Emotional Processes in VR Exposure Treatment for Flight Phobia

Fear of Flying Clinical Trial

Official title:

Emotional Processes During a Randomized Controlled Trial of Virtual Reality Exposure Treatment for Flight Phobia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213859
• Other study ID #: 6557-19-SMC
• Status: Completed
• Phase: N/A
• Start date: December 24, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2023
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess emotional processes and their relation to treatment outcomes during Virtual reality exposure therapy for Flight Phobia. The researchers hypothesize treatment outcomes will be associated with positive changes in emotional constructs

Description:

Emotional constructs and emotion regulation capacities play a central role in the severity of anxiety disorders and are directly related to treatment outcomes in different anxiety disorders. In this study we will examine the relation between positive and negative affect, emotion regulation, emotional instability, emotional differentiation, experiential avoidance and therapy outcomes in participants undergoing Virtual Reality Exposure Therapy for Flight Phobia. We assume that treatment outcomes will be positively related to changes in the regulation, management and experience of emotions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of Flight phobia based on a structured interview
• possession of a smartphone with an active data plan

Exclusion Criteria:

• cardiovascular disease
• neurological disorders and history of epilepsy
• psychosis
• major depression
• suicidal behavior
• substance abuse.

Related Conditions & MeSH terms

• Fear of Flying

Intervention

Behavioral:
• VRET - Virtual Reality Exposure Therapy
VRET will include 4 weekly 1-hour sessions over the course of 4 weeks. The treatment protocol is based on the Virtual Reality (VR) treatment manual guidelines (Rothbaum & Hodges, 1997,1999) and includes psychoeducation, anxiety management training, cognitive restructuring and exposure. The first therapy session focuses on creating an individually-tailored conceptualization and treatment plan. Following this process, participant and therapist conduct a short introductory VR flight exposure simulation to familiarize the participant with the VRET apparatus. The VRET apparatus is an advanced, large-scale VR system that allows maximal immersion within the virtual environment. The second, third and fourth sessions include psychoeducation, relaxation training, cognitive restructuring and individually-tailored VR exposures (the therapist can manipulate the turbulence level and other flight-related variables to fit participants' fears and current progress).

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Idan Moshe Aderka

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in FAS (Flight Anxiety Situations Questionnaire) scores	The Flight Anxiety Situations Questionnaire (Van Grewen, Spinhoven, Van-Dyck, & Dikstra, 1999) is a 32-item, 5-point Likert-scale (1= no anxiety to 5=overwhelming anxiety). The FAS evaluates flight-related anxiety in various situations and includes 3 factors: generalized, anticipatory and in-flight anxiety.	Two weeks prior to therapy and one week after last therapy session (therapy includes 4 weekly 1-hour sessions over the course of 4 weeks)
Primary	Changes in FAM (Flight Anxiety Modality questionnaire) scores	The Flight Anxiety Modality (FAM) questionnaire (Van Grewen et al. 1999) assesses somatic and cognitive aspects of Flight Phobia. It includes 18 items that are rated using a 5-point scale (1=not at all, 5=very intensely). The somatic factor assesses physiological symptoms and the cognitive factor assesses anxiety-provoking cognitions	Two weeks prior to therapy and one week after last therapy session (therapy includes 4 weekly 1-hour sessions over the course of 4 weeks).