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

July 2, 2023 updated by: José María Ribé Viñes, University of Barcelona

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: José María MR Ribé Viñes, MD
  • Phone Number: +34 676022376
  • Email: jmribev@gmail.com

Study Contact Backup

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
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.
Before the exposure treatment.
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.
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).
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.
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).
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.
At 12 months follow-up after treatment termination.
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).
Before the exposure treatment.
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).
After eight sessions of treatment during eight weeks.
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).
At 6 months follow-up after treatment termination.
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).
At 12 months follow-up after treatment termination.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxiety. Administering a Visual Analogue Scale (VAS-A).
Time Frame: Before each exposure session.
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).
Time Frame: Every 2 minutes during each exposure session of 60 minutes.
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).
Time Frame: After eight sessions of treatment during eight weeks.
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).
Time Frame: Every 2 minutes during each exposure session of 60 minutes.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Barcelona

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: José MR Gutiérrez Maldonado, PhD, Senior PhD Supervisor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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