Overview

This trial is active, not recruiting.

Condition flying phobia
Treatments virtual reality exposure therapy, exposure therapy through imagination
Phase phase 2
Sponsor Centre de Recherche Public de la Sante, Luxembourg
Collaborator Centre Hospitalier du Luxembourg
Start date October 2008
End date September 2011
Trial size 30 participants
Trial identifier NCT01442805, 20080102

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cognitive Behavioral Therapy with Virtual Reality Exposures
virtual reality exposure therapy
Participants are exposed to the feared situation (flying) through the virtual reality technology
(Experimental)
Cognitive Behavioral Therapy with Exposure Therapy through Imagination
exposure therapy through imagination
Participants are exposed to the feared situation (flying) through exposure technique of imagination.

Primary Outcomes

Measure
Flight taken
time frame: 6 months

Secondary Outcomes

Measure
Physiological Measures
time frame: 6 months
Specific Questionnaires
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Etude contrôlée Des Effets de la réalité Virtuelle Sur Les symptômes et Les paramètres Physiologiques de Certaines Phobies spécifiques
Principal investigator Charles Pull, Prof.Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Centre de Recherche Public de la Sante, Luxembourg.