Use of Virtual Reality in the Treatment of Flying Phobia

Flying Phobia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442805
• Other study ID #: 20080102
• Status: Completed
• Phase: N/A
• First received: September 15, 2011
• Last updated: March 13, 2017
• Start date: October 2008
• Est. completion date: March 2012

Study information

• Verified date: March 2017
• Source: Luxembourg Institute of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Flying Phobia
• Phobic Disorders

Intervention

Behavioral:
• Virtual Reality Exposure Therapy
Participants are exposed to the feared situation (flying) through the virtual reality technology
• Exposure Therapy through Imagination
Participants are exposed to the feared situation (flying) through exposure technique of imagination.

Locations

Country	Name	City	State
Luxembourg	Centre de Recherche Public de la Santé	Strassen

Sponsors (2)

Lead Sponsor	Collaborator
Luxembourg Institute of Health	Centre Hospitalier du Luxembourg

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flight taken	Participants are expected to take a real flight	6 months
Secondary	Physiological Measures	Heart Rate, Breathing frequency, Skin conductance, Skin Temperature, Heart Rate Variability	6 months
Secondary	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	6 months

External Links

•   CRP-Santé / LATE