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

NCT05939986 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-07-11

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Barcelona

    lead OTHER

Principal Investigators

  • José MR Gutiérrez Maldonado, PhD · Senior PhD Supervisor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2023-10-15
Completion
2024-01-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05939986 on ClinicalTrials.gov