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Clinical Trials/NCT01442805
NCT01442805CompletedNot Applicable

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

Luxembourg Institute of Health1 site in 1 country36 target enrollmentStarted: October 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
Flight taken

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

RV

Experimental

Cognitive Behavioral Therapy with Virtual Reality Exposures

Intervention: Virtual Reality Exposure Therapy (Behavioral)

IMAGO

Experimental

Cognitive Behavioral Therapy with Exposure Therapy through Imagination

Intervention: Exposure Therapy through Imagination (Behavioral)

Outcomes

Primary Outcomes

Flight taken

Time Frame: 6 months

Participants are expected to take a real flight

Secondary Outcomes

  • Physiological Measures(6 months)
  • Specific Questionnaires(6 months)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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