Use of Virtual Reality in the Treatment of Flying Phobia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Centre de Recherche Public de la Sante, Luxembourg.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Centre Hospitalier du Luxembourg
Information provided by (Responsible Party):
Marc Damme, Centre de Recherche Public de la Sante, Luxembourg
ClinicalTrials.gov Identifier:
NCT01442805
First received: September 15, 2011
Last updated: September 28, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Flying Phobia
Behavioral: Virtual Reality Exposure Therapy
Behavioral: Exposure Therapy through Imagination
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Etude contrôlée Des Effets de la réalité Virtuelle Sur Les symptômes et Les paramètres Physiologiques de Certaines Phobies spécifiques

Resource links provided by NLM:


Further study details as provided by Centre de Recherche Public de la Sante, Luxembourg:

Primary Outcome Measures:
  • Flight taken [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Participants are expected to take a real flight


Secondary Outcome Measures:
  • Physiological Measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Heart Rate, Breathing frequency, Skin conductance, Skin Temperature, Heart Rate Variability

  • Specific Questionnaires [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RV
Cognitive Behavioral Therapy with Virtual Reality Exposures
Behavioral: Virtual Reality Exposure Therapy
Participants are exposed to the feared situation (flying) through the virtual reality technology
Experimental: IMAGO
Cognitive Behavioral Therapy with Exposure Therapy through Imagination
Behavioral: Exposure Therapy through Imagination
Participants are exposed to the feared situation (flying) through exposure technique of 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442805

Locations
Luxembourg
Centre de Recherche Public de la Santé
Strassen, Luxembourg, L-1445
Sponsors and Collaborators
Centre de Recherche Public de la Sante, Luxembourg
Centre Hospitalier du Luxembourg
Investigators
Principal Investigator: Charles Pull, Prof.Dr. Centre de Recherche Public de la Santé
  More Information

No publications provided

Responsible Party: Marc Damme, Principal Investigator, Centre de Recherche Public de la Sante, Luxembourg
ClinicalTrials.gov Identifier: NCT01442805     History of Changes
Other Study ID Numbers: 20080102
Study First Received: September 15, 2011
Last Updated: September 28, 2011
Health Authority: Luxembourg: Comite National d'Ethique de Recherche

Keywords provided by Centre de Recherche Public de la Sante, Luxembourg:
Cognitive Behavior Therapy
Virtual Reality Exposure Therapy
Psychophysiological Measures
Driving Phobia
Flying Phobia

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014