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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05939986
• Other study ID #: 2926863
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: July 2023
• Source: University of Barcelona
• Contact: José María MR Ribé Viñes, MD
• Phone: 676022376
• Email: jmribev[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: January 31, 2024
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Randomized Controlled Trial
• Virtual Reality Exposure Therapy

Intervention

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.
• Virtual reality-based exposure treatment with bimodal feedback (VRET-B)
The VRET-B group will experience visual and auditive cues in the exposure sessions.
• Imagery exposure treatment (IET)
The IET group will experience its own subjective imagined environment without any external stimulation.

Locations

Country	Name	City	State
Spain	Faculty of Psychology. Universitat de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.