological Measures, Driving Phobia, Flying Phobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RV
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy with Virtual Reality Exposures
Arm Title
IMAGO
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy with Exposure Therapy through Imagination
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy
Intervention Description
Participants are exposed to the feared situation (flying) through the virtual reality technology
Intervention Type
Behavioral
Intervention Name(s)
Exposure Therapy through Imagination
Intervention Description
Participants are exposed to the feared situation (flying) through exposure technique of imagination.
Primary Outcome Measure Information:
Title
Flight taken
Description
Participants are expected to take a real flight
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Physiological Measures
Description
Heart Rate, Breathing frequency, Skin conductance, Skin Temperature, Heart Rate Variability
Time Frame
6 months
Title
Specific Questionnaires
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Pull, Prof.Dr.
Organizational Affiliation
Centre de Recherche Public de la Santé
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche Public de la Santé
City
Strassen
ZIP/Postal Code
L-1445
Country
Luxembourg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Virtual Reality in the Treatment of Flying Phobia

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