Fear of FlyingNCT04213859

Emotional Processes in VR Exposure Treatment for Flight Phobia

A study testing VRET - Virtual Reality Exposure Therapy in people with Fear of Flying, run by Idan Moshe Aderka at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Fear of Flying
What is being tested?: VRET - Virtual Reality Exposure Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteIsrael
Study dates: 24 Dec 2019to 1 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site

Sheba Medical Center
Ramat Gan, Israel

Other trials in Israel

About this study

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

Read the detailed 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.

Conditions: Fear of Flying
Being tested: VRET - Virtual Reality Exposure Therapy
Medical subject headings: Aerophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VRET - Virtual Reality Exposure TherapyBehavioural
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).

Study groups in NCT04213859
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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. We used the total score of the FAS which ranges from 32 to 160 with higher values indicating more flight-related anxiety. Thus, higher values reflect worse outcomes, and lower values reflect better outcomes. The total score is obtained by summing all items.
Measured: 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). We used the total score of the FAM which ranges from 18 to 90, with higher values indicating more flight-related anxiety. Thus, higher values reflect worse outcomes, and lower values reflect better outcomes. The total score is obtained by summing all items.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Dec 20191 Sep 2023

First posted30 Dec 2019
Study start24 Dec 2019
Primary completion1 Sep 2023
Study completion1 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Fear of FlyingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04213859
Sponsor's protocol ID: 6557-19-SMC
Status last verified: May 2026
First submitted: 24 Dec 2019
Last updated: 17 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Emotional Processes During a Randomized Controlled Trial of Virtual Reality Exposure Treatment for Flight Phobia
ClinicalTrials.gov ID: NCT04213859
Acronym / sponsor ID: 6557-19-SMC
Conditions: Fear of Flying
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Idan Moshe AderkaUniversity, hospital or other
Study start: 24 Dec 2019 (actual)
Primary completion: 1 Sep 2023 (actual)
Study completion: 1 Sep 2023 (actual)
First posted: 30 Dec 2019 (actual)
Results: Posted 17 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Virtual Reality Exposure Therapy (VRET)	Experimental	Behavioral: VRET - Virtual Reality Exposure Therapy1. 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.
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

cardiovascular disease
neurological disorders and history of epilepsy
psychosis
major depression
suicidal behavior

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VRET - Virtual Reality Exposure TherapyVRET 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).	Behavioural	Virtual Reality Exposure Therapy (VRET)

Primary outcome

Changes in FAS (Flight Anxiety Situations Questionnaire) Scores
Time frame: 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)
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. We used the total score of the FAS which ranges from 32 to 160 with higher values indicating more flight-related anxiety. Thus, higher values reflect worse outcomes, and lower values reflect better outcomes. The total score is obtained by summing all items.
Changes in FAM (Flight Anxiety Modality Questionnaire) Scores
Time frame: 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).
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). We used the total score of the FAM which ranges from 18 to 90, with higher values indicating more flight-related anxiety. Thus, higher values reflect worse outcomes, and lower values reflect better outcomes. The total score is obtained by summing all items.

Results and safety

Results posted to the registry on 17 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	42	42
Waitlist	42	42

Primary outcome: Changes in FAS (Flight Anxiety Situations Questionnaire) Scores

Time frame: 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). Mean (Standard Deviation). Unit: Score on the scale

Measure	Treatment n = 42	Waitlist n = 42
Value	-19.36 (17.47)	-3.76 (13.87)

Primary outcome: Changes in FAM (Flight Anxiety Modality Questionnaire) Scores

Time frame: 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).. Mean (Standard Deviation). Unit: Score on the scale

Measure	Treatment n = 42	Waitlist n = 42
Value	-13.03 (13.05)	-0.51 (10.85)

Adverse events

Time frame: From enrollment to treatment completion, up to 10 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Waitlist	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Asaf Caspi, MD principal investigator

Sheba Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VRET - Virtual Reality Exposure Therapy in people with Fear of Flying, run by Idan Moshe Aderka at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in FAS (Flight Anxiety Situations Questionnaire) Scores (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04213859.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.