AerophobiaNCT05939986
A Protocol for a Virtual Reality Exposure Therapy for Fear of Flying.
A study testing Virtual reality-based exposure treatment with multimodal feedback (VRET-M), Virtual reality-based exposure treatment with bimodal feedback (VRET-B) and Imagery exposure treatment (IET) in people with Aerophobia and Virtual Reality Exposure Therapy, run by University of Barcelona at 1 site in Spain.
Trial summary
This study aims to assess whether adding vibrotactile stimulation to visual and auditory stimulation increases the efficacy of VRET for FoF treatment. Eighty-four participants (18-65 years old) will be assigned to one of three intervention arms, namely the VRET with multimodal feedback (visual, auditory, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aerophobia, Virtual Reality Exposure Therapy, Randomized Controlled Trial
- What is being tested?
- Virtual reality-based exposure treatment with multimodal feedback (VRET-M), Virtual reality-based exposure treatment with bimodal feedback (VRET-B) and Imagery exposure treatment (IET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 31 Jan 2024
- 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
- Subjects who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5, American Psychiatric Association, APA, 2013) criteria for FoF.
Who cannot join
- Individuals with a diagnosis of panic disorder, obsessive-compulsive disorder, or psychotic disorder who have received psychotherapy for their FoF, have been taking prescribed medication for their FoF, or have experienced cardiorespiratory disease or an epilepsy attack will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Psychology. Universitat de Barcelona
Barcelona, 08035
José María MR Ribé Viñes, MD, 676022376 ext. +34, jmribev@gmail.com
Marta MS Ferrer Garcia, PhD, 933125114 ext. +34, martaferrerg@ub.edu
About this study
Official title: Virtual Reality Exposure Therapy for Fear of Flying: Protocol for a Randomized Controlled Trial
This study aims to assess whether adding vibrotactile stimulation to visual and auditory stimulation increases the efficacy of VRET for FoF treatment. Eighty-four participants (18-65 years old) will be assigned to one of three intervention arms, namely the VRET with multimodal feedback (visual, auditory, and vibrotactile; VRET-M), the VRET with bimodal feedback (visual and auditory; VRET-B), or the imagery exposure treatment (IET) without sensory feedback. FoF-related symptoms (primary outcomes) will be measured administering the Fear of Flying Questionnaire-II (QPV-II), the Fear of Flying Scale (FFS), and the Visual Analogic Scale (VAS-A) before and after eight sessions of treatment, and at six- and 12-month follow-ups. Anxiety and the sense of presence experienced during exposure sessions (secondary outcome measures: VAS-A and VAS-P) will also be assessed. It is expected that participants in the VRET-M group will report a further reduction of FoF-related symptomatology after the treatment and at follow-ups compared to participants in the VRET-B and IET groups. Likewise, participants in the VRET-M group are expected to show higher sense of presence levels during exposure sessions in comparison to participants in the VRET-B and IET groups. It is expected that the IET group will report the lowest level of sense of presence and the poorest outcome after treatment and at follow-ups.
Read the detailed description
Participants who meet the inclusion criteria will be invited to participate in the initial treatment session. They will be also required to purchase a flight ticket during the six months after the end of the treatment. Participants will be treated weekly for eight individual sessions. While the first two sessions involve preparation and training, exposure will be conducted between the third and eighth session. The exposure sessions' structure and content will be the same in all conditions. Nevertheless, the VRET-M group will experience vibrotactile cues, while the VRET-B group will not. Furthermore, the IET group will experience its own subjective imagined environment without any external stimulation.
- Being tested
- Virtual reality-based exposure treatment with multimodal feedback (VRET-M), Virtual reality-based exposure treatment with bimodal feedback (VRET-B), Imagery exposure treatment (IET)
- Keywords
- Virtual Reality, Fear of Flying, Exposure, Vibrotactile Cues, Anxiety, Presence
- Medical subject headings
- Aerophobia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality-based exposure treatment with multimodal feedback (VRET-M)Behavioural
The VRET-M group will experience visual, auditive and vibrotactile cues in the exposure sessions.
Virtual reality-based exposure treatment with bimodal feedback (VRET-B)Behavioural
The VRET-B group will experience visual and auditive cues in the exposure sessions.
Imagery exposure treatment (IET)Behavioural
The IET group will experience its own subjective imagined environment without any external stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Virtual Reality Exposure Treatment (VRET-M) | Experimental | VRET with multimodal feedback including visual, auditory and vibrotactile cues. Receives: Behavioral: Virtual reality-based exposure treatment with bimodal feedback (VRET-B); Behavioral: Imagery exposure treatment (IET) |
| Bimodal Virtual Reality Exposure Treatment (VRET-B) | Active comparator | VRET with bimodal feedback including visual and auditory cues. Receives: Behavioral: Virtual reality-based exposure treatment with multimodal feedback (VRET-M); Behavioral: Imagery exposure treatment (IET) |
| Imagery Exposure Treatment (IET) | Active comparator | Imagery exposure treatment without sensory cues. Receives: Behavioral: Virtual reality-based exposure treatment with multimodal feedback (VRET-M); Behavioral: Virtual reality-based exposure treatment with bimodal feedback (VRET-B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS).
To what extend I feel fear about flying by plane? The QPV-II is rated from on a 10-point scale (0 = absence of anxiety, 10 = extreme anxiety) with scores ranging from 0 to 300. The FFS is rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84.
Measured: Before the exposure treatment.
Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS).
To what extend I feel fear about flying by plane? The QPV-II is rated from on a 10-point scale (0 = absence of anxiety, 10 = extreme anxiety) with scores ranging from 0 to 300. The FFS is rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84.
Measured: After eight sessions of treatment during eight weeks.
Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS).
To what extend I feel fear about flying by plane? The QPV-II is rated from on a 10-point scale (0 = absence of anxiety, 10 = extreme anxiety) with scores ranging from 0 to 300. The FFS is rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84.
Measured: At 6 months follow-up after treatment termination.
Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS).
To what extend I feel fear about flying by plane? The QPV-II is rated from on a 10-point scale (0 = absence of anxiety, 10 = extreme anxiety) with scores ranging from 0 to 300. The FFS is rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84.
Measured: At 12 months follow-up after treatment termination.
Anxiety. Administering a Visual Analogue Scale (VAS-A).
To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety).
Measured: Before the exposure treatment.
Anxiety. Administering a Visual Analogue Scale (VAS-A).
To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety).
Measured: After eight sessions of treatment during eight weeks.
Anxiety. Administering a Visual Analogue Scale (VAS-A).
To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety).
Measured: At 6 months follow-up after treatment termination.
Anxiety. Administering a Visual Analogue Scale (VAS-A).
To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety).
Measured: At 12 months follow-up after treatment termination.
Secondary outcomes (4)
Anxiety. Administering a Visual Analogue Scale (VAS-A).
To what extend I feel anxious now? measured from 0 (absence of anxiety) to 10 (extreme anxiety).
Measured: Before each exposure session.
Anxiety. Administering a Visual Analogue Scale (VAS-A).
To what extend I feel anxious now? measured from 0 (absence of anxiety) to 10 (extreme anxiety).
Measured: Every 2 minutes during each exposure session of 60 minutes.
Anxiety. Administering a Visual Analogue Scale (VAS-A).
To what extend I feel anxious now? measured from 0 (absence of anxiety) to 10 (extreme anxiety).
Measured: After eight sessions of treatment during eight weeks.
Sense of Presence. Administering the Visual Analogue Scale (VAS-P).
To what extend I feel present now? measured from 0 (absence of sense of presence) to 10 (extreme sense of presence).
Measured: Every 2 minutes during each exposure session of 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion15 Oct 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AerophobiaStudies 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
- Model description
- Participants will be assigned to one of three intervention arms, namely the VRET with multimodal feedback (visual, auditory, and vibrotactile; VRET-M), the VRET with bimodal feedback (visual and auditory; VRET-B), or the imagery exposure treatment (IET).
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José María Ribé Viñes, University of Barcelona
- Investigators
- José MR Gutiérrez Maldonado, PhD, Study director, Senior PhD Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939986
- Sponsor's protocol ID
- 2926863
- Status last verified
- Jul 2023
- First submitted
- 25 May 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Gerwen LJ, Spinhoven P, Van Dyck R. Behavioral and cognitive group treatment for fear of flying: a randomized controlled trial. J Behav Ther Exp Psychiatry. 2006 Dec;37(4):358-71. doi: 10.1016/j.jbtep.2006.05.002. Epub 2006 Jul 7.
PubMed 16828460Rothbaum BO, Hodges L, Anderson PL, Price L, Smith S. Twelve-month follow-up of virtual reality and standard exposure therapies for the fear of flying. J Consult Clin Psychol. 2002 Apr;70(2):428-32. doi: 10.1037//0022-006x.70.2.428.
PubMed 11952201
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Exposure Therapy for Fear of Flying: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05939986
- Acronym / sponsor ID
- 2926863
- Keywords
- Virtual Reality, Fear of Flying, Exposure, Vibrotactile Cues, Anxiety, Presence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 11 Jul 2023 (actual)
- 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.
This study aims to assess whether adding vibrotactile stimulation to visual and auditory stimulation increases the efficacy of VRET for FoF treatment. Eighty-four participants (18-65 years old) will be assigned to one of three intervention arms, namely the VRET with multimodal feedback (visual, auditory, and vibrotactile; VRET-M), the VRET with bimodal feedback (visual and auditory; VRET-B), or the imagery exposure treatment (IET) without sensory feedback. FoF-related symptoms (primary outcomes) will be measured administering the Fear of Flying Questionnaire-II (QPV-II), the Fear of Flying Scale (FFS), and the Visual Analogic Scale (VAS-A) before and after eight sessions of treatment, and at six- and 12-month follow-ups. Anxiety and the sense of presence experienced during exposure sessions (secondary outcome measures: VAS-A and VAS-P) will also be assessed. It is expected that participants in the VRET-M group will report a further reduction of FoF-related symptomatology after the treatment and at follow-ups compared to participants in the VRET-B and IET groups. Likewise, participants in the VRET-M group are expected to show higher sense of presence levels during exposure sessions in comparison to participants in the VRET-B and IET groups. It is expected that the IET group will report the lowest level of sense of presence and the poorest outcome after treatment and at follow-ups.
Detailed description
Participants who meet the inclusion criteria will be invited to participate in the initial treatment session. They will be also required to purchase a flight ticket during the six months after the end of the treatment. Participants will be treated weekly for eight individual sessions. While the first two sessions involve preparation and training, exposure will be conducted between the third and eighth session. The exposure sessions' structure and content will be the same in all conditions. Nevertheless, the VRET-M group will experience vibrotactile cues, while the VRET-B group will not. Furthermore, the IET group will experience its own subjective imagined environment without any external stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be assigned to one of three intervention arms, namely the VRET with multimodal feedback (visual, auditory, and vibrotactile; VRET-M), the VRET with bimodal feedback (visual and auditory; VRET-B), or the imagery exposure treatment (IET).
| Arm | Type | Receives |
|---|---|---|
| Multimodal Virtual Reality Exposure Treatment (VRET-M) | Experimental | Behavioral: Virtual reality-based exposure treatment with bimodal feedback (VRET-B), Behavioral: Imagery exposure treatment (IET)VRET with multimodal feedback including visual, auditory and vibrotactile cues. |
| Bimodal Virtual Reality Exposure Treatment (VRET-B) | Active comparator | Behavioral: Virtual reality-based exposure treatment with multimodal feedback (VRET-M), Behavioral: Imagery exposure treatment (IET)VRET with bimodal feedback including visual and auditory cues. |
| Imagery Exposure Treatment (IET) | Active comparator | Behavioral: Virtual reality-based exposure treatment with multimodal feedback (VRET-M), Behavioral: Virtual reality-based exposure treatment with bimodal feedback (VRET-B)Imagery exposure treatment without sensory cues. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5, American Psychiatric Association, APA, 2013) criteria for FoF.
Key exclusion criteria (1 listed)
- Individuals with a diagnosis of panic disorder, obsessive-compulsive disorder, or psychotic disorder who have received psychotherapy for their FoF, have been taking prescribed medication for their FoF, or have experienced cardiorespiratory disease or an epilepsy attack will be excluded from the study.
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-based exposure treatment with multimodal feedback (VRET-M)The VRET-M group will experience visual, auditive and vibrotactile cues in the exposure sessions. | Behavioural | Bimodal Virtual Reality Exposure Treatment (VRET-B), Imagery Exposure Treatment (IET) |
| Virtual reality-based exposure treatment with bimodal feedback (VRET-B)The VRET-B group will experience visual and auditive cues in the exposure sessions. | Behavioural | Imagery Exposure Treatment (IET), Multimodal Virtual Reality Exposure Treatment (VRET-M) |
| Imagery exposure treatment (IET)The IET group will experience its own subjective imagined environment without any external stimulation. | Behavioural | Bimodal Virtual Reality Exposure Treatment (VRET-B), Multimodal Virtual Reality Exposure Treatment (VRET-M) |
Primary outcome
Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS).
Time frame: Before the exposure treatment.
To what extend I feel fear about flying by plane? The QPV-II is rated from on a 10-point scale (0 = absence of anxiety, 10 = extreme anxiety) with scores ranging from 0 to 300. The FFS is rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84.
Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS).
Time frame: After eight sessions of treatment during eight weeks.
To what extend I feel fear about flying by plane? The QPV-II is rated from on a 10-point scale (0 = absence of anxiety, 10 = extreme anxiety) with scores ranging from 0 to 300. The FFS is rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84.
Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS).
Time frame: At 6 months follow-up after treatment termination.
To what extend I feel fear about flying by plane? The QPV-II is rated from on a 10-point scale (0 = absence of anxiety, 10 = extreme anxiety) with scores ranging from 0 to 300. The FFS is rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84.
Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS).
Time frame: At 12 months follow-up after treatment termination.
To what extend I feel fear about flying by plane? The QPV-II is rated from on a 10-point scale (0 = absence of anxiety, 10 = extreme anxiety) with scores ranging from 0 to 300. The FFS is rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84.
Anxiety. Administering a Visual Analogue Scale (VAS-A).
Time frame: Before the exposure treatment.
To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety).
Anxiety. Administering a Visual Analogue Scale (VAS-A).
Time frame: After eight sessions of treatment during eight weeks.
To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety).
Anxiety. Administering a Visual Analogue Scale (VAS-A).
Time frame: At 6 months follow-up after treatment termination.
To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety).
Anxiety. Administering a Visual Analogue Scale (VAS-A).
Time frame: At 12 months follow-up after treatment termination.
To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety).
4 secondary outcomes
Anxiety. Administering a Visual Analogue Scale (VAS-A).
Time frame: Before each exposure session.
Anxiety. Administering a Visual Analogue Scale (VAS-A).
Time frame: Every 2 minutes during each exposure session of 60 minutes.
Anxiety. Administering a Visual Analogue Scale (VAS-A).
Time frame: After eight sessions of treatment during eight weeks.
Sense of Presence. Administering the Visual Analogue Scale (VAS-P).
Time frame: Every 2 minutes during each exposure session of 60 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Background: PubMed 16828460Van Gerwen LJ, Spinhoven P, Van Dyck R. Behavioral and cognitive group treatment for fear of flying: a randomized controlled trial. J Behav Ther Exp Psychiatry. 2006 Dec;37(4):358-71. doi: 10.1016/j.jbtep.2006.05.002. Epub 2006 Jul 7.
- Results publication: PubMed 11952201Rothbaum BO, Hodges L, Anderson PL, Price L, Smith S. Twelve-month follow-up of virtual reality and standard exposure therapies for the fear of flying. J Consult Clin Psychol. 2002 Apr;70(2):428-32. doi: 10.1037//0022-006x.70.2.428.
- 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.
José MR Gutiérrez Maldonado, PhD study director
Senior PhD Supervisor
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-based exposure treatment with multimodal feedback (VRET-M), Virtual reality-based exposure treatment with bimodal feedback (VRET-B) and Imagery exposure treatment (IET) in people with Aerophobia and Virtual Reality Exposure Therapy, run by University of Barcelona at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José María MR Ribé Viñes, MD (676022376 ext. +34, jmribev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS). (time frame: Before the exposure treatment.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05939986, which also lists 2 linked publications.
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 11 Jul 2023.