- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01442805
Use of Virtual Reality in the Treatment of Flying Phobia
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Strassen, Luxembourg, L-1445
- Centre de Recherche Public de la Santé
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Participants are exposed to the feared situation (flying) through the virtual reality technology
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Experimental: IMAGO
Cognitive Behavioral Therapy with Exposure Therapy through Imagination
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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
Sponsor
Collaborators
Investigators
- Principal Investigator: Charles Pull, Prof.Dr., Centre de Recherche Public de la Santé
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20080102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Flying Phobia
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Universitat Jaume ICompleted
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Emory UniversityNational Institute of Mental Health (NIMH)Completed
-
Idan Moshe AderkaCompleted
-
Shanghai Mental Health CenterRecruitingA Preliminary Study on the Intervention Effect of Virtual Reality Exposure Therapy on Fear of FlyingFear of Flying | Virtual Reality Exposure TherapyChina
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Umeå UniversityUppsala UniversityCompleted
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Umeå UniversityCompleted
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Stanford UniversityNational Institute of Mental Health (NIMH)CompletedSocial PhobiaUnited States
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University of MinnesotaAstraZenecaCompletedSocial PhobiaUnited States
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Modum BadCompleted
Clinical Trials on Virtual Reality Exposure Therapy
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VU University of AmsterdamCompletedSocial Anxiety Disorder | Social PhobiaNetherlands
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Tomorrow Sp. z o.o.National Center for Research and Development, PolandCompleted
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Georgia State UniversityVirtually Better, Inc.CompletedSocial Anxiety DisorderUnited States
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Weill Medical College of Cornell UniversityCornell UniversityRecruitingPosttraumatic Stress DisorderUnited States
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Stockholm UniversityCompletedAnxiety | Social Phobia | Behavior TherapySweden
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Johns Hopkins UniversityCompletedSpecific Phobia | Specific Phobia, Animal | Specific Phobia, Situational | Specific Phobia, Natural Environment | Childhood Anxiety DisorderUnited States
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University of Notre DameCompletedSpecific Phobia | Anxiety Disorder | Fear of Heights | AcrophobiaUnited States
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Idan Moshe AderkaCompleted
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Shanghai Mental Health CenterCompletedTranscranial Direct Current Stimulation | AcrophobiaChina