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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Randomized Controlled Trial; Virtual Reality Exposure Therapy; Aerophobia
• Intervention / Treatment: Behavioral: Virtual reality-based exposure treatment with bimodal feedback (VRET-B); Behavioral: Imagery exposure treatment (IET); Behavioral: Virtual reality-based exposure treatment with multimodal feedback (VRET-M)

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 Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: José María MR Ribé Viñes, MD; Phone Number: +34 676022376; Email: jmribev@gmail.com
• Study Contact Backup: Name: Marta MS Ferrer Garcia, PhD; Phone Number: +34 933125114; Email: martaferrerg@ub.edu

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Faculty of Psychology. Universitat de Barcelona
    • Contact: José María MR Ribé Viñes, MD; Phone Number: +34 676022376; Email: jmribev@gmail.com
    • Contact: Marta MS Ferrer Garcia, PhD; Phone Number: +34 933125114; Email: martaferrerg@ub.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Barcelona
• Investigators: Study Director: José MR Gutiérrez Maldonado, PhD, Senior PhD Supervisor

Publications and helpful links

General 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.
• Rothbaum 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): October 15, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: July 2, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; Virtual Reality; Exposure; Fear of Flying; Vibrotactile Cues; Presence
• Other Study ID Numbers: 2926863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No