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

NCT05939986 | Unknown DMC

• 1 other identifier: 2926863
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aerophobia; Virtual Reality Exposure Therapy; Randomized Controlled Trial; Anxiety

Keywords

Virtual Reality; Fear of Flying; Exposure; Vibrotactile Cues; Anxiety; Presence

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Anxiety. Administering a Visual Analogue Scale (VAS-A).

  Before each exposure session.

• Anxiety. Administering a Visual Analogue Scale (VAS-A).

  Every 2 minutes during each exposure session of 60 minutes.

• Anxiety. Administering a Visual Analogue Scale (VAS-A).

  After eight sessions of treatment during eight weeks.

• Sense of Presence. Administering the Visual Analogue Scale (VAS-P).

  Every 2 minutes during each exposure session of 60 minutes.

Study Arms (3)

Multimodal Virtual Reality Exposure Treatment (VRET-M)

EXPERIMENTAL

VRET with multimodal feedback including visual, auditory and vibrotactile cues.

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.

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.

Behavioral: Virtual reality-based exposure treatment with multimodal feedback (VRET-M); Behavioral: Virtual reality-based exposure treatment with bimodal feedback (VRET-B)

Interventions

Virtual reality-based exposure treatment with multimodal feedback (VRET-M) BEHAVIORAL

The VRET-M group will experience visual, auditive and vibrotactile cues in the exposure sessions.

Bimodal Virtual Reality Exposure Treatment (VRET-B); Imagery Exposure Treatment (IET)

Virtual reality-based exposure treatment with bimodal feedback (VRET-B) BEHAVIORAL

The VRET-B group will experience visual and auditive cues in the exposure sessions.

Imagery Exposure Treatment (IET); Multimodal Virtual Reality Exposure Treatment (VRET-M)

Imagery exposure treatment (IET) BEHAVIORAL

The IET group will experience its own subjective imagined environment without any external stimulation.

Bimodal Virtual Reality Exposure Treatment (VRET-B); Multimodal Virtual Reality Exposure Treatment (VRET-M)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5, American Psychiatric Association, APA, 2013) criteria for FoF.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Faculty of Psychology. Universitat de Barcelona

Barcelona, 08035, Spain

Location

Related Publications (2)

• 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.

  PMID: 16828460 BACKGROUND

• 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.

  PMID: 11952201 RESULT

MeSH Terms

Conditions

Aerophobia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• José MR Gutiérrez Maldonado, PhD

  Senior PhD Supervisor

  STUDY DIRECTOR

Central Study Contacts

José María MR Ribé Viñes, MD

CONTACT

676022376; jmribev@gmail.com

Marta MS Ferrer Garcia, PhD

CONTACT

933125114; martaferrerg@ub.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not-blinded study protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: July 11, 2023
• Study Start: September 1, 2023
• Primary Completion: October 15, 2023
• Study Completion: January 31, 2024
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)