Flying PhobiaNCT01442805
Use of Virtual Reality in the Treatment of Flying Phobia
A study testing Virtual Reality Exposure Therapy and Exposure Therapy through Imagination in people with Flying Phobia, run by Luxembourg Institute of Health at 1 site in Luxembourg.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Flying Phobia
- What is being tested?
- Virtual Reality Exposure Therapy and Exposure Therapy through Imagination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteLuxembourg
- Study dates
- Oct 2008to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of a specific phobia (DSM-IV-TR)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude contrôlée Des Effets de la réalité Virtuelle Sur Les symptômes et Les paramètres Physiologiques de Certaines Phobies spécifiques
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.
Read the 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.
- Conditions
- Flying Phobia
- Being tested
- Virtual Reality Exposure Therapy, Exposure Therapy through Imagination
- Keywords
- Cognitive Behavior Therapy, Virtual Reality Exposure Therapy, Psychophysiological Measures, Driving Phobia, Flying Phobia
- Medical subject headings
- Aerophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exposure TherapyBehavioural
Participants are exposed to the feared situation (flying) through the virtual reality technology
Exposure Therapy through ImaginationBehavioural
Participants are exposed to the feared situation (flying) through exposure technique of imagination.
| Study group | Role | What they receive |
|---|---|---|
| RV | Experimental | Cognitive Behavioral Therapy with Virtual Reality Exposures Receives: Behavioral: Virtual Reality Exposure Therapy |
| IMAGO | Experimental | Cognitive Behavioral Therapy with Exposure Therapy through Imagination Receives: Behavioral: Exposure Therapy through Imagination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flight taken
Participants are expected to take a real flight
Measured: 6 months
Secondary outcomes (2)
Physiological Measures
Heart Rate, Breathing frequency, Skin conductance, Skin Temperature, Heart Rate Variability
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startOct 2008
- Primary completionSep 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flying PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Collaborators
- Centre Hospitalier du Luxembourg
- Responsible party
- Sponsor
- Investigators
- Charles Pull, Prof.Dr., Principal investigator, Centre de Recherche Public de la Santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442805
- Sponsor's protocol ID
- 20080102
- Status last verified
- Mar 2017
- First submitted
- 15 Sep 2011
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude contrôlée Des Effets de la réalité Virtuelle Sur Les symptômes et Les paramètres Physiologiques de Certaines Phobies spécifiques
- ClinicalTrials.gov ID
- NCT01442805
- Acronym / sponsor ID
- 20080102
- Conditions
- Flying Phobia
- Keywords
- Cognitive Behavior Therapy, Virtual Reality Exposure Therapy, Psychophysiological Measures, Driving Phobia, Flying Phobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Collaborators
- Centre Hospitalier du Luxembourg
- Study start
- Oct 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RV | Experimental | Behavioral: Virtual Reality Exposure TherapyCognitive Behavioral Therapy with Virtual Reality Exposures |
| IMAGO | Experimental | Behavioral: Exposure Therapy through ImaginationCognitive Behavioral Therapy with Exposure Therapy through Imagination |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of a specific phobia (DSM-IV-TR)
Key exclusion criteria (7 listed)
- Pregnant women
- Subjects with severe pulmonary / cardiovascular problems; Asthma, epilepsy, vertigo
- Drug abuse
- Subjects under on-stabilized anti-depressant treatment
- Psychotic subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Exposure TherapyParticipants are exposed to the feared situation (flying) through the virtual reality technology | Behavioural | RV |
| Exposure Therapy through ImaginationParticipants are exposed to the feared situation (flying) through exposure technique of imagination. | Behavioural | IMAGO |
Primary outcome
Flight taken
Time frame: 6 months
Participants are expected to take a real flight
2 secondary outcomes
Physiological Measures
Time frame: 6 months
Specific Questionnaires
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Pull, Prof.Dr. principal investigator
Centre de Recherche Public de la Santé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Exposure Therapy and Exposure Therapy through Imagination in people with Flying Phobia, run by Luxembourg Institute of Health at 1 site in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flight taken (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.