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
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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