A Protocol for a Virtual Reality Exposure Therapy for Fear of Flying.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virtual Reality Exposure Therapy for Fear of Flying: Protocol for a Randomized Controlled Trial

Conditions
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Aerophobia, Virtual Reality Exposure Therapy, Randomized Controlled Trial, Anxiety

Intervention / Treatment
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* Behavioral: Virtual reality-based exposure treatment with multimodal feedback (VRET-M)
* Behavioral: Virtual reality-based exposure treatment with bimodal feedback (VRET-B)
* Behavioral: Imagery exposure treatment (IET)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5, American Psychiatric Association, APA, 2013) criteria for FoF. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal Virtual Reality Exposure Treatment (VRET-M)<br>VRET with multimodal feedback including visual, auditory and vibrotactile cues. | Behavioral: Virtual reality-based exposure treatment with bimodal feedback (VRET-B)<br>* The VRET-B group will experience visual and auditive cues in the exposure sessions.<br>Behavioral: Imagery exposure treatment (IET)<br>* The IET group will experience its own subjective imagined environment without any external stimulation.<br>|
| Active Comparator: Bimodal Virtual Reality Exposure Treatment (VRET-B)<br>VRET with bimodal feedback including visual and auditory cues. | Behavioral: Virtual reality-based exposure treatment with multimodal feedback (VRET-M)<br>* The VRET-M group will experience visual, auditive and vibrotactile cues in the exposure sessions.<br>Behavioral: Imagery exposure treatment (IET)<br>* The IET group will experience its own subjective imagined environment without any external stimulation.<br>|
| Active Comparator: Imagery Exposure Treatment (IET)<br>Imagery exposure treatment without sensory cues. | Behavioral: Virtual reality-based exposure treatment with multimodal feedback (VRET-M)<br>* The VRET-M group will experience visual, auditive and vibrotactile cues in the exposure sessions.<br>Behavioral: Virtual reality-based exposure treatment with bimodal feedback (VRET-B)<br>* The VRET-B group will experience visual and auditive cues in the exposure sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | At 12 months follow-up after treatment termination. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | Every 2 minutes during each exposure session of 60 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Virtual Reality, Fear of Flying, Exposure, Vibrotactile Cues, Presence