Emotional Processes in VR Exposure Treatment for Flight Phobia

NCT04213859 | Completed

• 1 other identifier: 6557-19-SMC
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Fear of Flying

Outcome Measures

Primary Outcomes (2)

• 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)

• 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).

Study Arms (2)

Virtual Reality Exposure Therapy (VRET)

EXPERIMENTAL

1. st stage: Participants will receive information about the study, complete measures of fear of flying and emotional variables, and undergo a diagnostic interview for flight phobia and additional disorders. 2. nd stage: During the week prior to treatment, participants will complete a brief measure of emotion-related variables every evening at a fixed time (08:00 pm). 3. rd stage: Participants will receive therapy for fear of flying using a Virtual Reality (VR) simulator. Therapy sessions will be held once a week during 4 weeks. Participants will complete a brief measure of emotion-related variables at a random time during the 12 hours before the therapy session at a random time during the 12 hours after the therapy session. This will occur for every therapy session. 4. th stage: After treatment, participants will complete measures of fear of flying and emotional variables.

Behavioral: VRET - Virtual Reality Exposure Therapy

control

NO INTERVENTION

1. st stage: Participants will receive information about the study, complete measures of fear of flying and emotional variables, and undergo a diagnostic interview for flight phobia and additional disorders. 2. nd stage: During five weeks no therapy will be administered. Participants will fill questionnaires as follows: During the first week, participants will complete emotional measures every evening at a fixed time (08:00 pm) 3. rd stage: During each of the following 4 weeks, participants will complete two emotional measures during a 24 hour period. 4. th stage: Participants will complete measures of fear of flying and emotional variables.

Interventions

VRET - Virtual Reality Exposure Therapy BEHAVIORAL

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).

Virtual Reality Exposure Therapy (VRET)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Idan Moshe Aderka: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Aerophobia

Study Officials

• Asaf Caspi, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D. Senior Lecturer

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: December 30, 2019
• Study Start: December 24, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)