Clinical trial NCT01442805: 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
Overall status: COMPLETED
Phase: NA
Conditions: Flying Phobia
Keywords: Cognitive Behavior Therapy
Virtual Reality Exposure Therapy
Psychophysiological Measures
Driving Phobia
Flying Phobia
Lead sponsor: Luxembourg Institute of Health
Sponsor class: OTHER_GOV
Collaborators: name: Centre Hospitalier du Luxembourg
First posted: 2011-09-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Flight taken
timeFrame: 6 months
Secondary outcomes:
measure: Physiological Measures
timeFrame: 6 months
measure: Specific Questionnaires
timeFrame: 6 months
Other outcomes:
Locations:
city: Strassen
country: Luxembourg
facility: Centre de Recherche Public de la Santé
Study officials:
affiliation: Centre de Recherche Public de la Santé
name: Charles Pull, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: