Clinical trial NCT05939986: A Protocol for a Virtual Reality Exposure Therapy for Fear of Flying.
Official title: Virtual Reality Exposure Therapy for Fear of Flying: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aerophobia
Virtual Reality Exposure Therapy
Randomized Controlled Trial
Anxiety
Keywords: Virtual Reality
Fear of Flying
Exposure
Vibrotactile Cues
Anxiety
Presence
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS).
timeFrame: Before the exposure treatment.
measure: Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS).
timeFrame: After eight sessions of treatment during eight weeks.
measure: Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS).
timeFrame: At 6 months follow-up after treatment termination.
measure: Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS).
timeFrame: At 12 months follow-up after treatment termination.
measure: Anxiety. Administering a Visual Analogue Scale (VAS-A).
timeFrame: Before the exposure treatment.
measure: Anxiety. Administering a Visual Analogue Scale (VAS-A).
timeFrame: After eight sessions of treatment during eight weeks.
measure: Anxiety. Administering a Visual Analogue Scale (VAS-A).
timeFrame: At 6 months follow-up after treatment termination.
measure: Anxiety. Administering a Visual Analogue Scale (VAS-A).
timeFrame: At 12 months follow-up after treatment termination.
Secondary outcomes:
measure: Anxiety. Administering a Visual Analogue Scale (VAS-A).
timeFrame: Before each exposure session.
measure: Anxiety. Administering a Visual Analogue Scale (VAS-A).
timeFrame: Every 2 minutes during each exposure session of 60 minutes.
measure: Anxiety. Administering a Visual Analogue Scale (VAS-A).
timeFrame: After eight sessions of treatment during eight weeks.
measure: Sense of Presence. Administering the Visual Analogue Scale (VAS-P).
timeFrame: Every 2 minutes during each exposure session of 60 minutes.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Faculty of Psychology. Universitat de Barcelona
Study officials:
affiliation: Senior PhD Supervisor
name: José MR Gutiérrez Maldonado, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.